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Addressing Overdiagnosis in Thyroid Cancer
Rochester, MN
The purpose of this study is to develop a radiological multivariate model to distinguish between malignant and benign CT-identified detected thyroid nodules.
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American Society of Hematology Research Collaborative’s Data Hub Multiple Myeloma Program
Rochester, MN
The purpose of this long-term data collection of patients with benign or malignant hematologic diseases is to collect patient demographics, disease characteristics, genomic and molecular data, laboratory data, pathology, radiographic reports, clinical status, quality of life, mediations, and dosing information.
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FORTIFI-HN01: A Study Of Ficerafusp Alfa (BCA101) Or Placebo In Combination With Pembrolizumab In First-Line PD-L1-pos, R Or M HNSCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
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Belzupacap Sarotalocan (AU-011) Treatment Compared To Sham Control For Primary Indeterminate Lesions Or Small Choroidal Melanoma
Rochester, MN
The purpose of this study is to determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
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Ph. 1, Evaluation Of Safety, Tolerability, PK, Anti-tumor Activity Of STP707 IV In Subjects With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
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Financial Difficulty In Patients With Blood Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze the financial difficulties experienced by patients undergoing treatment for multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). It is composed of a patient survey (n=250), a physician survey (n=100), and a practice survey completed by each site enrolling patients onto this study. A subset of enrolled patients (n=35) will be invited to participate in an optional second telephone interview (Appendix D). This study will measure the prevalence of patient-reported financial difficulty, specific financial burdens and resources currently available to patients and from practices to assist with patient financial navigation.
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A Study To Evaluate ELU001 In Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of Part 1 (dose escalation) of this study is to establish the MTD and/or RP2D of ELU001 in subjects who have advanced, recurrent or refractory FRα overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive.
The primary purpose of Part 2 (Tumor Group Expansion Cohorts) of this study is to evaluate anti-tumor activity of ELU001 in subjects who have moderate or high FRα overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive.
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Intravital Microscopy (IVM) In Patients With Peritoneal Carcinomatosis (PC)
Jacksonville, FL
This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.
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Testing The Effect Of M1774 On Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and who have a mutation in the speckle type BTB/POZ protein (SPOP) gene. M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Alternate Doses And Dosing Schedules Of Belantamab Mafodotin For The Treatment Of Triple-Class Recurrent And/or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this study is to assess the 24-week grade 3/4 keratopathy-free rate of an alternative dose/dosing schedule for belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (RRMM).
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Retrospective Chart Review Of Real-World Treatment Outcomes Of Locally Advanced Unresectable Or Metastatic Urothelial Cancer Based On HER2 Expression
Scottsdale/Phoenix, AZ
The purpose of this study is to estimate the real-world Objective Response Rate (rwORR) to standard therapy in subjects with locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC) by human epidermal growth factor receptor 2 (HER2) status by immunohistochemistry (IHC) and in situ hybridization (ISH) scoring.
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Testing The Use Of The Combination Of Selumetinib And Olaparib Or Selumetinib Alone Targeted Treatment For RAS Pathway Mutant Recurrent Or Persistent Ovarian And Endometrial Cancers, A ComboMATCH Treatment Trial
Jacksonville, FL; Rochester, MN
The purpose of this phase II ComboMATCH treatment trial is to compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway.
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Characterizing Ultrasound Vibroelastography Features Of Ocular Tumors
Rochester, MN
The purpose of this study is to characterize ultrasound vibro-elastography features of ocular tumors.
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Hepatobiliary Cancer Research Engagement Among Patients And Communities
Jacksonville, FL
The purpose of this study is to assess community needs and attitudes toward participating in hepatobiliary cancer research for relevant, translatable, and sustainable research partnership.
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Sexual And Gender Minority (SGM) For Cancer Studies
Rochester, MN
The purpose of this study is to document the beliefs, attitudes, and experiences regarding NIH cancer research participation expressed by SGM cancer patients.
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A Study To Establish A Research Tissue Bank For Myeloproliferative Neoplasms
Scottsdale/Phoenix, AZ
The purpose of this study is to credential novel therapeutic approaches which can then be transitioned to the clinic for near-term mechanism based clinical trials in this research consortium. There is a need for new treatments for myelofibrosis (MF) patients based on laboratory insight into disease pathogenesis. We will use primary patient samples to understand how different genetic mutations contribute to MF development and to test novel treatment approaches.
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Safety And Anti-leukemic Activity Of Vodobatinib (K0706) For Treatment Refractory/Intolerant CML Failing ≥3 Prior Chronic Myeloid Leukemia Therapies
Jacksonville, FL
The purpose of this study is determine the safety, tolerability, pharmacokinetics and activity of K0706.
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A Study To Evaluate Encapsulated Rapamycin To Prevent Progression Of Familial Adenomatous Polyposis In Patients
Scottsdale/Phoenix, AZ
The purposes of this study are to analyze the frequency and severity of adverse events associated with low-dose encapsulated rapamycin in Familial Adenomatous Polyposis (FAP), to determine the recommended phase 2 dose (RP2D) based on assessment of safety, long-term tolerability, optimal blood levels, and clinical benefit, and to determine the effectiveness of eRapa in delaying polyp progression in patients with FAP compared to historic controls.
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Caris Biorepository Research Protocol
Scottsdale/Phoenix, AZ
The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients.
The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.
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A Study Of Ifinatamab Deruxtecan In Subjects With Pretreated Advanced Or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Scottsdale/Phoenix, AZ; Rochester, MN
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).
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Study Of Lunresertib Alone Or In Combination With RP-3500 Or Debio 0123 In Patients With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
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A Study Of Intravesical BCG In Combination With ALT-803 In Patients With Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
For Cohort A, the purpose of this study is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate using cystoscopy, confirmatory bladder biopsy, and urine cytology. For Cohort B, the purpose is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival (DFS) using cystoscopy, confirmatory bladder biopsy, and urine cytology.
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HTN Management And Cardiovascular Adverse Event Prevention In B-Cell Malignancies Undergoing BTKi
Rochester, MN
The purpose of this study is to prospectively define the incidence of new and/or worsening hypertension in patients with B-cell malignancies on Bruton Tyrosine Kinase Inhibitors.
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A Study To Investigate The Safety And Efficacy Of KQB168 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?
Participants will:
* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after ...
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Risk Factors for Recurrence in Endometrial Cancer Patients
Rochester, MN
The purpose of this study is to identify those clinical, immunochemical, or molecular risk factors associated with an increased risk of distant recurrence in “high-intermediate” risk endometrial cancer patients.
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64Cu-SAR-bisPSMA And 67Cu-SAR-bisPSMA For Identification And Treatment Of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Rochester, MN
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
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A Study Of Poziotinib In Patients With NSCLC With EGFR Or HER2 Exon 20 Insertion Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the efficacy and the safety/tolerability of poziotinib in patients with NSCLC exon 20 insertion mutations.
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A Study To Evaluate The Safety And Effectiveness Of Intratumoral And Intravenous Injection Of Vesicular Stomatitis Virus Expressing Human Interferon Beta, And Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) In Patients With Metastatic Ocular Melanoma And Previously Treated Patients With Unresectable Stage III/IV Cutaneous Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety profile and maximum tolerated dose (MTD) of VSV-IFNß-TYRP1 therapy when administered by IV and IT injection in patients with previously treated metastatic melanoma.
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INdividualized Screening Trial Of Innovative Glioblastoma Therapy (INSIGhT)
Rochester, MN
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115
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A Study Of Androgen Annihilation In High-Risk Biochemically Relapsed Prostate Cancer
Scottsdale/Phoenix, AZ
This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
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A Study Of The Safety And Drug/Body Interactions Of BGB-3111 For Patients With B-Cell Lymphoid Malignancies
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and treatment effects of a new drug known as BGB-3111 in patients who have B-cell lymphoid malignancies.
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A Study To Evaluate Dabrafenib And Trametinib With Or Without Hydroxychloroquine In Advanced Melanoma
Rochester, MN
The purpose of this study is to investigate how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
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A Phase 1/2 Study Of STP938 For Adult Subjects With Relapsed/Refractory B-Cell And T-Cell Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of STP938 as a single agent in adult subjects with R/R B-cell and T-cell lymphomas.
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Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with regorafenib. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).
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Low-grade UTUC Treated With Nadofaragene Firadenovec Administered To Renal Pelvis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.
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A Study To Investigate The Safety And Efficacy Of KQB365 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365.
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A Study Of Mocertatug Rezetecan In Combination With Anti-cancer Therapies For Advanced Solid Tumors
Rochester, MN
Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable Mocertatug Rezetecan (Mo-Rez) is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available ...
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A Study Of Effect Of Megakaryocytes And Platelets In Breast Cancer
La Crosse, WI
The purpose of this study is to determine how megakarocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survivial and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakatocyte survival and function. Through chart review, the study team will look at the relationship different blood components and different breast cancer diagnosis.
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A Study Of SGN-B7H4V In Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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Plasma Proneurotensin As A Predictive Biomarker For Breast Cancer In Genetically Predisposed Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether elevated fasting plasma proneurotensin levels are common in patients genetically predisposed to breast cancer.
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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
Rochester, MN
The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).
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Diagnosing Lymphangioleiomyomatosis from Glycoprotein Non-Metastatic Melanoma Protein B
Rochester, MN
The purpose of this study is to analyze if levels of glycoprotein non-metastatic melanoma protein B be elevated in patients with LAM..
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A Study Of Abenacianine (VGT-309) To Identify Cancer When Undergoing Surgery For Cancer In The Lung
Rochester, MN
The purpose of this study is assess the efficacy of abenacianine with near-infrared (NIR) imaging as an adjunct for lesion visualization and surgical guidance when compared to standard surgical techniques in subjects undergoing surgery for suspected or proven cancer in the lung.
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Dynamics Of Clinical Trial Discussions In Oncology To Identify Patient Barriers And Help Develop A Patient-centered Intervention To Increase Participation In Clinical Trials
Rochester, MN
The purposes of this study are to richly describe the content and dynamics of clinical trial discussions in oncology and compare the knowledge, beliefs, and attitudes of oncology patients, caregivers, and clinicians related to clinical trials, and to develop a multifaceted, patient-centered intervention for increasing patient understanding of and participation in clinical trials in oncology.
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Hereditary Cancer Registry
Jacksonville, FL
The purpose of this study is to develop and maintain a clinical registry database of all patients seen at Mayo Clinic Florida who have completed genetic testing through Mayo Clinic Florida or are seen due to a previously identified hereditary cancer risk.
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Iobenguane I-131 Or Crizotinib And Standard Therapy In Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma Or Ganglioneuroblastoma
Rochester, MN
Despite recent improvements in outcome for children with newly diagnosed high-risk neuroblastoma, cure rates remain unsatisfactory.Further, these gains have been the result of interventions during the Consolidation (tandem autologous stem cell transplant) and Post-Consolidation (dinutuximab immunotherapy) phases of treatment, while rates of disease control during Induction have not improved in recent COG trials. The current phase 3 trial seeks to improve the event-free survival (EFS) for children with high-risk neuroblastoma through early integration of promising novel targeted therapies: targeted radiopharmaceutical therapy with 131I-MIBG or the ALK inhibitor, crizotinib. After enrollment, patients will receive one cycle of Induction chemotherapy. Subsequent therapy ...
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A Study To Assess Disease Activity And Adverse Events Of Intravenous (IV) Telisotuzumab Vedotin Compared To IV Docetaxel In Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with Non-Small Cell Lung Cancer (NSCLC) who have previously been treated.
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In-home Intravesical Chemotherapy For The Treatment Of Bladder Cancer, INVITE Trial
Jacksonville, FL
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. ...
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Collection Of Primary Retroperitoneal Sarcoma Data, Radiological, And Pathological Material For The Transatlantic Australasian Retroperitoneal Sarcoma Working Group
Jacksonville, FL
The purpose of this study is to prospectively collect standardized clinical data and radiological and pathological material from primary retroperitoneal sarcomas RPS patients treated with surgery at reference centers. Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).
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Safety And Toxicity Study Of Intravesical Instillation Of TARA-002 In Adults With High-grade, Non-muscle Invasive Bladder Cancer
Jacksonville, FL; Rochester, MN
The primary objective of this study is to characterize the safety and toxicity profile of TARA-002 administered intravesically.
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Understanding Financial Toxicity In Management Of Advanced Prostate Cancer From Qualitative Approach
Rochester, MN
The purpose of this study is to identify characteristics of financial toxicity unique to advanced prostate cancer, especially those areas not assessed through current objective measures, and describe how can these areas inform potential interventions to ameliorate financial toxicity.
This aim will be accomplished through qualitative focus group study of advanced prostate cancer patients who exhibit both extremes of financial toxicity. Findings will be presented in a joint display with quantitative survey data obtained in a prior study.
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Establishing A Possible Correlation Between Chest Wall And Breast Lymphedema
Rochester, MN
The purpose of this study is to address current gaps in research by further establishing a possible correlation between chest wall and breast lymphedema, as measured by the Delfin Moisture Meter D Compact, to a decreased quality of life (LymQOL-midline questionnaire) as well as decreased shoulder function (DASH questionnaire).
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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
Rochester, MN
The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).
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Diagnosing Lymphangioleiomyomatosis from Glycoprotein Non-Metastatic Melanoma Protein B
Rochester, MN
The purpose of this study is to analyze if levels of glycoprotein non-metastatic melanoma protein B be elevated in patients with LAM..
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Iobenguane I-131 Or Crizotinib And Standard Therapy In Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma Or Ganglioneuroblastoma
Rochester, MN
Despite recent improvements in outcome for children with newly diagnosed high-risk neuroblastoma, cure rates remain unsatisfactory.Further, these gains have been the result of interventions during the Consolidation (tandem autologous stem cell transplant) and Post-Consolidation (dinutuximab immunotherapy) phases of treatment, while rates of disease control during Induction have not improved in recent COG trials. The current phase 3 trial seeks to improve the event-free survival (EFS) for children with high-risk neuroblastoma through early integration of promising novel targeted therapies: targeted radiopharmaceutical therapy with 131I-MIBG or the ALK inhibitor, crizotinib. After enrollment, patients will receive one cycle of Induction chemotherapy. Subsequent therapy ...
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Dynamics Of Clinical Trial Discussions In Oncology To Identify Patient Barriers And Help Develop A Patient-centered Intervention To Increase Participation In Clinical Trials
Rochester, MN
The purposes of this study are to richly describe the content and dynamics of clinical trial discussions in oncology and compare the knowledge, beliefs, and attitudes of oncology patients, caregivers, and clinicians related to clinical trials, and to develop a multifaceted, patient-centered intervention for increasing patient understanding of and participation in clinical trials in oncology.
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Hereditary Cancer Registry
Jacksonville, FL
The purpose of this study is to develop and maintain a clinical registry database of all patients seen at Mayo Clinic Florida who have completed genetic testing through Mayo Clinic Florida or are seen due to a previously identified hereditary cancer risk.
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A Study Of Abenacianine (VGT-309) To Identify Cancer When Undergoing Surgery For Cancer In The Lung
Rochester, MN
The purpose of this study is assess the efficacy of abenacianine with near-infrared (NIR) imaging as an adjunct for lesion visualization and surgical guidance when compared to standard surgical techniques in subjects undergoing surgery for suspected or proven cancer in the lung.
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Safety And Toxicity Study Of Intravesical Instillation Of TARA-002 In Adults With High-grade, Non-muscle Invasive Bladder Cancer
Jacksonville, FL; Rochester, MN
The primary objective of this study is to characterize the safety and toxicity profile of TARA-002 administered intravesically.
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A Study To Assess Disease Activity And Adverse Events Of Intravenous (IV) Telisotuzumab Vedotin Compared To IV Docetaxel In Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with Non-Small Cell Lung Cancer (NSCLC) who have previously been treated.
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In-home Intravesical Chemotherapy For The Treatment Of Bladder Cancer, INVITE Trial
Jacksonville, FL
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. ...
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Collection Of Primary Retroperitoneal Sarcoma Data, Radiological, And Pathological Material For The Transatlantic Australasian Retroperitoneal Sarcoma Working Group
Jacksonville, FL
The purpose of this study is to prospectively collect standardized clinical data and radiological and pathological material from primary retroperitoneal sarcomas RPS patients treated with surgery at reference centers. Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).
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The Effects Of Acute And Chronic Exercise On Immune Phenotype Of Indolent Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase ...
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Study Of VS-6766 + Adagrasib In KRAS G12C NSCLC Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of Avutometinib combined with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.
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INCB161734 For Advanced Or Metastatic Solid Tumors With KRAS G12D Mutation
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
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Investigations Of Reproductive Cancers In Women (PROACTION:)
Rochester, MN
The purpose of this study is to validate a non-invasive diagnostic test with both high-sensitivity and negative predictive value (NPV) for its ability to rule out endometrial cancer.
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Specimen Collection From Participants Due For Colorectal Cancer Screening, Surveillance, Or Treatment
Rochester, MN
The purpose of this study is to collect de-identified, clinically characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays and devices for early detection of colorectal neoplasia.
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A Study Of RLY-4008 In Patients With Intrahepatic Cholangiocarcinoma And Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D), safety profile, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of RLY-4008 in patients with ICC and other advanced solid tumors.
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A Study To Evaluate Belinostat And Guadecitabine Or ASTX727 To Treat Unresectable And Metastatic Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well belinostat and SGI-110 (guadecitabine) or ASTX727 work in treating patients with conventional chondrosarcoma that cannot be removed by surgery (unresectable) and has spread to other places in the body (metastatic). Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as guadecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving belinostat and guadecitabine may lower the chance of chondrosarcoma growing or ...
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A Study To Evaluate HH2853 In Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas Or Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (how a drug moves within the body) and clinical activity of HH2853, an EZH1/2 Inhibitor, in patients with relapsed/refractory Non-Hodgkin's lymphomas or advanced solid tumors.
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An Investigational Scan (Ga-68 PSMA-11 PET/CT) For Detection Of Disease Recurrence Or Progression In Patients With Glioma
Rochester, MN
This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a ...
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A Study Of Selpercatinib Following Definitive Locoregional Treatment In Participants With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to compare Event-Free Survival (EFS) of participants in the primary analysis population with Stage II-IIIA RET fusion-positive Non-small Cell Lung Cancer (NSCLC) treated with selpercatinib versus placebo.
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Studying The Effect Of Levocarnitine In Protecting The Liver From Chemotherapy For Leukemia Or Lymphoma
Rochester, MN
The purpose of this study is to compare the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma.
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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well alisertib works in treating patients with advanced or metastatic sarcoma. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with alemtuzumab and will see how well they work in treating patients with recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).
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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
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Developing Criteria For Treatment Of Neurofibromatosis Type 1 Associated Optic Pathway Glioma
Rochester, MN
The purpose of this research study is to understand the natural history of vision in patients with OPG and determine if there are factors (e.g. age at diagnosis, male/female, tumor location, features of the MRI exam, etc) that predict future vision loss or change in tumor size.
Another purpose of the study is to collect and store blood and tissue samples to use for future research to evaluate if there are certain variations in DNA, RNA, or proteins that predict the likelihood of an OPG to grow or cause vision loss.
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Calaspargase Pegol On The Coagulation System In Pediatric Acute Lymphoblastic Leukemia (ALL) Patients
Rochester, MN
The purpose of this study is to evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in Pediatric Acute Lymphoblastic Leukemia (ALL) patients.
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A Study Of Leukemia Inhibitory Factor Biomarker Monitoring Progression And Treatment Response Of Locally-advanced Unresectable And Metastatic Pancreatic Cancer Therapies
Jacksonville, FL
The purpose of this study is to determine if LIF (Leukemia Inhibitory Factor) level is positively correlated with disease progression and CA19-9 level in Pancreatic Ductal Adenocarcinoma (PDAC) patients and is a reliable biomarker of response.
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Novel Total Body Photography System For Accessible And Accurate Skin Cancer Screening
Rochester, MN
The overall goal of this pilot study is to assess initial quality and feasibility of a novel protoype TBP system that may be used in the future for accurate and accessible skin cancer screening called Skinmap. Skinmap’s automatic anatomical registration will be sufficient to permit accurate alignment of baseline overlays on current imagery for visual and automated detection of changes 1mm or greater on 95% of exposed skin in baseline and current image sets. The teams of Triangulate Labs and Mayo Clinic Enterprise Dermatology propose to validate, refine, and explore the clinical utility of Skinmap.
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A Study Of Abiraterone Acetate Plus Prednisone With Or Without Abemaciclib In Participants With Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
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A Study To Examine Financial Distress In Patients Undergoing Treatment Of Locally-advanced Rectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the needs and gap in our understanding of financial burden experienced by rectal cancer patients from a patient perspective to help provide patient centered care and improve psychosocial outcomes of this group.
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A Study To Evaluate Myeloma-Developing Regimens Using Genomics (MyDRUG)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of ...
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Study Of GI-102 And PD-1 In Glioblastoma
Rochester, MN
The purpose of this study to assess pharmacodynamic (PD) changes in tumor tissue.
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A Clinical Study Of Ifinatamab Deruxtecan (I-DXd) In People With Metastatic Prostate Cancer (MK-2400-001)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
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A Study To Assess A New Personalized Tool For Colorectal Cancer Peritoneal Disease Treatment
Rochester, MN
The objectives of this study are to genomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.
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Patient And Caregiver Perspective About Financial Distress Of Cancer Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to understand the need and gap in interventions addressing financial burden from a patient perspective, and develop a psychoeducational intervention directed towards decreasing financial distress in patients undergoing cancer treatment based on the knowledge gained.
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A Study Of AMG 757 In Participants With Neuroendocrine Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability of AMG 757, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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Immune Archetecture Of Stage 4 Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify who may or may not be a good fit for specific cancer treatments. Investigators will be attempting to identify markers that may make someone resistant to specific therapies in order to avoid harsh treatments that would not be effective or target more effective treatments at the offset.
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PTT-936, An Alpha Kinase 1 (ALPK1) Activator, Alone Or In Combination With Anti-PD-1/L1 In Patients With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of a pharmacologically active dose (PAD) range of PTT-936, which may include identification of the MTD, administered as a single agent in patients with advanced unresectable or metastatic solid tumors who have progressed after exhaustion of standard of care (SOC) or a SOC is not available.
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5-strain Probiotic Formulation In Hormone Receptor-positive Breast Cancer Receiving Aromatase Inhibitor To Prevent Bone Loss
Jacksonville, FL
The purpose of this is a prospective, pilot, single-arm study to evaluate the median percent change in C-terminal telopeptide of type 1 collagen (CTx) after WBF-038 in early-stage breast cancer patients receiving aromatase inhibitors after 3- and 12-month treatment.
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Establishing a Platform for Personalized Approach to the Management of Rectal Adenocarcinoma Using Patient-Derived Tumoroids and Organoids
Jacksonville, FL
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
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A Study to Evaluate the Impact of a Pharmacist-led Oral Anticancer Medication (OAM) Program on Patient Outcomes
La Crosse, WI
The purpose of this study is to evaluate the impact of integrating a pharmacist-led OAM education program within the interdisciplinary oncology team at the Stephen and Barbara Slaggie Family Cancer Center and Blood Disorders Center within Mayo Clinic Health System – La Crosse.
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PSMA PET For Metastatic Adenoid Cystic Carcinoma (ACC)
Rochester, MN
The purpose of this study is to evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.
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Dual BET And CBP/p300 Inhibitor In Patients With Targeted Advanced Solid Tumors And Hematological Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
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A Study Of Ripretinib Vs Sunitinib In Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) by IRR of ripretinib vs sunitinib using modified Response Evaluation Criteria in Solid Tumors v1.1 – GIST-specific (mRECIST). Also, to compare the overall survival (OS) of ripretinib vs sunitinib.
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Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed By Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance In Treatment-Naïve Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to determine the proportion of patients in complete response (CR) with peripheral blood (PB) MRD-negativity after up to 12 cycles of maintenance treatment with either the doublet of zanubrutinib/rituximab, or the triplet of zanubrutinib/rituximab/sonrotoclax, following BRAZAN induction (3 cycles of BR + zanubrutinib and 3 cycles of rituximab + cytarabine). Peripheral blood MRD will be measured by the clonoSEQ® assay, with the threshold for MRD negativity set at a sensitivity level of 1 x 10-5 (uMRD5).
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Gut Microbiome In Solid Tumor Management
Rochester, MN
The purpose of this research is to study the impact of the bacteria in the intestine (gut) on the efficacy and side effects of the anticancer therapies.
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A Study Of JNJ-69086420, An Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (HK2) For Advanced Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).
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A Study To Evaluate Oncologic Outcomes And Quality Of Life In Sinonasal Cancer Patients
Rochester, MN
This is a multi-site study with several other leading centers studying sinonasal cancers. The purpose of this study is to gain a better understanding of the treatment and significant morbidity associated with sinonasal cancer and identify the impact this disease has on quality of life. In addition, several additional endpoints will focus on survival and optimal treatment strategies. Additional components will also included genomic and molecular analysis of tumor tissue as we search for novel targets for therapy.
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Surgical Drain Fluid For Detection Of Molecular Residual Disease In Patients With Non-small Cell Lung Cancers
Rochester, MN
The purpose of this study is to characterize post-surgical drain fluid, pleural fluid, collected from the drainage device placed during surgery, as a biomarker for molecular residual disease in patients with non small cell lung cancer.
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CATALINA-2: A Clinical Study Of TORL-1-23 In Platinum-resistant Ovarian Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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Gleolan For Visualization Of Newly Diagnosed Or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
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A Phase 3 Study To Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy In Previously Treated Head And Neck Squamous Cell Carcinoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
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Safety And Tolerability Of TNG908 In Patients With MTAP-deleted Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first in human study in patients with deleted Methylthioadenosine phosphorylase (MTAP) advanced or metastatic solid tumors is to detertamine dose escalation in part one and dose expansion in specific MTAP-deleted tumor types.
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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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A Study Of Intravesical Enfortumab Vedotin For Treatment Of Patients With Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to test drug enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
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Two Studies For Patients With High Risk Prostate Cancer Testing Less Intense Treatment For Patients With A Low Gene Risk Score And Testing A More Intense Treatment For Patients With A High Gene Risk Score
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Rochester, MN
The puporse of this trial is to compare less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses ...
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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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Global Trial In APG2575 For Patients With CLL/SLL
Jacksonville, FL
The purpose of this study is to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors
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A Study To Evaluate Gleolan To Enhance Tumor Visualization In Patients With Newly-diagnosed Or Recurrent Meningioma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX).
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Study Of INBRX-109 In Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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A Study To Evaluate ALN-BCAT In Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
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A Study Of SPX-303, A Bispecific Antibody Targeting LILRB2 And PD-L1 In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
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A Study To Explore Tumor Biology In Metastatic Esophageal And Gastric Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.
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Iberdomide, Daratumumab, Bortezomib, And Dexamethasone For Treatment Of Newly Diagnosed Multiple Myeloma, IDEAL Study
Rochester, MN
The purpose of this study is to find the maximum tolerated dose of iberdomide for patients newly diagnosed with multiple myeloma, and to determine response rate during induction treatment when combined with daratumumab, bortezomib and dexamethansone.
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Cancer screening practices of individuals with Lynch Syndrome
Rochester, MN
This is a survey study to describe how women with Lynch syndrome are being screened for gynecologic cancer risk, their perception of cancer risk, and uptake of risk reducing surgery.
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JSI-1187-01 Monotherapy And In Combination With Dabrafenib For Advanced Solid Tumors With MAPK Pathway Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
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Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations
Jacksonville, FL; Rochester, MN
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...
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A Randomized Phase 2 Trial Of Axitinib And TRC105 Versus Axitinib Alone In Patients With Advanced Or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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Phase 3 Study Of DCC-2618 Vs Placebo In Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Jacksonville, FL; Rochester, MN
This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo
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A Study To Analyze The Safety And Effectiveness Of The NanoKnife® System In Unresectable Stage 3 Pancreatic Adenocarcinom Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System for the ablation of unresectable Stage 3 pancreatic adenocarcinoma (Stage 3 pancreatic cancer).
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Financial Toxicity Among Patients In Phase I Clinical Trials
Rochester, MN
As medical care in the United States becomes increasingly expensive, cost stewardship is a necessary component of delivering high value care. Cancer patients require additional protection from unmanageable costs, as the average out of pocket (OOP) cost during the first month of diagnosis is as high as $2900. Financial toxicity (FT) describes the adverse impact that the cost of treatment imposes upon our patients. Over the last five years, FT has become a well-recognized adverse impact of a cancer diagnosis. FT not only decreases the patient's quality of life, but also patients who file bankruptcy during cancer treatment ...
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Topical Cannabidiol (CBD) For The Treatment Of Chemotherapy-induced Peripheral Neuropathy
Albert Lea, MN; Mankato, MN; Rochester, MN
The primary purpose of this study is to evaluate whether topical CBD improves chemotherapy-induced peripheral neuropathy (CIPN), compared to placebo, and to evaluate side effects from topical CBD cream use, compared to placebo.
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A Study Of NT-175 In Adult Subjects With Unresectable, Advanced, And/or Metastatic Solid Tumors That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.
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Testing The Addition Of An Anti-Cancer Drug, Gemcitabine, To Usual Treatment (BCG Alone) In People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with ...
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A Study to Assess Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Rochester, MN
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. Note: The standard drug used for the ...
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Efficacy And Safety Of Tislelizumab In Combination With Fruquintinib In Participants With Selected Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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Retrospective Study of Adult Acute Myeloid Leukemia and the Impact on Clinical Characteristics & Outcomes After Therapy
Jacksonville, FL
The purpose of this study is to perform a retrospective review of adult patients diagnosed with AML at all 3 Mayo Clinic sites over the past 25 years in order to identify prior exposures documented at presentation.
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Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
Rochester, MN
The purpose of this study is to evaluating the clinical outcomes of grid therapy.
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Screening and Staging of Benign vs Malignant Pelvic Abnormalities
Rochester, MN
The purpose of this study is to integrate GEHC’s AIR Recon DL (ARDL) technique to current protocols while reducing overall scan time.
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Mayo Clinic Vestibular Schwannoma Quality of Life Index Assessment
Rochester, MN
The purpose of the study is to conduct cognitive testing of the recently published Mayo Clinic Vestibular Schwannoma Quality of Life (VSQOL) Index.
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Quality of life in older adults with lymphomas
Scottsdale/Phoenix, AZ
The purpose of this study is to identify factors important to decision-making for older adults with indolent lymphomas and to identify minimum clinically significant differences in QOL domains are important to older patients in their decision-making about clinical management. And to characterize longitudinal health-related quality of life (QOL) for older adults with indolent lymphomas.
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A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (SubQSA)
Jacksonville, FL; Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.
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Circulating Tumor DNA (cTDNA) Based in NGS (Next Generation Sequencing) Assays for Oncology Patients With Solid Tumors
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of NGS assays using circulating tumor DNA for the detection of mutations associated solid tumors.
The performance characteristics of these assays for detecting ctDNA mutation in oncology patients will be assessed by comparing the mutation results obtained from these assays to those obtained by orthogonal methods, including tissue-based assays and results from a ctDNA assay by Guardant on blood.
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Targeted Imaging Of Melanoma For Alpha-Particle Radiotherapy
Rochester, MN
The purpose of this study is to determine safety and measure biodistribution of two imaging agents in patients with refractory or metastatic melanoma. This study will use [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) imaging.
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JAB-23E73 In Adult Participants With Advanced Solid Tumors With KRAS Alteration
Rochester, MN
This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors
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Trial Of Nadofaragene Firadenovec Vs. Observation In Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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Dose Optimization And Expansion Study Of DFV890 In Adult Patients With Myeloid Diseases
Rochester, MN
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), effiectiveness and recommended dose (RD) for single agent (SA) DFV890.
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A Prospective Ocular Tumor Study
Rochester, MN
The purpose of this study is to use clinical, imaging, molecular, and epidemiological investigation toward the goal of providing new knowledge about ocular tumors that will be useful in understanding, diagnosing, monitoring, and suggesting new avenues of treatment. This study does not involve experimental treatment of any ocular tumor, but rather observation of tumor natural history or outcomes following standard of care therapy, associated systemic and ocular conditions, and basic research investigations to better understand tumor biomarkers and pathophysiology.
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Study Of Retinfanlimab In Combination With INCAGN02385 And INCAGN02390 As First-Line Treatment In Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma Of The Head And Neck
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
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A Study Of PARG Inhibitor ETX-19477 In Patients With Advanced Solid Malignancies (ERADIC8)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.
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Ivosidenib In Participants With Locally Advanced Or Metastatic Conventional Chondrosarcoma Untreated Or Previously Treated With 1 Systemic Treatment Regimen
Jacksonville, FL; Rochester, MN
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades ...
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-130037 In Participants With Advanced Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.
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Surgical Drain Fluid For Detection Of Molecular Residual Disease (MRD) In Bladder, Renal And Urothelial Cancers
Rochester, MN
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with bladder, renal or urothelial cancer.
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A Study Of ART0380 For The Treatment Of Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
* Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan
* Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan
* Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
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Efficacy And Safety Study Of Tisotumab Vedotin For Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tisotumab vedotin is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur.
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A Study To Investigate LYL845 In Adults With Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
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Surgical Drain Fluid For Detection Of Molecular Residual Disease In Patients With Non-small Cell Lung Cancers
Rochester, MN
The purpose of this study is to characterize post-surgical drain fluid, pleural fluid, collected from the drainage device placed during surgery, as a biomarker for molecular residual disease in patients with non small cell lung cancer.
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CATALINA-2: A Clinical Study Of TORL-1-23 In Platinum-resistant Ovarian Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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Gleolan For Visualization Of Newly Diagnosed Or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
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A Phase 3 Study To Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy In Previously Treated Head And Neck Squamous Cell Carcinoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
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Safety And Tolerability Of TNG908 In Patients With MTAP-deleted Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first in human study in patients with deleted Methylthioadenosine phosphorylase (MTAP) advanced or metastatic solid tumors is to detertamine dose escalation in part one and dose expansion in specific MTAP-deleted tumor types.
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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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A Study Of Intravesical Enfortumab Vedotin For Treatment Of Patients With Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to test drug enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
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Two Studies For Patients With High Risk Prostate Cancer Testing Less Intense Treatment For Patients With A Low Gene Risk Score And Testing A More Intense Treatment For Patients With A High Gene Risk Score
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Rochester, MN
The puporse of this trial is to compare less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses ...
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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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Global Trial In APG2575 For Patients With CLL/SLL
Jacksonville, FL
The purpose of this study is to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors
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A Study To Evaluate Gleolan To Enhance Tumor Visualization In Patients With Newly-diagnosed Or Recurrent Meningioma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX).
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Study Of INBRX-109 In Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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A Study To Evaluate ALN-BCAT In Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
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A Study Of SPX-303, A Bispecific Antibody Targeting LILRB2 And PD-L1 In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
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Cancer screening practices of individuals with Lynch Syndrome
Rochester, MN
This is a survey study to describe how women with Lynch syndrome are being screened for gynecologic cancer risk, their perception of cancer risk, and uptake of risk reducing surgery.
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A Study To Explore Tumor Biology In Metastatic Esophageal And Gastric Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.
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Iberdomide, Daratumumab, Bortezomib, And Dexamethasone For Treatment Of Newly Diagnosed Multiple Myeloma, IDEAL Study
Rochester, MN
The purpose of this study is to find the maximum tolerated dose of iberdomide for patients newly diagnosed with multiple myeloma, and to determine response rate during induction treatment when combined with daratumumab, bortezomib and dexamethansone.
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A Randomized Phase 2 Trial Of Axitinib And TRC105 Versus Axitinib Alone In Patients With Advanced Or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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Phase 3 Study Of DCC-2618 Vs Placebo In Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Jacksonville, FL; Rochester, MN
This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo
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JSI-1187-01 Monotherapy And In Combination With Dabrafenib For Advanced Solid Tumors With MAPK Pathway Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
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Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations
Jacksonville, FL; Rochester, MN
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...
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A Study To Analyze The Safety And Effectiveness Of The NanoKnife® System In Unresectable Stage 3 Pancreatic Adenocarcinom Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System for the ablation of unresectable Stage 3 pancreatic adenocarcinoma (Stage 3 pancreatic cancer).
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Financial Toxicity Among Patients In Phase I Clinical Trials
Rochester, MN
As medical care in the United States becomes increasingly expensive, cost stewardship is a necessary component of delivering high value care. Cancer patients require additional protection from unmanageable costs, as the average out of pocket (OOP) cost during the first month of diagnosis is as high as $2900. Financial toxicity (FT) describes the adverse impact that the cost of treatment imposes upon our patients. Over the last five years, FT has become a well-recognized adverse impact of a cancer diagnosis. FT not only decreases the patient's quality of life, but also patients who file bankruptcy during cancer treatment ...
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Topical Cannabidiol (CBD) For The Treatment Of Chemotherapy-induced Peripheral Neuropathy
Albert Lea, MN; Mankato, MN; Rochester, MN
The primary purpose of this study is to evaluate whether topical CBD improves chemotherapy-induced peripheral neuropathy (CIPN), compared to placebo, and to evaluate side effects from topical CBD cream use, compared to placebo.
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A Study Of NT-175 In Adult Subjects With Unresectable, Advanced, And/or Metastatic Solid Tumors That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.
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Testing The Addition Of An Anti-Cancer Drug, Gemcitabine, To Usual Treatment (BCG Alone) In People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with ...
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A Study to Assess Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Rochester, MN
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. Note: The standard drug used for the ...
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Efficacy And Safety Of Tislelizumab In Combination With Fruquintinib In Participants With Selected Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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A Study of STRO-001 in Patients with Advanced B-Cell Malignancies
Jacksonville, FL
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and preliminary effectiveness of STRO-001 given intravenously every 2 weeks to patients with advanced b-cell malignancies.
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A Study to See if the Depth of Tumor Invasion of Esophageal Carcinoma Predicts Lymph Node Involvement and Cancer Free Survival
Rochester, MN
The purpose of this study is to see if different depths of submucosal tumor invasion in esophageal cancer can predict lymph node involvement and survival.
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A Study to Explore Cancer Patient Experiences and Their Decisions About Sharing Genetic Cancer Screening Information with Family Members
Rochester, MN
The purpose of this study is to characterize the beliefs and attitudes of cancer patients who received a positive result from a genetic cancer screen as part of the Mayo Clinic Intercept study (IRB#18-000326, PI: Samadder). This data will be collected using semi-structured, one-on-one interviews.
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A Study To Evaluate Personalized Molecular Marker And Immunoprofiling To Transform Hepatocellular Carcinoma Treatment
Jacksonville, FL
The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets. Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents (or combinations) with particular tumor profiles.
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A Study to Review the Safety of Familial Adenomatous Polyposis/Erlotinib Study
Scottsdale/Phoenix, AZ
The purpose of this study is to review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, who provide consent for the review of their medical records. There have been reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol. A review of literature found insufficient data to determine whether or not there is a longer term safety risk to the participant in MAY2016-07-01.
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Virtual Reality Intervention To Improve Psychological Symptom Burden For Cancer Patients Undergoing Treatment
Jacksonville, FL
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to ...
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The In4M Study: Integrating 4 Measures To Assess Physical Function In Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the measurement characteristics of these different sources of physical function data in a cancer population undergoing cytotoxic chemotherapy.
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A Tool For Improving The Shared Decision-making Process In Patients With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to use the shared decision-making (SDM) tool in clinical conversations to test whether these SDM tools affect patient understanding, treatment fidelity, or outcomes in patients with lung cancer.
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Comparing Rituximab And Mosunetuzumab Drug Treatments For People With Low Tumor Burden Follicular Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with ...
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A First-in-Human Study Of BG-C137, An Anti-FGFR2b Antibody Drug Conjugate, In Participants With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.
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A Study To Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT In Men With Hormone Sensitive Prostate Cancer And Raise Of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if darolutamide plus ADT given for 12 months improves rPFS by PSMA PET/CT compared with placebo plus ADT given for 12 months, and to further evaluate efficacy and to measure the treatment impact on patients’ quality of life, and to assess the safety of darolutamide plus ADT compared with placebo plus ADT.
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A Study To Evaluate Enfortumab Vedotin To Treat Metastatic Squamous Cell Carcinoma Of The Penis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to estimate the best response of enfortumab vedotin treatment for patients with metastatic squamous cell carcinoma of the penis (PSCC).
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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors In Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts In Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) And Pancreatic Adenocarcinoma (PDA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan or topotecan at different doses.
Irinotecan has already been approved by the FDA to treat pancreatic cancer while topotecan has already been approved by the FDA to treat small cell lung cancer.
Another purpose of the study is to check the level of the study drugs in your blood called pharmacokinetics or PK and to see if there are changes in levels of circulating tumor cells in your blood. To assess what effect the study ...
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A Study Of Unesbulin In Participants With Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory Leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.
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Study Of BMF-219, In Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), And Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy (Cohorts 1, 2, 3, and 4).
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Safety And Preliminary Efficacy Assessment Of AZD7789 In Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma
Rochester, MN
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
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Comparing Rituximab And Mosunetuzumab Drug Treatments For People With Low Tumor Burden Follicular Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with ...
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A First-in-Human Study Of BG-C137, An Anti-FGFR2b Antibody Drug Conjugate, In Participants With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.
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A Study To Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT In Men With Hormone Sensitive Prostate Cancer And Raise Of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if darolutamide plus ADT given for 12 months improves rPFS by PSMA PET/CT compared with placebo plus ADT given for 12 months, and to further evaluate efficacy and to measure the treatment impact on patients’ quality of life, and to assess the safety of darolutamide plus ADT compared with placebo plus ADT.
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A Study To Evaluate Enfortumab Vedotin To Treat Metastatic Squamous Cell Carcinoma Of The Penis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to estimate the best response of enfortumab vedotin treatment for patients with metastatic squamous cell carcinoma of the penis (PSCC).
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Neoadjuvant Dual Checkpoint Blockade With PD1 And LAG-3 Inhibition In Resectable Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is toassess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 1-49%, as measured by rate of major pathologic response (MPR) (defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 ≥50%, as measured by rate of major pathologic response (MPR).
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Outcomes Database To ProspectivelY ASSEss The Changing TherapY Landscape In Renal Cell Carcinoma (ODYSSEY RCC)
Rochester, MN
The purpose of this study is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.
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Study Of AB598 Monotherapy And Combination Therapy In Participants With Advanced Cancers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.
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Digital Biomarker And Omics-Based Assessment Of Surgical Resiliency In Children Undergoing Solid Tumor Resection
Rochester, MN
The purpose of this study is to demonstrate 1) feasibility of digital biomarker assessment using wearable in children with solid tumors who undergo surgery and 2) alterations in circulating proteins and metabolites indicative of a stressed state will persist postoperatively and correlate with clinical signs of recovery.
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A First-in-human Study Of 3HP-2827 In Patients With Unresectable Or Metastatic Solid Tumors With FGFR2 Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
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Lurbinectedin + Doxorubicin In Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma, and to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.
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Open-Label Study Of The CDK4/6 Inhibitor SPH4336 In Subjects With Locally Advanced Or Metastatic Liposarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).
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A Study Of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab In Previously Untreated Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
Rochester, MN
The purpose of this study is to assess whether minimal residual disease (MRD) driven finite calabrutinib plus venetoclax (AV) treatment is non-inferior to MRD-driven finiteenetoclax plus obinutuzumab (VO) treatment with respect to progression-free survival (PFS).
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Treatment Of Patients With Recurrent High-Grade Glioma With APG-157 And Bevacizumab
Rochester, MN
The purpose of this study is to assess the toxicity and effectiveness of bevacizumab with APG-157 for recurrent high grade glioma patients with disease progression after bevacizumab.
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Vaccine Therapy Plus Pembrolizumab In Treating Advanced Ovarian, Fallopian Tube, Or Primary Peritoneal Cavity Cancer (FRAPPE)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate to the combination of folate receptor alpha dendritic cells (FRaDCs) plus pembrolizumab in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors In Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts In Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) And Pancreatic Adenocarcinoma (PDA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan or topotecan at different doses.
Irinotecan has already been approved by the FDA to treat pancreatic cancer while topotecan has already been approved by the FDA to treat small cell lung cancer.
Another purpose of the study is to check the level of the study drugs in your blood called pharmacokinetics or PK and to see if there are changes in levels of circulating tumor cells in your blood. To assess what effect the study ...
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A Drug-drug Interaction Study Of Avapritinib And Midazolam To Treat Unresectable Or Metastatic Gastrointestinal Stromal Tumors And Other Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to investigate the effect of Avapritinib on the pharmacokinetics of Midazolam in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) or other advanced solid tumors.
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A Study To Evaluate Zanubrutinib To Treat Patients With B-cell Malignancies
Rochester, MN
The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.
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A Study To Assess Dynamic Changes In Plasma Proteome To Identify Early Detection And Treatment Response Biomarkers For HGSOC
Rochester, MN
This study aims to identify candidate High Grade Serous Cancer (HGSC) early detection and chemotherapy treatment response biomarkers. For the purpose of this study we define high grade serous cancers to include invasive cancers arising in the ovary and/or fallopian tubes (FT). Using mass spectrometry we will deeply profile and quantitate dynamic changes in the plasma proteome and N-gylcocapture sub-proteome that occur as a consequence of surgical debulking and platinum-based chemotherapy.
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A Study Of BH-30643 In Subjects With Locally Advanced Or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.
Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the ...
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KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models
Rochester, MN
This study will assess the ability of the Pathos platform to predict which patients will respond to certain colorectal cancer drug treatments. To demonstrate that for patients with advanced colorectal cancer, prediction scores based on in vitro tumor organoid drug response are positively associated with the rate of first line response.
To demonstrate that for patients with advanced colorectal cancer, prediction scores based on in vitro tumor organoid drug response are positively associated with progression free survival.
To demonstrate that for patients with advanced colorectal cancer who meet the endpoint of first line response, prediction scores ...
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Study Of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
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Efficacy And Safety Of Nemtabrutinib (MK-1026) In Participants With Hematologic Malignancies (MK-1026-003)
Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
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Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Rochester, MN
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial will determine whether systematically assessing patient reported outcomes for sleep disturbance, pain, anxiety, depression, and fatigue among patients with solid and liquid malignancies and using these data to increase the frequency of guideline-concordant care by: 1) reporting these data to their clinical teams, 2) providing patients with needs-matched symptom self-management education, and 3) suggesting evidence-based symptom management strategies to their care teams improves patients' quality of life, symptoms, and adherence to cancer treatment, while reducing their unplanned use of healthcare resources.
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A Study Of X4P-001 In Patients With Advanced Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the study is to test different doses of X4P-001 given alone and in combination with axitinib in patients diagnosed with advanced renal cell carcinoma. The goals of the study are to determine the safety and tolerability of X4P-001, as well as the potential effect it may have on the body and the cancer tumor.
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A Study Of SC-007 In Subjects With Advanced Cancer
Rochester, MN
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
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Clinical Study Of Oral CMET Inhibitor INC280 In Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer
Rochester, MN
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
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Study Of DCC-3014 In Patients With Advanced Tumors And Tenosynovial Giant Cell Tumor
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of DCC-3014 in patients with solid tumors including, but not limited to, prostate, breast, gastric, ovarian, and non-small cell lung cancer, as well as tumor types with high macrophage content or high expression of CSF-1 such as tenosynovial giant cell tumor. There will be an Escalation Phase and an Expansion Phase in this study.
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Daratumumab For Chemotherapy-Refractory Minimal Residual Disease In T Cell ALL
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the rate of complete MRD response by flow cytometry after 4 weekly doses of daratumumab-hyaluronidase (Day 29) among patients with MRD positive T-ALL in hematologic morphologic complete remission or complete remission with incomplete hematologic recovery. The secondary objectives include; evaluation of morphologic relapse free survival (RFS), evaluation of overall survival (OS), assessment of the the survival outcomes in patients that undergo allogeneic stem cell transplant after complete MRD response with daratumumab-hyaluronidase, assessment of adverse effects and tolerability of daratumumab-hyaluronidase in T-ALL, and assessment of flow cytometry based MRD status on Day 64 of ...
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Study To Evaluate The Efficacy And Safety Of Ersodetug In Patients With Inadequately Controlled Hypoglycemia Due To Tumor-Associated Hyperinsulinism
Rochester, MN
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in participants with inadequately controlled hypoglycemia due to islet-cell (insulinomas) and non-islet cell tumor hyperinsulinism.
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Sequential Treatments Or Combinations Including Dasatinib, Quercetin, Fisetin And/or Temozolomide For The Treatment Of Previously Treated Glioma With Residual Disease
Rochester, MN
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They ...
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Study Of Lurbinectedin In Combination With Doxorubicin Versus Doxorubicin Alone As First-line Treatment In Participants With Metastatic Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
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A Trial To Find Out If REGN5678 Is Safe And How Well It Works Alone Or In Combination With Cemiplimab For Adult Participants With Metastatic Castration-Resistant Prostate Cancer And Other Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.
This study is looking at ...
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Study Of Datopotamab Deruxtecan Plus Carboplatin Or Cisplatin Versus Gemcitabine Plus Carboplatin Or Cisplatin In Participants With Locally Advanced Or Metastatic Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
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Care Processes And Person Centered Care Of Patients With Neuroendocrine Tumors
Rochester, MN
Given that neuroendocrine tumors (NETs) represent a rare condition with complex treatment decisions and a lack of concrete guidance for physicians, shared-decision making (SDM) is particularly challenging.In an effort to improve PCC, we hope to identify care processes throughout the clinical encounter that are important to patients. Identifying these processes would allow for standardization of the care environment without focusing on specific provider characteristics. As such, changes to the institutional and system-level processes could be made in more actionable and systematic ways.
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A Study To Analyze Symptoms And Quality Of Life Issues In Women Living With Metastatic Breast Cancer
Jacksonville, FL
The purpose of this study is to gain an understanding of the lived experiences of symptoms and quality of life issues experienced by women with metastatic breast cancer.
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A Phase 3, Randomized, Open-label, Controlled Study Comparing The Efficacy And Safety Of Zanidatamab To Trastuzumab, Each In Combination With Physician’s Choice Chemotherapy, For The Treatment Of Participants With Metastatic HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy.
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Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy Or Plus Camizestrant In HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, Or PALB2m Advanced Breast Cancer
Jacksonville, FL; Rochester, MN
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.
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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Jacksonville, FL
UP-NEXT is a double-blind, randomized, placebo controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion for patients once every four weeks. Patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer expressing high levels of NaPi2b.
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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, FL; Scottsdale/Phoenix, AZ
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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Dose Escalation Study of mRNA 2416 for Intratumoral Injection to Patients With Advanced Malignancies
Scottsdale/Phoenix, AZ
This clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA 2416 in patients with relapsed/refractory solid tumor malignancies or lymphoma
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Study To Test The Safety And Tolerability Of PF-07257876 In Participants With Selected Advanced Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this FIH study is to assess the safety and tolerability, effectiveness, pharnacokinetcs (PK), and pharmacodynamics (PD) of increasing dose levels of PF-07257876; to identify the MTD and potential RP2D of PF-07257876; and to select the RP2D for further studies in development. This study will enroll patients with advanced cancers with no curative therapy (NSCLC, SCCHN, and OvCa) whose tumors have either failed prior PD-1 or PD-L1 therapies (NSCLC or SCCHN); or platinum-based chemotherapy (OvCa). In addition, patients’ tumors must have demonstrated PD-L1 expression > 1%.
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Study Of DS-1062a In Advanced Or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, pharmacokinetics (PK), and safety of DS-1062a in subjects with advanced or metastatic NSCLC with known actionable genomic alterations (i.e., alterations in genes with approved therapies, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, and RET) and that has progressed on or after 1 or more kinase inhibitors and platinum-based chemotherapy.
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Testing Teclistamab (TECVAYLI) In Combination With Iberdomide For Hard-to-Treat Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating hard-to-treat multiple myeloma. Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, ...
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Melanoma In-transit Tissue Bank And Molecular Analysis For Personalized Therapies
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy. Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.
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A Qualitative Study of Mayo Clinic Calabresi Scholars and Former Scholars
Rochester, MN
To learn from scholars and former scholars of the Mayo Clinic Cancer Center’s “Paul Calabresi Clinical Oncology (K12) Training Program” in their own words what helped them and what did not help them from a career development standpoint.
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Phase 3 Study Of Taletrectinib Vs Placebo As An Adjuvant Therapy In ROS1 Positive NSCLC (TRUST-IV)
Rochester, MN
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
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GB5121 In Adult Subjects With Relapsed/Refractory CNS Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, is to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.
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A Study Of LSTA1 When Added To Standard Of Care Versus Standard Of Care Alone In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test a new drug plus standard treatment compared with standard treatment alone in patients with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and cholangiocarcinoma. The main questions it aims to answer are: -is the new drug plus standard treatment safe and tolerable -is the new drug plus standard treatment more effective than standard treatment.
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A Study To Assess Metabolic Changes In The Blood With Standard Treatment In Patients With Gliomas
Rochester, MN
The purpose of this study is to generate preliminary data on the impact of standard, first line treatment on the plasma metabolome of patients with a new diagnosis of glioma.
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Molecular Analysis To Drive Individualized Care In Lung Cancer
Rochester, MN
The purpose of this study is to determine if robotic biopsies provide sufficient material for whole genomics and transcriptomics, transcriptome anomalies are confined to tumor cells as opposed to background lung parenchyma, and whole genomics may provide further pathologic insight in cases where de novo primary may be difficult to discern from metastatic disease.
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A Study To Evaluate The Safety, Effectiveness And Tolerability Of APG-2575 In Patients With Waldenström Macroglobulinemia
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-2575, alone or in combination with other therapeutic agents (ibrutinib or rituximab), in patients with Waldenström Macroglobulinemia (WM).
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In Vitro 3D Cell Culture Models Validation For Tumor Drug Sensitivity After Tissue Removal
Rochester, MN
The purpose of this study is to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
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A Study Of The Pan-KRAS Inhibitor LY4066434 In Participants With KRAS Mutant Solid Tumors
Scottsdale/Phoenix, AZ
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
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Phase Ib Study Of Select Drug Combinations In Patients With Lower Risk MDS
Rochester, MN
The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndrome (MDS).
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Efficacy Of Daromun Neoadjuvant Intratumoral Treatment In Clinical Stage IIIB/C Melanoma Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
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Study To Improve Health-related Quality Of Life (HRQOL) In Black Prostate Cancer Patients (CaPQoL) Through Whole Person Survivorship Care
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.
Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, ...
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Using Social Media For Public Health Education On Melanoma Within The Hispanic Population
Scottsdale/Phoenix, AZ
The purpose of this study is to develop online education video-based modules to educate the Hispanic community. This will allow for the widespread, cost-effective scaling of our educational platform. Also, to demonstrate improvement in knowledge and practice of sun-smart behaviors. We will achieve this goal through a baseline, three-month, and one-year follow-up questionnaire examining melanoma knowledge and sun-safe behaviors (sunscreen use, sun protective clothing use, self-skin examination). Understanding the risks of melanoma and actively reducing one's risk of melanoma will be key to reducing the incidence of melanoma and improving overall survival in this population.
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Pragmatic Comparative Clinical Trial To Determine Optimal Initial Therapy For Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed Multiple Myeloma.
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A Study Of A New Way To Treat Children And Young Adults With A Brain Tumor Called NGGCT
Rochester, MN
The purpose of this study is to monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. Also, to improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.
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A Study To Assess LXH254 In Patients With Previously Treated Unresectable Or Metastatic BRAFV600 Or NRAS Mutant Melanoma
Rochester, MN
The purpose of this study is to evaluate combinations, using LXH254 as a backbone, which may help overcome intrinsic and acquired resistance to BRAF targeted therapy as well as offer new treatment options for NRAS melanoma patients.
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Study Of RAS(ON) Inhibitors In Patients With Gastrointestinal Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The first three subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
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A Study To Determine The Effectiveness And Safety Of Luspatercept In Patients With Myelodysplastic/ Myeloproliferative Neoplasms With Ring Sideroblasts And Thrombocytosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to document the erythroid response rate assessed as per the 2015 International Working Group (IWG) MDS/MPN response criteria.
In this study we want to find out more about the side effects of a new drug combination for MDS/MPN-RS-T and MDS/MPN-U with RS, luspatercept with or without hydroxyurea and what doses of this combination are safe for people to take and how the disease responds to the treatment. There are 2 groups of patients being studied in this trial. One group of patients will receive luspatercept. The other group will receive luspatercept and hydroxyurea. ...
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Alisertib in Treating Young Patients with Recurrent or Refractory Solid Tumors or Leukemia
No Locations
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)
Rochester, MN
The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
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A Study of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to
- Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
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A Study Of Personalized Molecular Markers To Transform Treatment Of High Grade Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize a landscape of DNA alterations, RNA transcripts, and microbiome changes in resected tumors and body fluids of patients that have been diagnosed with aggressive endometrial cancer (Grade 3 and Type II) in order to identify molecular targets for which therapeutic drugs may exist.
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Female Patients And Female Partners Of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment Of HPV Associated Anogenital Pathology
Rochester, MN
The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.
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A Study To Evaluate TAK-981 Given With Monoclonal Antibodies In Adults With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to evaluate the safety and effectiveness of TAK-981 in combination with anti-CD38 monoclonal antibodies. TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies to treat participants who have relapsed or refractory multiple myeloma.
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Colorectal Cancer And Peripheral Neuropathy Study
Jacksonville, FL
The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.
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Evaluate REC-4881 In Patients With FAP (TUPELO)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to designed to characterize the safety, tolerability, PK, PD, and preliminary activity of REC-4881 administered orally (PO) at multiple doses on a once daily schedule in participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
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A Master Protocol To Evaluate The Long-Term Safety Of (LY3527727) Pirtobrutinib
Rochester, MN
The purpose of this study is to evaluate the long-term safety of pirtobrutinib.
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A Dose Finding And Safety Study Of CC-220, Alone And In Combination With An Anti-CD20 Monoclonal Antibody (MAb) In Subjects With Relapsed Or Refractory Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).
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Efficacy And Safety Of COVID-19 Vaccine In Cancer Patients
Jacksonville, FL
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
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Tebentafusp Regimen Versus Investigator's Choice In Previously Treated Advanced Melanoma (TEBE-AM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1) vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma.
-
A Study To Evaluate ARV-806 In Adults With Advanced Cancer That Has The KRAS G12D Mutation
Scottsdale/Phoenix, AZ
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.
Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is ...
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A Study Of ELI-002 7P In Subjects With KRAS/NRAS Mutated Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
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A Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Fruquintinib In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
-
A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
-
Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
-
Lutetium 177Lu-Edotreotide Versus Best Standard Of Care In Well-differentiated Aggressive Grade-2 And Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
-
A Trial Of Casdozokitug In Combination With Toripalimab Plus Bevacizumab In Participants With Unresectable And/or Locally Advanced Or Metastatic Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.
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Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
No Locations
The purpose of this study is:
- To assess whether a team based care model applied to distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
- To assess whether health promotion tools such as psychoeducation applied to non-distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
-
Immune Response To Antigens
Jacksonville, FL
The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.
-
Utility Of Gallium-68-DOTA-Octreotat PET/CT In The Characterization Of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
-
Investigating Magnesium Glycinate In Structure/Function Role Of Hot Flashes.
Jacksonville, FL
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
-
A Study To Provide Expanded Access For The Treatment Of Cancers With Rearranged During Transfection (RET) Activation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
-
Study Of The Safety, Pharmacokinetics And Efficacy Of EDO-S101, In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
-
A First-in-Human Study Of MEN2312 In Adults With Advanced Breast Cancer
Rochester, MN
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
-
Methylene Blue Mouthwash For Oral Mucositis Pain In Cancer
Rochester, MN
Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.
Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.
-
Study To Evaluate The Safety And Effectiveness Of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes In Women With Breast Cancer Using Magseed Markers As An Alternative To The Current Practice Of Placing Radioactive Seed Markers
Rochester, MN
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
-
Lasofoxifene And Abemaciclib To The Combination Of Fulvestrant And Abemaciclib For Locally Advanced Or Metastatic ER+/HER2− Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the PFS of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer with an ESRl mutation.
-
Preclinical drug testing and assay development for lung adenocarcinoma characterized by the expression of ASCL1
Rochester, MN
The purpose of this study is to perform preclinical testing in patient samples and experimental models.
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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or ...
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Pafolacianine For Localization Of Pediatric Extracranial Solid Tumors
Rochester, MN
The purpose of this study is to determine the utility of NIR fluorescent imaging using the molecular imaging agent CYTALUX for identifying lesions in children and adolescent patients with primary or metastatic solid tumors.
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IFX_HU2.0 As An Adjunctive Therapy To Pembrolixumab In Checkpoint Inhibitor Naive Subjects With Advanced Or Metastatic Merkel Cell Carcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) between subjects treated with intralesional administration of IFx-Hu2.0, as an adjunctive therapy, followed by pembrolizumab, and subjects treated with placebo followed by pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Melanoma Care Barriers In United States Latinx Population
Scottsdale/Phoenix, AZ
The purpose of this study is to provide qualitative analysis of barriers to melanoma care in the United States Latinx Population.
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Cancer Distress
Rochester, MN
The purpose of this study is to explore patient feedback regarding how physician behaviors influence their distress level.
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A Study Of ABBV-383 With Relapsed Refractory Waldenström Macroglobulinemia
Rochester, MN
The purpose of this study is to determine the safety, maximum tolerated dose (MTD) and RP2D of ABBV-383 monotherapy for patients with RRWM and to determine VGPR or deeper response as the best response achieved with ABBV 383 within 12 cycles of initiation of therapy for patients with RRWM.
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Molecular Analysis To Drive Individualized Care In Lung Cancer
Rochester, MN
The purpose of this study is to determine if robotic biopsies provide sufficient material for whole genomics and transcriptomics, transcriptome anomalies are confined to tumor cells as opposed to background lung parenchyma, and whole genomics may provide further pathologic insight in cases where de novo primary may be difficult to discern from metastatic disease.
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A Study To Evaluate The Safety, Effectiveness And Tolerability Of APG-2575 In Patients With Waldenström Macroglobulinemia
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-2575, alone or in combination with other therapeutic agents (ibrutinib or rituximab), in patients with Waldenström Macroglobulinemia (WM).
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A Study Of The Pan-KRAS Inhibitor LY4066434 In Participants With KRAS Mutant Solid Tumors
Scottsdale/Phoenix, AZ
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
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Phase Ib Study Of Select Drug Combinations In Patients With Lower Risk MDS
Rochester, MN
The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) Myelodysplastic Syndrome (MDS).
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Efficacy Of Daromun Neoadjuvant Intratumoral Treatment In Clinical Stage IIIB/C Melanoma Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
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Study To Improve Health-related Quality Of Life (HRQOL) In Black Prostate Cancer Patients (CaPQoL) Through Whole Person Survivorship Care
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.
Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, ...
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Using Social Media For Public Health Education On Melanoma Within The Hispanic Population
Scottsdale/Phoenix, AZ
The purpose of this study is to develop online education video-based modules to educate the Hispanic community. This will allow for the widespread, cost-effective scaling of our educational platform. Also, to demonstrate improvement in knowledge and practice of sun-smart behaviors. We will achieve this goal through a baseline, three-month, and one-year follow-up questionnaire examining melanoma knowledge and sun-safe behaviors (sunscreen use, sun protective clothing use, self-skin examination). Understanding the risks of melanoma and actively reducing one's risk of melanoma will be key to reducing the incidence of melanoma and improving overall survival in this population.
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Pragmatic Comparative Clinical Trial To Determine Optimal Initial Therapy For Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed Multiple Myeloma.
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In Vitro 3D Cell Culture Models Validation For Tumor Drug Sensitivity After Tissue Removal
Rochester, MN
The purpose of this study is to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
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A Study To Assess LXH254 In Patients With Previously Treated Unresectable Or Metastatic BRAFV600 Or NRAS Mutant Melanoma
Rochester, MN
The purpose of this study is to evaluate combinations, using LXH254 as a backbone, which may help overcome intrinsic and acquired resistance to BRAF targeted therapy as well as offer new treatment options for NRAS melanoma patients.
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Study Of RAS(ON) Inhibitors In Patients With Gastrointestinal Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The first three subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
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A Study To Determine The Effectiveness And Safety Of Luspatercept In Patients With Myelodysplastic/ Myeloproliferative Neoplasms With Ring Sideroblasts And Thrombocytosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to document the erythroid response rate assessed as per the 2015 International Working Group (IWG) MDS/MPN response criteria.
In this study we want to find out more about the side effects of a new drug combination for MDS/MPN-RS-T and MDS/MPN-U with RS, luspatercept with or without hydroxyurea and what doses of this combination are safe for people to take and how the disease responds to the treatment. There are 2 groups of patients being studied in this trial. One group of patients will receive luspatercept. The other group will receive luspatercept and hydroxyurea. ...
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Alisertib in Treating Young Patients with Recurrent or Refractory Solid Tumors or Leukemia
No Locations
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)
Rochester, MN
The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
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A Study of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to
- Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
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A Study Of Personalized Molecular Markers To Transform Treatment Of High Grade Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize a landscape of DNA alterations, RNA transcripts, and microbiome changes in resected tumors and body fluids of patients that have been diagnosed with aggressive endometrial cancer (Grade 3 and Type II) in order to identify molecular targets for which therapeutic drugs may exist.
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Female Patients And Female Partners Of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment Of HPV Associated Anogenital Pathology
Rochester, MN
The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.
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Tebentafusp Regimen Versus Investigator's Choice In Previously Treated Advanced Melanoma (TEBE-AM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1) vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma.
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A Study To Evaluate TAK-981 Given With Monoclonal Antibodies In Adults With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to evaluate the safety and effectiveness of TAK-981 in combination with anti-CD38 monoclonal antibodies. TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies to treat participants who have relapsed or refractory multiple myeloma.
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Colorectal Cancer And Peripheral Neuropathy Study
Jacksonville, FL
The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.
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Evaluate REC-4881 In Patients With FAP (TUPELO)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to designed to characterize the safety, tolerability, PK, PD, and preliminary activity of REC-4881 administered orally (PO) at multiple doses on a once daily schedule in participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
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A Master Protocol To Evaluate The Long-Term Safety Of (LY3527727) Pirtobrutinib
Rochester, MN
The purpose of this study is to evaluate the long-term safety of pirtobrutinib.
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A Dose Finding And Safety Study Of CC-220, Alone And In Combination With An Anti-CD20 Monoclonal Antibody (MAb) In Subjects With Relapsed Or Refractory Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).
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Efficacy And Safety Of COVID-19 Vaccine In Cancer Patients
Jacksonville, FL
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
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A Study To Evaluate ARV-806 In Adults With Advanced Cancer That Has The KRAS G12D Mutation
Scottsdale/Phoenix, AZ
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.
Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is ...
-
A Study Of ELI-002 7P In Subjects With KRAS/NRAS Mutated Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
-
A Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Fruquintinib In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
-
A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
-
Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
-
Lutetium 177Lu-Edotreotide Versus Best Standard Of Care In Well-differentiated Aggressive Grade-2 And Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
-
A Trial Of Casdozokitug In Combination With Toripalimab Plus Bevacizumab In Participants With Unresectable And/or Locally Advanced Or Metastatic Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.
-
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
No Locations
The purpose of this study is:
- To assess whether a team based care model applied to distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
- To assess whether health promotion tools such as psychoeducation applied to non-distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
-
A First-in-Human Study Of MEN2312 In Adults With Advanced Breast Cancer
Rochester, MN
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
-
Immune Response To Antigens
Jacksonville, FL
The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.
-
Utility Of Gallium-68-DOTA-Octreotat PET/CT In The Characterization Of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
-
Investigating Magnesium Glycinate In Structure/Function Role Of Hot Flashes.
Jacksonville, FL
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
-
Study Of The Safety, Pharmacokinetics And Efficacy Of EDO-S101, In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
-
Methylene Blue Mouthwash For Oral Mucositis Pain In Cancer
Rochester, MN
Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.
Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.
-
A Study To Provide Expanded Access For The Treatment Of Cancers With Rearranged During Transfection (RET) Activation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
-
Lasofoxifene And Abemaciclib To The Combination Of Fulvestrant And Abemaciclib For Locally Advanced Or Metastatic ER+/HER2− Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the PFS of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer with an ESRl mutation.
-
Study To Evaluate The Safety And Effectiveness Of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes In Women With Breast Cancer Using Magseed Markers As An Alternative To The Current Practice Of Placing Radioactive Seed Markers
Rochester, MN
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
-
A Study To Evaluate KIN-3248 In Participants With Advanced Tumors Harboring FGFR2 And//or FGFR3 Gene Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
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Valemetostat Tosylate (DS-3201b), An Enhancer Of Zeste Homolog (EZH) 1/2 Dual Inhibitor, For Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Rochester, MN
The purpose of this study is to characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
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Study Of XmAb®819 In Subjects With Advanced Clear Cell Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
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Study Of Vorasidenib (AG-881) In Participants With Residual Or Recurrent Grade 2 Glioma With An IDH1 Or IDH2 Mutation (INDIGO)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization.
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A Phase 1 Study Of Voruciclib In Subjects With B-Cell Malignancies Or AML
Rochester, MN
The purpose of this study is to determine the safety and preliminary efficacy of voruciclib as monotherapy in subjects with relapsed or refractory B-cell malignancies or AML, and in combination with venetoclax in subjects with relapsed or refractory AML after treatment with standard therapy.
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A Study To Evaluate The Safety And Effectiveness Of TT-00420 In Adults With Advanced Cholangiocarcinoma
Rochester, MN
The purpose of this trial is to evaluate the effectiveness and safety of TT-00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment and discontinued due to disease progression, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab And A Combined Regimen Of Mosunetuzumab And Venetoclax In Participants With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Rochester, MN
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) ...
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A Study Evaluating Atezolizumab And Bevacizumab, With Or Without Tiragolumab, In Participants With Untreated Locally Advanced Or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
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Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records
Rochester, MN
The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.
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International Hepatobiliary Neoplasia Registry and Biorepository
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
This study is being done to:
1. Create a registry of patients having or at risk for cancer of the liver or bile ducts (also known as hepatocellular carcinoma or cholangiocarcinoma), or gallbladder cancer, and those individuals who have normal risk factors in order to improve the ability to diagnose and treat these cancers. We will use information in the medical record in this registry including how far advanced the cancer is (stage) and what treatments are used to treat the cancer.
2. A second purpose of this study is to obtain blood and tissue samples from participants ...
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A Study To Assess The Effectiveness And Safety Of Monalizumab Plus Cetuximab Compared To Placebo Plus Cetuximab In Recurrent Or Metastatic Head And Neck Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.
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A Digital Treatment Platform For The Delivery Of Home-Based Sequential Therapy In Patients With Glioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while ...
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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PLX038 For The Treatment Of Metastatic Ovarian, Peritoneal, And Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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A Comprehensive Translational Research Platform For Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or ...
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Interviews About Social Determinants Of Health In Southeast Asian Americans To Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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A Study To Analyze The Association Between Financial And Health Insurance Literacy And Financial Distress In Patients Being Treated For Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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CJNJ-67652000 And Prednisone For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer And SPOP Gene Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response ...
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Phase 2 Study Of VGT-309 In Lung Cancer
Rochester, MN
The purpose of this study is to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
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A Study Of CLN-619 (Anti-MICA/MICB Antibody) In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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SX-682 Treatment In Subjects With Myelodysplastic Syndrome Who Had Disease Progression Or Are Intolerant To Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Ulixertinib In People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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MC240508: Genomic Surveillance Of Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to ...
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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Investigating Memory And Physical Activity After Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to examine associations between physical activity and cognition in survivors of adolescent or young adult (AYA) cancers, and enhance understanding of physical activity behaviors, preferences, barriers, facilitators, and outcome expectancies in AYA survivors.
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Phase 1a/1b Study Of Aplitabart (IGM-8444) Alone Or In Combination In Participants With Relapsed, Refractory, Or Newly Diagnosed Cancers
Scottsdale/Phoenix, AZ
The purpose of this first-in-human study is to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of Aplitabart (IGM-8444) +FOLFIRI (± bevacizumab).
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NBTXR3 With Or Without Cetuximab LA-HNSCC
Jacksonville, FL
The purpose of this study is to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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Profiling Of Lung Cancer For Identification Of Treatment Targets And Strategies
Jacksonville, FL
The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.
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Study Assessing Activity Of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies In Adult Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma.
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A Study Of Oral LOXO-305 In Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Or Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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A Study Of MK-1026 In Patients With Selected Hematologic Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery
Rochester, MN
This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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A Colon Bank for Early Detection of Colon Cancer
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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Phase I/II Study Of The Combination Of Blinatumomab And Asciminib In Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
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A Study To Assess The Adverse Events And Change In Disease Activity In Adult Participants With Relapsed Or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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A Study To Assess Financial Burden And Its Impact On Quality Of Life In Patients With Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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A Safety Study Of SEA-TGT (SGN-TGT) In Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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Biomarkers To Predict For And Monitor Response To PD-1/PD-L1 Inhibitors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.
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A Trial Of TTI-621 For Patients With Hematologic Malignancies And Selected Solid Tumors
Jacksonville, FL; Rochester, MN
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy In Patients With Advanced Cutaneous Melanoma Or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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HeadStart4: Newly Diagnosed Children (<10 Y/o) With Medulloblastoma And Other CNS Embryonal Tumors
Rochester, MN
The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a ...
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A Phase 1 Study Of The Safety And Tolerability Of MT-125 In GBM Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.
Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to ...
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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A Study Of Ziftomenib, An Oral Menin Inhibitor, In Combination With Imatinib In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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Onvansertib For The Treatment Of Recurrent Or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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A Trial To Assess Effectiveness And Safety Of Octreotide Subcutaneous Depot In Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML).
The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the ...
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A Study To Evaluate Feasibility Of In Vivo Sensitivity Screen Using Direct Tumor Microinjection And FDG-PET In Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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Testing An Active Form Of Tamoxifen (4-hydroxytamoxifen) Delivered Through The Breast Skin To Control Ductal Carcinoma In Situ (DCIS) Of The Breast
No Locations
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
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Shared Decision-Making Encounter Tool For Decisions Of Adjuvant Treatment In Patients With Resected Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected Non-Small Cell Lung Cancer.
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ICCaRE Consortium Pilot Project 1: Feasibility Of A Point Of Prostate Cancer Diagnosis Intervention For Newly Diagnosed Black Men
Jacksonville, FL
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
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Perceived Financial Hardship In Patients With Multiple Myeloma And Their Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to examine the agrrement in perception of finacial hardship (FH) and the perceived stress in patients with multiple myeloma (MM) and their caregivers (CG). Additionally, we will describe protective buffering/emotional disclosure in patients with MM and their CGs and examine their association with FH, and perceived stress.
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A Study To Determine Baseline Levels For Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment
Rochester, MN
The purposes of this study are to determine the levels of prostate cancer-derived extracellular vesicles pre- and post-local therapy (radical prostatectomy or radiation therapy), to correlate analysis for PSA levels and prostate cancer-derived extracellular vesicles, and to determine baseline levels of prostate cancer-derived extracellular vesicles in patients undergoing different lines of primary local treatment.
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A Phase 1B/2 Study Of RP1 In Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients.
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A Study To Assess The Safety And Tolerability Of CFT8634 In Locally Advanced Or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma And SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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A Phase I/II Study To Evaluate AZD5851 In GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
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Rem-422, An MYB MRNA Degrader, In Patients With Relapsed/Refractory AML Or Higher-Risk MDS
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of REM-422 in patients with relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes.
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A Phase 1/2a Study Of IMM-1-104 In Participants With Previously Treated, RAS-Mutant, Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy in participants with RAS-mutated advanced or metastatic solid tumors.
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A Study Evaluating The Efficacy And Safety Of Cevostamab In Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma (CAMMA 2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).
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Evaluating Intraoperative Indocyanine Green Dye Fluorescence Angiography For Sarcoma Resectiong
Rochester, MN
The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.
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Phase 2 Study To Evaluate Safety And Efficacy Of Cretostimogene Grenadenorepvec In NMIBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer
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A Phase 1 Study Of XL309 (ISM3091) Alone And In Combination In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.
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Study To Evaluate The Efficacy And Safety Of BGB-11417 In Participants With Waldenström's Macroglobulinemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
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Pilot Study Of Antineoplastic
Rochester, MN
The purpose of this study is to use therapeutic drug monitoring (trough plasma concentrations of dabrafenib, hydroxy dabrafenib, and/or trametinib) along with CYP3A4/CYP3A5 and CYP2C8 genotyping and BRAF mutation quantification will correlate with effectiveness (based on imaging studies) and/or toxicity (pyrexia, liver dysfunction, rash) in known melanoma patients.
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A Dose-Escalation And Expansion Study Of BGB-16673 In Participants With B-Cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
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Phase 1/2 Study Of MRTX1719 In Solid Tumors With MTAP Deletion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.
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Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
Rochester, MN
The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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ADG126 In Combination With Pembrolizumab In Patients With Advanced/Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN
This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.
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A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia
Rochester, MN
AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients ...
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Solid Tumor Monoclonal B-cell Lymphocytosis Screening
Rochester, MN
The purpose of this study is to determine whether monoclonal B-cell lymphocytosis (MBL) has an impact on clinical outcomes among patients with a diagnosis of a solid tumor.
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Phase 3 Study Of Daraxonrasib (RMC-6236) In Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
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Pancreatic Cancer Detection Consortium
Rochester, MN
The purpose of this study is to develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at high-risk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts. Additionally to follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes and to make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.
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Ketoconazole In Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Rochester, MN
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
We would like to see if use of topical ketoconazole will improve rashes in patients with EGFR inhibitor-induced rash.
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Study Of Biomarker-Based Treatment Of Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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Dose-Escalation Study Of Cevostamab (BFCR4350A) In Participants With Relapsed Or Refractory Multiple Myeloma (R/R MM)
Scottsdale/Phoenix, AZ
This is a phase I, multicenter, open-label, dose-escalation study of cevostamab (BFCR4350A) administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).
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CC-220-MM-001: A Phase 1b/2a Multicenter, Open-Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Assess The Safety, Tolerability, Pharmacokinetics And Efficacy Of CC-220 As Monotherapy And In Combination With Other Treatments In Subjects With Multiple Myeloma
Scottsdale/Phoenix, AZ
This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT) and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
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A Study Of APG-2575 Alone Or In Combination With Other Therapeutic Agents To Treat Relapsed And/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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A Study Of WVT078 In Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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A Study Of Effect Of Different Biochemical Markers Including Leptin And Spexin In Children Before And After Having Hypothalamus Surgery
Rochester, MN
The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.
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A Study To Evaluate The Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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Iodine I-131 With Or Without Selumetinib In Treating Patients With Recurrent Or Metastatic Thyroid Cancer
Rochester, MN
This randomized phase II trial studies how well iodine I-131works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Because of this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose ...
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Testing The Effects Of Novel Therapeutics For Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a ...
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Study Using Chromogranin A As Surveillance Biomarker In Patients With CARcinoids
Rochester, MN
The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).
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A Study To Evaluate The Safety And Effectiveness Of AB928-Based Treatment Combinations To Treat Patients With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the clinical activity, safety and tolerability of etruma-based treatment combinations.
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A Study To Evaluate The Adverse Events, And Efficacy Of Intravenous (IV) Of Telisotuzumab Adizutecan In Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and ...
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Study Of The Theranostic Pair RYZ811 (Diagnostic) And RYZ801 (Therapeutic) To Identify And Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
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The Young Women's Breast Cancer Study
Rochester, MN
The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of at least 10 years following diagnosis). The study investigates short and long-term disease and treatment ...
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A Study Of TAS-120 In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
Rochester, MN
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
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A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
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A Study to Develop and Validate a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma
Rochester, MN
The purpose of this study is to develop and validate a new disease-specific, quality-of-life (QOL) index for sporadic Vestibular Schwannoma (VS) that addresses key shortcomings of previous instruments.
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Understanding Treatment Preferences In Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this research is to understand how people with lymphoma make decisions about treatment and why. Study participation involves partaking in one virtual focus group session with a group of up to 8 people with lymphoma and up to two group moderators. Participants will be asked questions about what they prefer in a lymphoma treatment and how they have made decisions on treatment of their lymphoma in the past. Questions may be about past experiences as well as future hypothetical situations. We hope that what we learn from these discussions will help us to improve care for people ...
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University Of California Minority Patient-Derived Xenograft (PDX) Development And Trial Center (UCaMP) To Reduce Cancer Health Disparities
Jacksonville, FL
The purpose of this study is to establish at least 200 patient-derived cancer xenografts (PDXs), and to utilize these PDXs in preclinical testing of single agents and drug combinations to guide precision cancer medicine decision-making with a focus upon the predominant racial/ethnic minority populations residing in California.
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Breath Condensate Of Lung Cancer Patients And Healthy Controls To Measure RNA Species In Exhaled Breath Condensate
Rochester, MN
The purpose of this study is to develop tests for early detection of lung cancer or lung fibrosis based on multiomics analyses of patients’ breath condensates.
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Patient Perspectives On Bladder Cancer Care
Jacksonville, FL; Rochester, MN
The purpose of this study is to explore thoughts and experiences of bladder cancer patients who underwent radical cystectomy at Mayo Clinic Florida through qualitative interviews.
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A Study To Learn How Research Sites Successfully Recruited To A Geriatric Oncology Trial That Relied On Electronic Patient-reported Outcomes (EPRO)
Rochester, MN
The purpose of this study is to analyze how research sites successfully recruit geriatric oncology patients using electronic-reported patient outcomes.
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Testing For Spread Of Stomach Cancer To Abdominal Cavity
Rochester, MN
The purpose of this study is to establish a clinical useful gene expression panel for detecting and predicting peritoneal relapse and survival to address the unmet clinical need for a simple and accurate staging of the peritoneum in gastric cancer.
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Combination Treatment Therapy Approaches For The Treatment Of High-Risk Multiple Myeloma, REACH Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to estimate the rate of sustained MRD negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma.
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Detection of Mutant Circulating Tumor (CT)Dna in Uveal Melanoma With Development of a Droplet Digital Pcr (Ddpcr) Assay
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of a ddPCR assay for the detection of mutations associated with uveal melanoma. The performance characteristics of the ddPCR assay for the detection of ctDNA mutation in uveal melanoma patients will be assessed by comparing the mutation results obtained for the ddPCR assay on blood to those obtained on paired paraffin embedded tumors.
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A Study Of RP2 With Nivolumab Compared To Ipilimumab With Nivolumab With Metastatic Uveal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall survival (OS) and to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on progression free survival (PFS).
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VG161 In The Treatment Of Patients With Hepatocellular Carcinoma Or Intrahepatic Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectie of Safety Run-In Cohort (Cohort 1) is to evaluate the safety and tolerability of multiple intratumoral injections (IT) of VG161 at the recommendated Phase 2 Dose (RP2D) in patients with HCC and ICC who have either disease progression or intolerable toxicity after the standard treatments.
The primary objective of HCC Cohort (Cohort 2) is to evaluate the efficacy of multiple IT injections of VG161 in patients with hepatocellular carcinoma (HCC).
The primary objective of ICC Cohort (Cohort 3) is to evaluate the efficacy of multiple IT injections of VG161 in patients with intrahepatic cholangiocarcinoma.
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Clinical Trial Of SP-2577 (Seclidemstat) In Patients With Relapsed Or Refractory Ewing Or Ewing-related Sarcomas
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of SP-2577 (seclidemstat) as a single agent and in combination with topotecan and cyclophosphamide (TC) in patients with relapsed or refractory Ewing sarcoma and select sarcomas.
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Clinical Features, Prognostic Factors, Local Control Modalities, Survival, and Outcomes of Ewing Sarcoma in Pediatric and Adult Patients
Rochester, MN
The purpose of this study is to compare clinical features and outcomes for children and adults with Ewing Sarcoma at the same institution and add to the limited clinical literature on adults with Ewing Sarcoma.
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A Study Of How Current Treatments Impact The Course Of Relapsed Myeloma And The Effect Of The Treatments On The Quality-of-life Measurements.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine the impact of standard of care therapies for TCR MM, in a real-world setting, on patient-reported symptoms, functioning, and QoL, measured prospectively using questionnaires. The secondary goal is to asses clinical endopoints associated with standard of care therapies for TCR MM, in a real-world setting during 12 months of observation.
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GMCI Plus Standard Of Care Immune Checkpoint Inhibitor For Stage III/IV NSCLC
Rochester, MN
The purpose of this study is to evaluate whether CAN-2409 + prodrug added to standard of care immune checkpoint inhibitor (ICI) therapy will be safe and improve the outcome for Non-small Cell Lung Cancer (NSCLC) patients that have stable disease or readiographic progression after at least 18 weeks of ICI therapy or that have refractory disease after at least 9 weeks of ICI therapy.
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Hairy Cell Leukemia Patient Data Registry
Rochester, MN
The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 600 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends ...
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Study Of REGN4018 Administered Alone Or In Combination With Cemiplimab In Adult Patients With Recurrent Ovarian Cancer Or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Rochester, MN
Primary Objectives In the Dose Escalation Phase:
- To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.
In the Dose Expansion Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Secondary Objectives In the Dose Escalation Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR ...
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Study Of EO-3021 In Adult Patients With Solid Tumors Likely To Express CLDN18.2
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the single-agent EO-3021 recommended phase 2 dose (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.
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A Study Of Vesicles, Prostate Cancer
Rochester, MN
The purpose of this study is to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) and circulating tumor DNA (ctDNA) across time and treatments.
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A Study To Investigate ALE.P02 As Monotherapy In Adult Patients With Selected CLDN1+ Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
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A Study To Evaluate Lymphoma Epidemiology
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to build a large and diverse observational cohort to support broad and cutting-edge research focused on non-Hodgkin lymphoma (NHL) prognosis and survivorship.
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A Study to Evaluate the Effectiveness and Safety of P276-00 for Mantle Cell Lymphoma that has Returned and/or is Resistant to Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine whether P276-00 is safe and effective for the treatment of Mantle Cell Lymphoma that has returned or is not responding to at least one previous line of treatment.
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Combination Of Serabelisib And Insulin Suppressing Diet In Subjects With Advanced Solid Tumors With PIK3CA Mutations
Rochester, MN
The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.
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Validation Of A Blood Assay For The Detection Of BRAF Mutation Status In Patients With Metastatic Melanoma
Rochester, MN
The purpose of this study is to validate an internally developed assay for the detection of BRAF V600E mutations in cfDNA from the peripheral blood of patients with melanoma.
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A Trial To Evaluate The Efficacy And Safety Of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN In Adult Patients With Relapsed Or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with bendamustine (BEN) to another treatment combination, rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL. MOR00208 is an investigational drug. RTX and BEN are both approved in many countries for the treatment of lymphomas. The combination of both is considered and recommended by some medical authorities in some other countries as an option to treat DLBCL.
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Study To Evaluate Safety And Tolerability Of XmAb13676 In Patients With CD20-expressing Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
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A Study Of BBI503 In Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Rochester, MN
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.
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Olanzapine For The Treatment Of Chronic Nausea And/or Vomiting In Advanced Cancer Patients
Mankato, MN; Rochester, MN
The purpose of this study is to conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
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The Impact Of A Geriatric Assessment In Elderly Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (≥ 65 years) with multiple myeloma (MM).
Multiple myeloma (MM) is a blood cancer that affects a type of white cell called plasma cell. It mainly affects older individuals and has an average age at diagnosis of 69 years.
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A Multi-center Trial To Evaluate Multiple Regimens In Metastatic Pancreatic Cancer
Rochester, MN
The primary objectives for this study are to compare each investigational arm versus standard of care (SOC) for superiority in overall survival in 1st and/or 2nd line metastatic pancreatic cancer patients, and to determine which, if any, patients benefit from each investigational arm.
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The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study To Test Bone Marrow And Blood In Children With Leukemia That Has Come Back After Treatment Or Is Difficult To Treat - A Leukemia & Lymphoma Society And Children's Oncology Group Study
Rochester, MN
The purpose of this study is to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials.
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KTX-100 MMSET Catalytic Inhibitor That Suppresses H3K36me2 In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and schedule and/or a recommended Phase 2 dose (RP2D) and schedule of KTX-1001 for patients with relapsed and refractory multiple myeloma.
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Radioiodine Planar And A SPECT/CT Imaging With Iodine-123 For Evaluation Of Follicular Thyroid Nodules Prior To Surgery
Rochester, MN
The objective of this study is to determine intensity of I-123 uptake in follicular thyroid lesions before surgery and correlate with final pathology findings.
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A Study To Evaluate LOXO-305 Vs. Approved BTK Inhibitor Approved Drugs To Treat Patients With Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
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Study Of CPI-0610 In Myelofibrosis (MF)
Jacksonville, FL
This study aims to determine the efficacy of CPI-0610 + ruxolitinib compared with placebo + ruxolitinibin patients with naive myelofibrosis (MF).
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A Study To Assess Adverse Events Of Intravenously (IV) Infused ABBV-383 In Adult Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383.
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KO-2806 Monotherapy And Combination Therapies In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
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Risk Stratified De-escalated De-intensified Treatment For High Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine, with an acceptable upper bound confidence interval, disease free survival in patients who receive hypofractionated radiation for high risk prostate cancer. Exploratory objectives include chronic/late toxicity, among others. Late toxicity rates in the current study should besimilar to what is previously reported.
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BCL2 Inhibitor Venetoclax With Daratumumab-Lenalidomide-Dexamethasone Or Venetoclax-Rd For Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to estimate the recommended phase II dose (RP2D) of venetoclax that can be combined with standard dose Dd combination (Arm A), Rd combination (Arm B) or daratumumab, lenalidomide and dexamethasone (Arm C) in patients with newly diagnosed t(11;14) multiple myeloma (MM).
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Study Of NMS-03597812 In Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Rochester, MN
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab Monotherapy In Participants With Select B-Cell Malignancies (MorningSun)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]).
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Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.
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A Study Of LOXO-783 In Patients With Breast Cancer/Other Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
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Long-term Follow Up Of Patients Previously Enrolled In MC1137 (BEAUTY)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to extend the follow up on the BEAUTY study (MC1137) cohort and collect additional blood samples to evaluate for minimal residual disease and tissue at the time of any breast cancer recurrence.
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A Study To Evaluate The Development Of Patient Derived Xenografts In Patients With Breast Cancer
Rochester, MN
Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer. We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy.
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A Study to Review the Safety of Familial Adenomatous Polyposis/Erlotinib Study
Scottsdale/Phoenix, AZ
The purpose of this study is to review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, who provide consent for the review of their medical records. There have been reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol. A review of literature found insufficient data to determine whether or not there is a longer term safety risk to the participant in MAY2016-07-01.
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A Study of STRO-001 in Patients with Advanced B-Cell Malignancies
Jacksonville, FL
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and preliminary effectiveness of STRO-001 given intravenously every 2 weeks to patients with advanced b-cell malignancies.
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A Study to See if the Depth of Tumor Invasion of Esophageal Carcinoma Predicts Lymph Node Involvement and Cancer Free Survival
Rochester, MN
The purpose of this study is to see if different depths of submucosal tumor invasion in esophageal cancer can predict lymph node involvement and survival.
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A Study to Explore Cancer Patient Experiences and Their Decisions About Sharing Genetic Cancer Screening Information with Family Members
Rochester, MN
The purpose of this study is to characterize the beliefs and attitudes of cancer patients who received a positive result from a genetic cancer screen as part of the Mayo Clinic Intercept study (IRB#18-000326, PI: Samadder). This data will be collected using semi-structured, one-on-one interviews.
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A Study To Evaluate Personalized Molecular Marker And Immunoprofiling To Transform Hepatocellular Carcinoma Treatment
Jacksonville, FL
The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets. Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents (or combinations) with particular tumor profiles.
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The In4M Study: Integrating 4 Measures To Assess Physical Function In Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the measurement characteristics of these different sources of physical function data in a cancer population undergoing cytotoxic chemotherapy.
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Virtual Reality Intervention To Improve Psychological Symptom Burden For Cancer Patients Undergoing Treatment
Jacksonville, FL
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to ...
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Combination Therapies With Adagrasib In Patients With Advanced NSCLC With KRAS G12C Mutation
Jacksonville, FL; Rochester, MN
The purpoes of this study is to evaluate the clinical effectiveness of combination therapies with adagrasib in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with TPS ≥ 1% and KRAS G12C mutation
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A Phase II Clinical Trial Comparing The Efficacy Of RO7198457 Versus Watchful Waiting In Patients With CtDNA-positive, Resected Stage II (High Risk) And Stage III Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
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A Comprehensive Evaluation Of Immunity In Lymphoma Patients
Rochester, MN
The purpose of this study is to address the current knowledge gaps by providing comprehensive and dynamic characterization of the different components of the immune system in patients diagnosed with lymphoma.
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A Study Of Unesbulin In Participants With Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory Leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.
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Study Of BMF-219, In Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), And Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy (Cohorts 1, 2, 3, and 4).
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Safety And Preliminary Efficacy Assessment Of AZD7789 In Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma
Rochester, MN
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
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A Study Of Oral LOXO-305 In Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Or Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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Phase 2 Study Of VGT-309 In Lung Cancer
Rochester, MN
The purpose of this study is to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
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A Study Of CLN-619 (Anti-MICA/MICB Antibody) In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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SX-682 Treatment In Subjects With Myelodysplastic Syndrome Who Had Disease Progression Or Are Intolerant To Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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NBTXR3 With Or Without Cetuximab LA-HNSCC
Jacksonville, FL
The purpose of this study is to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.
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PLX038 For The Treatment Of Metastatic Ovarian, Peritoneal, And Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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A Comprehensive Translational Research Platform For Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or ...
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Interviews About Social Determinants Of Health In Southeast Asian Americans To Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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A Study To Analyze The Association Between Financial And Health Insurance Literacy And Financial Distress In Patients Being Treated For Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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CJNJ-67652000 And Prednisone For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer And SPOP Gene Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response ...
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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Ulixertinib In People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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MC240508: Genomic Surveillance Of Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to ...
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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A Study Of MK-1026 In Patients With Selected Hematologic Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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Profiling Of Lung Cancer For Identification Of Treatment Targets And Strategies
Jacksonville, FL
The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.
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Study Assessing Activity Of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies In Adult Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma.
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Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery
Rochester, MN
This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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A Colon Bank for Early Detection of Colon Cancer
Rochester, MN
The purpose of this study is to establish a biobank of samples (blood and stool) to support the development of non-invasive tests for early detection of colon cancer and its precursors.
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Phase I/II Study Of The Combination Of Blinatumomab And Asciminib In Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
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A Study To Assess The Adverse Events And Change In Disease Activity In Adult Participants With Relapsed Or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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A Study To Assess Financial Burden And Its Impact On Quality Of Life In Patients With Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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A Safety Study Of SEA-TGT (SGN-TGT) In Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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Biomarkers To Predict For And Monitor Response To PD-1/PD-L1 Inhibitors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.
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A Trial Of TTI-621 For Patients With Hematologic Malignancies And Selected Solid Tumors
Jacksonville, FL; Rochester, MN
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy In Patients With Advanced Cutaneous Melanoma Or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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HeadStart4: Newly Diagnosed Children (<10 Y/o) With Medulloblastoma And Other CNS Embryonal Tumors
Rochester, MN
The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a ...
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A Phase 1 Study Of The Safety And Tolerability Of MT-125 In GBM Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.
Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to ...
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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A Study Of Ziftomenib, An Oral Menin Inhibitor, In Combination With Imatinib In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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Onvansertib For The Treatment Of Recurrent Or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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A Trial To Assess Effectiveness And Safety Of Octreotide Subcutaneous Depot In Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML).
The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the ...
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A Study To Evaluate Feasibility Of In Vivo Sensitivity Screen Using Direct Tumor Microinjection And FDG-PET In Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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Testing An Active Form Of Tamoxifen (4-hydroxytamoxifen) Delivered Through The Breast Skin To Control Ductal Carcinoma In Situ (DCIS) Of The Breast
No Locations
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
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Myeloproliferative Neoplasm Pain Management and Patient Habit Survey
Scottsdale/Phoenix, AZ
This study aims to evaluate the complexities of Myeloproliferative neoplasms (MPN) pain and review current treatment strategies through an online survey of MPN patients. The results of this preliminary investigation will provide the groundwork for future prospective studies addressing the MPN symptom burden.
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Cardio-Oncology Clinic Registry
Rochester, MN
The purpose of this study is to establish a retrospective and prospective clinical registry of patients seen in the cardio-oncology clinic to characterize trends in the composition and outcomes of the population seen in the clinic, as well as initial clinical analyses on cardiovascular toxicities.
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FT576 in Subjects With Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the recommended phase II dose for FT576 when administered as monotherapy and in combination with daratumumab, and to evaluate the safety and tolerability of FT576 when administered as monotherapy and in combination with daratumumab
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Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer
Jacksonville, FL
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may ...
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A Study To Investigate The Safety And Efficacy Of SAR446523 Injected Subcutaneously In Adult Participants With Relapsed/Refractory Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.
Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), ...
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RP2/RP3 In Combination With Atezolizumab And Bevacizumab For The Treatment Of Patients With CRC
Scottsdale/Phoenix, AZ; Rochester, MN
The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
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Extracorporeal Photopheresis And Mogamulizumab For The Treatment Of Erythrodermic Cutaneous T Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma.
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Extracorporeal Photopheresis And Mogamulizumab For The Treatment Of Erythrodermic Cutaneous T Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma.
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Study Of Ociperlimab In Combination With Tislelizumab In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objectives of this study are to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion.
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Cholangiocarcinoma Liquid Biopsy Monitoring For Treatment Response And Prognostic Outcomes
Rochester, MN
The purpose of this study is to investigate the utility of using a PUMA (Proteins, mUtations, Methylated DNA, and Aneuploidy markers) platform to prognosticate and assess treatment response in patients with cholangiocarcinoma.
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Shared Decision-Making Encounter Tool For Decisions Of Adjuvant Treatment In Patients With Resected Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected Non-Small Cell Lung Cancer.
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ICCaRE Consortium Pilot Project 1: Feasibility Of A Point Of Prostate Cancer Diagnosis Intervention For Newly Diagnosed Black Men
Jacksonville, FL
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
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Perceived Financial Hardship In Patients With Multiple Myeloma And Their Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to examine the agrrement in perception of finacial hardship (FH) and the perceived stress in patients with multiple myeloma (MM) and their caregivers (CG). Additionally, we will describe protective buffering/emotional disclosure in patients with MM and their CGs and examine their association with FH, and perceived stress.
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A Study To Determine Baseline Levels For Prostate Cancer-Derived Particles Containing Cellular Matter (Extracellular Vesicles) After Local Treatment
Rochester, MN
The purposes of this study are to determine the levels of prostate cancer-derived extracellular vesicles pre- and post-local therapy (radical prostatectomy or radiation therapy), to correlate analysis for PSA levels and prostate cancer-derived extracellular vesicles, and to determine baseline levels of prostate cancer-derived extracellular vesicles in patients undergoing different lines of primary local treatment.
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A Phase 1B/2 Study Of RP1 In Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients.
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A Study To Assess The Safety And Tolerability Of CFT8634 In Locally Advanced Or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma And SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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A Phase I/II Study To Evaluate AZD5851 In GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
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Rem-422, An MYB MRNA Degrader, In Patients With Relapsed/Refractory AML Or Higher-Risk MDS
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of REM-422 in patients with relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes.
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A Phase 1/2a Study Of IMM-1-104 In Participants With Previously Treated, RAS-Mutant, Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy in participants with RAS-mutated advanced or metastatic solid tumors.
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A Study Evaluating The Efficacy And Safety Of Cevostamab In Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma (CAMMA 2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).
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Evaluating Intraoperative Indocyanine Green Dye Fluorescence Angiography For Sarcoma Resectiong
Rochester, MN
The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.
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Phase 2 Study To Evaluate Safety And Efficacy Of Cretostimogene Grenadenorepvec In NMIBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer
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A Phase 1 Study Of XL309 (ISM3091) Alone And In Combination In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.
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Study To Evaluate The Efficacy And Safety Of BGB-11417 In Participants With Waldenström's Macroglobulinemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
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Pilot Study Of Antineoplastic
Rochester, MN
The purpose of this study is to use therapeutic drug monitoring (trough plasma concentrations of dabrafenib, hydroxy dabrafenib, and/or trametinib) along with CYP3A4/CYP3A5 and CYP2C8 genotyping and BRAF mutation quantification will correlate with effectiveness (based on imaging studies) and/or toxicity (pyrexia, liver dysfunction, rash) in known melanoma patients.
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Phase 1/2 Study Of MRTX1719 In Solid Tumors With MTAP Deletion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
Rochester, MN
The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.
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ADG126 In Combination With Pembrolizumab In Patients With Advanced/Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN
This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.
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A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia
Rochester, MN
AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients ...
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Solid Tumor Monoclonal B-cell Lymphocytosis Screening
Rochester, MN
The purpose of this study is to determine whether monoclonal B-cell lymphocytosis (MBL) has an impact on clinical outcomes among patients with a diagnosis of a solid tumor.
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Phase 3 Study Of Daraxonrasib (RMC-6236) In Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
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Pancreatic Cancer Detection Consortium
Rochester, MN
The purpose of this study is to develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at high-risk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts. Additionally to follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes and to make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.
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Ketoconazole In Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Rochester, MN
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
We would like to see if use of topical ketoconazole will improve rashes in patients with EGFR inhibitor-induced rash.
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Study Of Biomarker-Based Treatment Of Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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Dose-Escalation Study Of Cevostamab (BFCR4350A) In Participants With Relapsed Or Refractory Multiple Myeloma (R/R MM)
Scottsdale/Phoenix, AZ
This is a phase I, multicenter, open-label, dose-escalation study of cevostamab (BFCR4350A) administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).
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CC-220-MM-001: A Phase 1b/2a Multicenter, Open-Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Assess The Safety, Tolerability, Pharmacokinetics And Efficacy Of CC-220 As Monotherapy And In Combination With Other Treatments In Subjects With Multiple Myeloma
Scottsdale/Phoenix, AZ
This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT) and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
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A Study Of APG-2575 Alone Or In Combination With Other Therapeutic Agents To Treat Relapsed And/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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A Study Of WVT078 In Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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A Study Of Effect Of Different Biochemical Markers Including Leptin And Spexin In Children Before And After Having Hypothalamus Surgery
Rochester, MN
The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.
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A Study To Evaluate The Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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Iodine I-131 With Or Without Selumetinib In Treating Patients With Recurrent Or Metastatic Thyroid Cancer
Rochester, MN
This randomized phase II trial studies how well iodine I-131works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Because of this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose ...
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Testing The Effects Of Novel Therapeutics For Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a ...
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Study Using Chromogranin A As Surveillance Biomarker In Patients With CARcinoids
Rochester, MN
The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).
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A Study To Evaluate The Safety And Effectiveness Of AB928-Based Treatment Combinations To Treat Patients With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the clinical activity, safety and tolerability of etruma-based treatment combinations.
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A Study To Evaluate The Adverse Events, And Efficacy Of Intravenous (IV) Of Telisotuzumab Adizutecan In Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and ...
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Study Of The Theranostic Pair RYZ811 (Diagnostic) And RYZ801 (Therapeutic) To Identify And Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
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A Study Of TAS-120 In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the antitumor activity of TAS-120 as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor (FGFR) amplifications.
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The Young Women's Breast Cancer Study
Rochester, MN
The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed. Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years (for a total follow-up of at least 10 years following diagnosis). The study investigates short and long-term disease and treatment ...
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A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
Rochester, MN
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
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Black Prostate Cancer Survivors
Jacksonville, FL
The purpose of this study is to investigate the experiences and challenges faced by Black men in their journey of surviving prostate cancer. By exploring various aspects of survivorship, including physical, emotional, and social dimensions, this research aims to provide valuable insights into the unique needs of this population and inform the development of targeted support interventions.
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A Registry For People With Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine 3- and 5-year disease-free survival (DFS) among patients undergoing pulmonary segmentectomy for lung cancer. Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
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CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study In Lung (DELFI-L201)
Rochester, MN
The purpose of this study is to determine the sensitivity and specificity of a blood test (DLCST) for the detection of lung cancer in a screening setting using the reference of Chest CT screening and a histologic diagnosis of lung cancer.
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A Study Of The Bacteria Found In Cancerous And Non-cancerous Breast Tissue
Rochester, MN
The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.
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CAncer Survivor CArdiomyopathy DEtection (CASCADE) Pilot Study
Rochester, MN
The purpose of this study is to improve the cardiovascular care of adult cancer survivors by contributing much-needed evidence regarding optimal surveillance and treatment recommendations. This application’s objective is to obtain the data necessary to plan an adequately powered randomized clinical trial (RCT) across a nation-wide network that will define prospectively the clinical and economic efficacy of a screening program that uses AI-ECG and/or NT-pro-BNP in an at-risk adult cancer survivor population.
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Group Curriculum For Improving Survivorship Outcomes In Adolescent And Young Adult Cancer Survivors
Scottsdale/Phoenix, AZ
The purpose of this study is to develop the curriculum and assess its feasibility and impact on equipping young adults to better manage these aspects of survivorship: follow up medical care, work/school life, relationships and coping with the emotional impact of cancer survivorship.
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SRG-514 Administered Intraoperatively To Patients Undergoing Breast-conserving Cancer Surgery
Rochester, MN
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.
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CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study In Lung (DELFI-L201)
Rochester, MN
The purpose of this study is to determine the sensitivity and specificity of a blood test (DLCST) for the detection of lung cancer in a screening setting using the reference of Chest CT screening and a histologic diagnosis of lung cancer.
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A Study Of The Bacteria Found In Cancerous And Non-cancerous Breast Tissue
Rochester, MN
The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.
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Group Curriculum For Improving Survivorship Outcomes In Adolescent And Young Adult Cancer Survivors
Scottsdale/Phoenix, AZ
The purpose of this study is to develop the curriculum and assess its feasibility and impact on equipping young adults to better manage these aspects of survivorship: follow up medical care, work/school life, relationships and coping with the emotional impact of cancer survivorship.
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A Study To Evaluate Gemcitabine In Patients Undergoing Radical Nephroureterectomy For Upper Tract Urothelial Carcinoma
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).
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Prostate Cancer Cell Lines Using Biopsies Of Early Stage Prostate Cancer Patients And Research On Cancer Mechanisms Through Its Genes And Proteins
Rochester, MN
The purpose of this study aims to establish a total of 30 new primary prostate cancer cell lines using a portion of biopsy tissue from early-stage prostate cancer patients and to collect protein characterization data showing high expression for each cell line. The primary objective is to discover specific genes and proteins that show excessive expression differences in each group of prostate cancer cell lines. The specific genes and proteins obtained here will be used to find customized anticancer candidates for prostate cancer patients in the future. As a final objective, we aim to build a new classification of existing ...
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Etiology, Prevention And Therapy Navigation Of Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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A Study Of CTX-009 In Combination With Paclitaxel In Adult Patients With Unresectable Advanced, Metastatic Or Recurrent Biliary Tract Cancers (COMPANION-002)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with biliary tract cancers (BTC) who have received one systemic therapy for advanced disease, as measured by Overall Response Rate (ORR) assessed by an Independent Central Radiology (ICR) review.
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A Study To Compare Treatment With The Drug Selumetinib Alone Versus Selumetinib And Vinblastine In Patients With Recurrent Or Progressive Low-Grade Glioma
Rochester, MN
The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.
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A Trial Of TTI-621 In Combination With Doxorubicin In Patients With Leiomyosarcoma
Jacksonville, FL
The purpose of this study to evaluate TTI-621 combined with Doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma.
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A Study To Evaluate Effectiveness And Safety Of MBG453 In Combination With Azacitidine In Subjects With Intermediate, High Or Very High Risk Myelodysplastic Syndrome (MDS), Or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of MBG453, or placebo added to azacitidine, in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.
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Bemarituzumab Or Placebo Plus Chemotherapy In Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main objective of this study is to compare effectiveness of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).
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(Peak) A Phase 3 Randomized Trial Of CGT9486+Sunitinib Vs. Sunitinib In Subjects With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare CGT9486 in combination with sunitinib to treat gastrointestinal stromal tumors.
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Vinorelbine Tartrate and Cyclophosphamide in Combination with Bevacizumab or Temsirolimus in Treating Patients with Recurrent or Refractory Rhabdomyosarcoma
No Locations
This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide work in combination with bevacizumab or temsirolimus in treating patients with recurrent or refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop ...
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Eau Claire, WI
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin ...
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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A Study of Using Bortezomib and Combination Chemotherapy in Treating Children with Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Rochester, MN
This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
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Thoracotomy Versus Thoracoscopic Management Of Pulmonary Metastases In Patients With Osteosarcoma
Rochester, MN
The purpose of this study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
Furthermore, to determine if open surgical resection is superior to thoracoscopy for event free survival (EFS), for overall survival (OS), and if thoracoscopy is superior to open surgical resection for postoperative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.
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Tele-Medicine In An Advanced Prostate Cancer Clinic
Rochester, MN
The purpose of this study is to describe the use of tele-medicine during the COVID-19 pandemic in our advance prostate cancer practice and evaluate patient satisfaction.
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A Study To Evaluate Docetaxel With Or Without Bintrafusp Alfa To Treat Patients With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study Of DCC-2618 Vs. Sunitinib In Advanced GIST Patients After Treatment With Imatinib
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
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A Study To Evaluate Family Member Exposure To Antineoplastic Drugs In The Home Setting
Eau Claire, WI
The purpose of this study is to quantify active antineoplastic drug metabolites in the urine samples, oral fluids, and skin of patients receiving intravenous chemotherapy on days 1 through 7 post infusion, to quantify active antineoplastic drug metabolites in the urine samples of family member/caregiver of patient receiving chemotherapy on days 1 through 7 post infusion, and to identify the instructions received by patient/family members to avoid exposure to contaminated bodily fluids from patients’ receiving intravenous antineoplastic drugs and whether the instructions were followed.
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A Study To Evaluate The Effectiveness And Safety Of Pemigatinib Versus Chemotherapy In Unresectable Or Metastatic Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
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Vaccine Therapy In Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, Or Primary Peritoneal Cavity Cancer Following Surgery And Chemotherapy
Rochester, MN
This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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A Clinical And Molecular Risk-Directed Therapy For Newly Diagnosed Medulloblastoma
No Locations
The purpose of this study is to tailor treatment for medulloblastoma based on molecular distinctions between tumors in order to improve cure rates for molecularly aggressive medulloblastoma, while reducing treatment-related morbidities in survivors of less aggressive medulloblastoma. It is possible that subjects in this study will benefit from a reduction in treatment complications, more effective therapy, and higher rates of survival.
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Combination Therapy Of Acalabrutinib, Venetoclax And Durvalumab To Treat Richter Transformation
Rochester, MN
The purpose of this study is to determine if the drug combination of acalabrutinib, durvalumab, and venetoclax will work to treat Richter’s transformation, and what doses of these drugs are safe for people to take. We also want to learn about the side effects of this combination. All study subjects will receive acalabrutinib, durvalumab, and venetoclax. Acalabrutinib is FDA approved for treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Durvalumab is FDA approved for treatment in lung cancers including non-small cell lung cancer and small cell lung cancer. Venetoclax is FDA approved for the treatment of CLL and SLL. ...
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A Trial Of Pirtobrutinib (LOXO-305) Plus Venetoclax And Rituximab (PVR) Versus Venetoclax And Rituximab (VR) In Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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Study Of Onvansertib In Combination With FOLFIRI And Bevacizumab Versus FOLFIRI And Bevacizumab For Second Line Treatment Of Metastatic Colorectal Cancer In Participants With A Kirsten Rat Sarcoma Virus Gene (KRAS) Or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Radiotherapy To Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs?
This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to test an experimental combination of two drugs, ABT-888 and Cyclophosphamide (CP), which we hope may eventually lead to promising new therapies for cancer.
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Comparison of Mitoxantrone-Based Salvage Therapies (MEC vs CLAG-M) in Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ
The purpose of this study is to determine potential differences between the 2 therapeutic regimens.
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Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer
Jacksonville, FL
This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.
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Radiation Treatment Planning Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to integrate a novel head and neck segmentation algorithm into the current clinical standard operating procedure for radiation treatment planning within the Mayo Clinic Department of Radiation Oncology Practice.
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3D Surface Scanning
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the potential for using a 3D scan of a patient’s treatment surface as a surrogate for a conventional CT simulation in electron radiation therapy.
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A Study To Evaluate Ramucirumab Plus Trifluridine/Tipiracil To Treat Patients With Previously-treated Advanced Gastric Or Gastro-esophageal Junction Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/Gastroesophageal Junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with TAS-102 vs. paclitaxel and ramucirumab.
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Dabrafenib Combined With Trametinib After Radiation Therapy In Treating Patients With Newly-Diagnosed High-Grade Glioma
Rochester, MN
The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.
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A Study To Evaluate Trifluridine/Tipiracil In Combination With Irinotecan To Treat Biliary Tract Cancers
Rochester, MN
The purpose of this study is assess the effectiveness of trifluridine/tipiracil plus irinotecan in treating advanced, refractory biliary tract cancers (BTCs).
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A Study To Evaluate Ribociclib Plus Letrozole To Treat Cancer Of The Ovary, Fallopian Tube Or Peritoneum
Rochester, MN
The purpose of this study is to evaluate the response to treatment with Ribociclib and Letrozole in patients with low-grade serous cancer of the ovary, fallopian tube or peritoneum.
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Accelerated Vs Standard BEP Chemotherapy For Patients With Intermediate And Poor-risk Metastatic Germ Cell Tumours
Rochester, MN
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
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Metformin Hydrochloride And Combination Chemotherapy In Treating Patients With Stage III-IV Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Rochester, MN
This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors ...
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A Study To Assess Multiparametric MRI In Evaluating Cancer Stage And Helping Treatment Planning In Patients With Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
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Wild-Type Reovirus In Combination With Sargramostim In Treating Younger Patients With High-Grade Relapsed Or Refractory Brain Tumors
Rochester, MN
This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.
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Phase 3 Frontline Therapy Trial In Patients With Advanced Classical Hodgkin Lymphoma
Rochester, MN
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
Rochester, MN
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib ...
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A Study Of TAR-200 In Combination With Cetrelimab And Cetrelimab Alone In Participants With Muscle-Invasive Urothelial Carcinoma Of The Bladder
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with cetrelimab and cetrelimab alone.
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A Phase 1b/2 Study Of Onvansertib (PCM-075) In
Combination With FOLFIRI And Bevacizumab For
Second-Line Treatment Of Metastatic Colorectal Cancer
in Patients With A KRAS Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of Onvansertib, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
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Evaluating Patient Reported Outcomes In Radiation Therapy, The PRO-RT Study
Rochester, MN
The purpose of this study is to address the gaps in data completeness regarding treatment toxicities, patient reported outcomes, and biometric information. Hugo device enabled patient specific data aggregation, will increase the completeness and accuracy of the Outcomes Registry and improve patient engagement with the care teams, post radiation, by acquiring linked outside EHR information facilitating improved collection of patient reported outcome surveys, and biometric data via a wearable device.
With a rise in health care costs, there is an urgent need to evaluate patient outcomes and the value of care levering real patient, big data from the ...
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Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
Rochester, MN
The purpose of this study is to look at the safety and immune response to a vaccine used in patients previously treated for HER2 (human epidermal growth factor receptor 2) positive breast cancer.
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Collection Of Specimens And Clinical Data For Patients With Recurrent Or Metastatic Breast Cancer Or Male Breast Cancer
Rochester, MN
The purpose of this study is to collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer. The biospecimens will be used for analysis of genetic alterations in germline and tumor DNA and for tracking of response to therapy using blood-based liquid biopsy approaches.
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A Blood Collection Protocol To Study The Immune Responses Of Cancer Patients With Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic ...
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SUPRAME-ACTengine® IMA203 Vs. Investigator's Choice Of Treatment In Previously Treated, Unresectable Or Metastatic Cutaneous Melanoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.
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A Study To Evaluate Accelerated Resolution Therapy In Cancer And Palliative Care
Jacksonville, FL
The following research questions will guide this study: 1) Is ART feasible and acceptable for use with distressed patients and/or family caregivers in oncology and palliative care clinical settings? 2) What is the mean dose of ART provided to distressed patients and/or family caregivers? 3) What are the patient and family stressors that result in a recommendation for ART? 4) Does ART reduce symptoms of psychological trauma, anxiety and depression, when used with distressed patients and family caregivers in oncology and palliative care clinical settings? 5) Does ART improve resilience when used with distressed ...
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PF-07284892 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
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Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
Rochester, MN
The purpose of this study is to evaluate nurse-based care coordination compared to usual care on 30-day risk-adjusted readmission rates among high risk patients.
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Radioembolization With Tremelimumab And Durvalumab For Locally Advanced Unresectable Or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to assess the safety and preliminary efficacy of segmental ablative radioembolization in combination with Tremelimumab plus Durvalumab (MEDI4736) in patients with cholangiocarcinoma who are not candidates for curative therapy. transplantation will be enrolled in two cohorts.
The primary objective of the study is to characterize the safety of the combination of Y90 TARE, durvalumab and tremelimumab. As a secondary objective, the study will assess the overall efficacy of Y90 in combination with therapty as guaged by patient response rate.
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A Study To Reduce Disparities In High-Risk Black Men (BM) With Advanced Prostate Cancer Using Patient-Centered Home Care
Jacksonville, FL
The purpose of this study is to evaluate a highly innovative project evaluating the feasibility of patient-centered home care (PCHC) as a new model of cancer care to reduce disparities and improve health related qualtiy of life (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP).
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A Study To See If Memantine Protects The Brain During Radiation Therapy Treatment For A Brain Tumor
Rochester, MN
This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.
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Testing The Addition Of Ixazomib To Lenalidomide In Patients With Evidence Of Residual Multiple Myeloma, OPTIMUM Trial
La Crosse, WI; Rochester, MN
This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Jacksonville, FL; Rochester, MN
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving ...
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PH 1 Study To Evaluate Safety And Tolerability Of XmAb14045 In Patients With CD123-expressing Hematologic Malignancies
Jacksonville, FL
Primary Objectives
1. To determine the safety and tolerability profile of weekly IV dosing of XmAb14045
2. To identify the first dose MTD/RD
3. At first dose MTD/RD, to then identify the second (and subsequent) infusion MTD/RD
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Tumor Heterogeneity Of The Tumor Microenvironment In Malignant Pleural Mesothelioma (MPM)
Rochester, MN
The purpose of this study is to:
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Evaluate MPM tumor heterogeneity by determining the agreement of histology, molecular abnormalities, neo-antigen expression and immunological biomarkers between three tumor samples from MPM patients.
- Compare the information from tumor samples to pleural fluid, peripheral blood and density based radiomics analysis.
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A Study To Evaluate Treatment Of Established Chemotherapy-induced Neuropathy With Fingolimod
Mankato, MN; Rochester, MN
The purpose of this study is to determine if the use of Fingolimod can reduce neuropathy caused by chemotherapy.
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Testicular Tissue Cryopreservation In Children
Rochester, MN
This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.
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Study Of Tirabrutinib (ONO-4059) In Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purose of this study is to evaluate the effiectiveness, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory Primary Central Nervous System Lymphoma PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolimide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B). Mayo Clinic is only participatin gin Part B, and only in the MTR regimen.
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Compare The Efficacy And Safety Of Golcadomide Plus R-CHOP Vs Placebo Plus RCHOP In Participants With Previously Untreated High-risk Large B-cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the investigator.
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A Study Of Elotuzumab, Daratumumab, Iberdomide, And Dexamethasone For Relapsed Multiple Myeloma
Rochester, MN
The purpose of this study is to assess the maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) in patients with relapsed MM. To determine the overall response rate with iberdomide, daratumumab, elotuzumab and dexamethasone (IberDEd) when used as therapy in patients with relapsed multiple myeloma.
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Quizartinib Or Placebo Plus Chemotherapy In Newly Diagnosed Patients With FLT3-ITD Negative AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
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Actinium Therapy For Late-stage Aggressive Sarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn about the safety of drug \[Ac225\]RTX-2358 and the diagnostic imaging agent \[Cu64\]LNTH-1363S. Additionally Ratio Therapeutics will learn if \[Ac225\]RTX-2358 drug is effective in treating advanced sarcoma.
The main questions the study aims to answer in Phase/Part 1 of the trial are:
* Is \[Ac225\]RTX-2358 tolerable or does it cause toxicities (medical problems) in patients.
* What is the most tolerable dose of \[Ac225\]RTX-2358
* Does the treatment show effectiveness on advanced sarcoma
Participants will:
* Take drug \[Ac225\]RTX-2358 once every 8 weeks (4 cycle target; 6 cycle maximum) over a period of 12 months
* Visit the clinic ...
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A Study Of CTX-009 In Combination With Paclitaxel In Adult Patients With Unresectable Advanced, Metastatic Or Recurrent Biliary Tract Cancers (COMPANION-002)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with biliary tract cancers (BTC) who have received one systemic therapy for advanced disease, as measured by Overall Response Rate (ORR) assessed by an Independent Central Radiology (ICR) review.
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A Study To Compare Treatment With The Drug Selumetinib Alone Versus Selumetinib And Vinblastine In Patients With Recurrent Or Progressive Low-Grade Glioma
Rochester, MN
The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.
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A Trial Of TTI-621 In Combination With Doxorubicin In Patients With Leiomyosarcoma
Jacksonville, FL
The purpose of this study to evaluate TTI-621 combined with Doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma.
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A Study To Evaluate Gemcitabine In Patients Undergoing Radical Nephroureterectomy For Upper Tract Urothelial Carcinoma
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).
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Prostate Cancer Cell Lines Using Biopsies Of Early Stage Prostate Cancer Patients And Research On Cancer Mechanisms Through Its Genes And Proteins
Rochester, MN
The purpose of this study aims to establish a total of 30 new primary prostate cancer cell lines using a portion of biopsy tissue from early-stage prostate cancer patients and to collect protein characterization data showing high expression for each cell line. The primary objective is to discover specific genes and proteins that show excessive expression differences in each group of prostate cancer cell lines. The specific genes and proteins obtained here will be used to find customized anticancer candidates for prostate cancer patients in the future. As a final objective, we aim to build a new classification of existing ...
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Etiology, Prevention And Therapy Navigation Of Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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A Study To Evaluate Effectiveness And Safety Of MBG453 In Combination With Azacitidine In Subjects With Intermediate, High Or Very High Risk Myelodysplastic Syndrome (MDS), Or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of MBG453, or placebo added to azacitidine, in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.
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Bemarituzumab Or Placebo Plus Chemotherapy In Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main objective of this study is to compare effectiveness of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).
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(Peak) A Phase 3 Randomized Trial Of CGT9486+Sunitinib Vs. Sunitinib In Subjects With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare CGT9486 in combination with sunitinib to treat gastrointestinal stromal tumors.
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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A Study of Using Bortezomib and Combination Chemotherapy in Treating Children with Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Rochester, MN
This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
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Vinorelbine Tartrate and Cyclophosphamide in Combination with Bevacizumab or Temsirolimus in Treating Patients with Recurrent or Refractory Rhabdomyosarcoma
No Locations
This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide work in combination with bevacizumab or temsirolimus in treating patients with recurrent or refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop ...
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Eau Claire, WI
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin ...
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Vaccine Therapy In Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, Or Primary Peritoneal Cavity Cancer Following Surgery And Chemotherapy
Rochester, MN
This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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A Study Of DCC-2618 Vs. Sunitinib In Advanced GIST Patients After Treatment With Imatinib
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
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A Study To Evaluate Family Member Exposure To Antineoplastic Drugs In The Home Setting
Eau Claire, WI
The purpose of this study is to quantify active antineoplastic drug metabolites in the urine samples, oral fluids, and skin of patients receiving intravenous chemotherapy on days 1 through 7 post infusion, to quantify active antineoplastic drug metabolites in the urine samples of family member/caregiver of patient receiving chemotherapy on days 1 through 7 post infusion, and to identify the instructions received by patient/family members to avoid exposure to contaminated bodily fluids from patients’ receiving intravenous antineoplastic drugs and whether the instructions were followed.
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Thoracotomy Versus Thoracoscopic Management Of Pulmonary Metastases In Patients With Osteosarcoma
Rochester, MN
The purpose of this study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
Furthermore, to determine if open surgical resection is superior to thoracoscopy for event free survival (EFS), for overall survival (OS), and if thoracoscopy is superior to open surgical resection for postoperative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.
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Tele-Medicine In An Advanced Prostate Cancer Clinic
Rochester, MN
The purpose of this study is to describe the use of tele-medicine during the COVID-19 pandemic in our advance prostate cancer practice and evaluate patient satisfaction.
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A Study To Evaluate Docetaxel With Or Without Bintrafusp Alfa To Treat Patients With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study To Evaluate The Effectiveness And Safety Of Pemigatinib Versus Chemotherapy In Unresectable Or Metastatic Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
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A Clinical And Molecular Risk-Directed Therapy For Newly Diagnosed Medulloblastoma
No Locations
The purpose of this study is to tailor treatment for medulloblastoma based on molecular distinctions between tumors in order to improve cure rates for molecularly aggressive medulloblastoma, while reducing treatment-related morbidities in survivors of less aggressive medulloblastoma. It is possible that subjects in this study will benefit from a reduction in treatment complications, more effective therapy, and higher rates of survival.
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Combination Therapy Of Acalabrutinib, Venetoclax And Durvalumab To Treat Richter Transformation
Rochester, MN
The purpose of this study is to determine if the drug combination of acalabrutinib, durvalumab, and venetoclax will work to treat Richter’s transformation, and what doses of these drugs are safe for people to take. We also want to learn about the side effects of this combination. All study subjects will receive acalabrutinib, durvalumab, and venetoclax. Acalabrutinib is FDA approved for treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Durvalumab is FDA approved for treatment in lung cancers including non-small cell lung cancer and small cell lung cancer. Venetoclax is FDA approved for the treatment of CLL and SLL. ...
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A Trial Of Pirtobrutinib (LOXO-305) Plus Venetoclax And Rituximab (PVR) Versus Venetoclax And Rituximab (VR) In Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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Study Of Onvansertib In Combination With FOLFIRI And Bevacizumab Versus FOLFIRI And Bevacizumab For Second Line Treatment Of Metastatic Colorectal Cancer In Participants With A Kirsten Rat Sarcoma Virus Gene (KRAS) Or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Radiotherapy To Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs?
This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
Rochester, MN
The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.
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Testing The Use Of Ado-Trastuzumab Emtansine Compared To The Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) For Recurrent, Metastatic, Or Unresectable HER2-Positive Salivary Gland Cancer
Rochester, MN
The purpose of this study is to test whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them.
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Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy In Previously Treated Advanced Or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations Or Other Genomic Alterations (MK-2870-004)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare MK-2870 to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations.
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A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, And Elotuzumab, Pomalidomide, And Dexamethasone Or Pomalidomide, Bortezomib, And Dexamethasone In Participants With Relapsed Or Refractory Myeloma Who Have Received An Anti-CD38 Antibody And Lenalidomide
Rochester, MN
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) For The Local Staging Of Rectal Cancer
Rochester, MN
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
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Study To Evaluate The Safety And Efficacy Of Magrolimab In Combination With Azacitidine Versus Physician's Choice Of Venetoclax In Combination With Azacitidine Or Intensive Chemotherapy In Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare the effectiveness of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).
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Colorectal Cancer Screening/Microbiome Collection
Jacksonville, FL
The purpose of this study is to evaluate the integration of cancer genetic testing into a cancer clinical practice aimed towards patients of various ethnic populations in Arizona and Florida – including, but not limited to, Hispanic/Latino, Native American/Alaskan, African American, and Asian by self-report.
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A Long Term Follow Up Of Mammography Screening
Rochester, MN
The purpose of this study is to execute a long-term retrospective observational cohort study of women who underwent screening mammography (defined as digital mammography or tomosynthesis).
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Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
Jacksonville, FL
The purpose of this study is to evaluate GDA-201, an allogeneic cryopreserved NK cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).
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Study Of RP-6306 With Gemcitabine In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
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A Study To Assess The Effectiveness And Safety Of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin In Patients Not Previously Treated For Metastatic Pancreatic Cancer, Compared To Nab-paclitaxel+Gemcitabine Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to look at the effectiveness and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
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Anti-VEGF Gene Therapy Trial For Vestibular Schwannoma
Rochester, MN
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
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A Study To Evaluate Trabectedin With Olaparib In Advanced Unresectable Or Metastatic Sarcoma
Rochester, MN
The purpose of this study is to evaluate how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body.
Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
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A Study To Evaluate DS-8201a Combined With Olaparib In HER2-Expressing Cancers With Expansion In Endometrial Cancer Patients
Testing The Combination Of DS-8201a And Olaparib In HER2-Expressing Cancers With Expansion In Patients With Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of the combination of DS-8201a in combination with olaparib, and to determine the recommended phase 2 dose (RP2D) 1.1.2 To evaluate the safety and tolerability of this combination in a dose expansion cohort in patients with uterine serous carcinoma.
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Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is determine objective response rate (ORR) by RECIST 1.1 by blinded independent central review (BICR) of envafolimab (cohort A), and of envafolimab combined with ipilimumab at 1 mg/kg (cohort B), in separate cohorts of patients with locally advanced, unresectable or metastatic UPS/MFS that has progressed following one or two lines of chemotherapy, without a formal statistical comparison between the two cohorts.
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Incidence of Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to determine the percentage of patients receiving cancer-directed therapy at the Gonda 10 chemotherapy unit who have had or are currently experiencing symptoms of nasal vestibulitis.
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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients with Myelofibrosis
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.
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Grief Among Older Adult Family Caregivers
Jacksonville, FL
The purpose of this study is to evaluate the trajectory of loss and grief over 12 months, the risk factors associated with high levels of pre-loss grief, and the preliminary effectiveness of ART for treatment of high levels of pre-loss grief among family caregivers (FCG) of persons nearing the end of life.
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Cyclophosphamide, Ixazomib, And Dexamethasone In Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and the best dose of cyclophosphamide when given together with ixazomib and dexamethasone in treating patients with previously untreated symptomatic multiple myeloma. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib and dexamethasone may be an effective treatment for multiple myeloma.
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PEA For The Relief Of Chemotherapy-Induced Peripheral Neuropathy
Eau Claire, WI; Rochester, MN
The purpose of this study the efectiveness of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN). Also, to assess the safety of PEA at the two study doses, and to evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.
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Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine As First-Line Treatment For Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), Or Low-Blast Acute Myelogenous Leukemia (AML)
Jacksonville, FL
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves overall response rate (ORR) by Cycle 6 and whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
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A Study To Evaluate The Effectiveness And Safety Of Panzyga In Patients With Chronic Lymphocytic Leukemia
Rochester, MN
The purpose of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in Chronic Lymphocytic Leukemia (CLL) patients with secondary immunodeficiency (SID) undergoing CLL antineoplastic therapy.
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A Study To Evaluate IMGN632 With Venetoclax And/or Azacitidine To Treat Patients With CD123-Positive Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is is to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in patients with relapsed and frontline CD123-positive AML, and antileukemia activity of IMGN632 when administered as monotherapy in patients with MRD+ AML after frontline treatment.
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Phase 3 Study Of MRTX849 With Cetuximab Vs Chemotherapy In Patients With Advanced Colorectal Cancer With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
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A Study To Investigate The Da Vinci SP® Surgical System In Colorectal Procedures For Benign And Malignant Disease
Jacksonville, FL; Rochester, MN
The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.
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A Study To Evaluate Duloxetine To Prevent Oxaliplatin-Induced Peripheral Neuropathy In Patients With Stage II-III Colorectal Cancer
Eau Claire, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
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Ascorbic Acid And Chemotherapy For The Treatment Of Relapsed Or Refractory Lymphoma, CCUS, And Chronic Myelomonocytic Leukemia
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells.
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Testing Whether The Addition Of Carboplatin Chemotherapy To Cabazitaxel Chemotherapy Will Improve Outcomes Compared To Cabazitaxel Alone In People With Castrate-Resistant Prostate Cancer That Has Spread Beyond The Prostate To Other Parts Of The Body
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN
The purpose of this study compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of ...
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Gemini Study To Evaluate The Integration Of Cancer Genetic Testing Into A Cancer Clinical Practice At Mayo Clinic At Arizona
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.
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A Study To Evaluate Carboplatin-paclitaxel With Retifanlimab Or Placebo In Participants With Locally Advanced Or Metastatic Squamous Cell Anal Carcinoma
Rochester, MN
The purpose of this study is to compare the effectiveness of Carboplatin-Paclitaxel with INCMGA00012 vs. Carboplatin-Paclitaxel with placebo in participants with inoperable, locally-advanced or metastatic Squamous Cell Anal Carcinoma (SCAC) not previously treated with systemic chemotherapy.
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Pertuzumab, Trastuzumab, Hyaluronidase-zzxf And Enzalutamide For The Treatment Of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study
Rochester, MN
This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an ...
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Group Meaning-Centered Psychotherapy For The Improvement Of Wellbeing In Caregivers Of Patients With Advanced Cancer
Jacksonville, FL; Rochester, MN
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual ...
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A Study Of Patients Undergoing Neoadjuvant Therapy For Resectable Non-small Cell Lung Cancer To Evaluate Perioperative Circulating Tumor DNA As A Prognostic Biomarker
Jacksonville, FL
The purpose of this study is to determine the validity of employing quantitative ctDNA as a surrogate marker for pathologic treatment response in patients receiving neoadjuvant therapy for Stage IIA-IIIB NSCLC undergoing curative-intent resection. We will assess the relationship between major pathologic response (≤10% viable tumor remaining) and percent change in levels of ctDNA concentration before and after neoadjuvant therapy.
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Prostate Imaging Using MRI +/- Contrast Enhancement
Rochester, MN
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.
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Endometrial Cancer/Endometrial Atypical Hyperplasia With An AI-based Classifier In Transvaginal Ultrasound In Patients With Post-Menopausal Bleeding
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to prospectively validate a new Artificial Intelligence (AI)-based model developed by our team to analyze TVUS images for early EC detection.
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A Study To Evaluate Visually Inspired Patient Education Material On Willingness To Pursue Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to measure how patient anxiety changes using a validated patient reported outcome measure, to measure radiotherapy completion rates in the American Indian/Alaska Native (AI/AN) community, and to measure patient perception of information received using a validated patient reported outcome measure.
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Clinical Trial Of The ATM-Inhibitor WSD0628 In Combination With Radiation Therapy For Recurrent Brain Tumors
Rochester, MN
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Rochester, MN
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with ...
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A Study To Evaluate Pevonedistat, Azacitidine (Or Decitabine), And Venetoclax (PAVE) To Treat Acute Myelogenous Leukemia (AML) Patients
Rochester, MN
The purpose of this study is to determine a recommended phase 2 dose (RP2D) of pevonedistat, azacitidine (or decitabine), and venetoclax to treat Acute Myelogenous Leukemia.
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A Study Evaluating Tolerability And Efficacy Of Navitoclax In Combination With Ruxolitinib In Subjects With Myelofibrosis
Jacksonville, FL
This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.
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Veliparib With Carboplatin And Paclitaxel And As Continuation Maintenance Therapy In Subjects With Newly Diagnosed Stage III Or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Rochester, MN
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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Radiation Therapy With Or Without Apalutamide In Treating Patients With Stage III-IV Prostate Cancer
Albert Lea, MN
The purpose of this study is to determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation therapy (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
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Genetic Testing With Family History Of Pancreatic Cancer
Jacksonville, FL
The purpose of this study is perform HOUSES index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria. A subset of 40 patients, who did not have appropriate NCCN intervention (the opportunity to have a genetic consultation to consider genetic testing) will prospectively be offered this opportunity. This subset of patients will also be surveyed on their family hisotry and knowledge and experiences of genetic consults/testing to better understand their decision-making when offered genetic counseling and testing.
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A Phase 2 Study Of CPI-0610 With And Without Ruxolitinib In Patients With Myelofibrosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of trhis study is to evaluate CPI-0610 in patients who have both received JAK inhibitors, such as ruxolitinib (Arms 1 and 2), and in patients who have never been treated with a JAK inhibitor (Arm 3). Patients who participate in Arm 1 will be treated with CPI-0610 alone (monotherapy arm), patients who participate in Arm 2 will be treated with CPI-0610 in combination with ruxolitinib (combination arm), and patients who have never been treated with a JAK inhibitor who participate in Arm 3, will also be treated with CPI-0610 and ruxolitinib, a JAK inhibitor (JAKi naïve arm).
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Rapid-Plan Knowledge-Based Planning Vs. Human-Driven Planning For Prostate Cancer Radiotherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) at 3 months post-radiotherapy for prostate cancer.
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A Study Of Unesbulin Combined With Dacarbazine To Treat Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The primary purpose of this study is to determine the maximum tolerated dose (MTD) and overall safety profile of PTC596 in combination with dacarbazine for the treatment of advanced Locally Recurrent, Unresectable or Metastatic Relapsed/Refractory Leiomyosarcoma (LMS).
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A Study To Compare Conventional Heart Echo Measurements With Newer 2 And 3 Dimensional Measurements Of Mechanical Heart Strain After Trastuzumab Infusion
Rochester, MN
The purpose of this study is to compare conventional assessment of systolic ventricular function on a 2D heart echo with an assessment of more immediate changes in heart mechanics using 2D and 3D measurements of deformation and strain in patients undergoing infusion of Trastuzumab for breast cancer.
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A Study to Evaluate Immune Response Changes to Ovarian Cancer During Chemotherapy
Rochester, MN
The study will determine whether the type and number of immune cells (white blood cells) in ovarian cancer tumors after initial chemotherapy impacts ovarian cancer patient outcomes.
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Decitabine In Combination With Standard Of Care Therapy For The Treatment Of Surgically Resectable HPV-Negative Head And Neck Cancer
Jacksonville, FL
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower ...
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Testing The Addition Of An Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery To The Usual Surgery Alone For Treating Advanced Skin Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may ...
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GATE1: A Multicenter Phase II Study Of Pirtobrutinib, Rituximab And Venetoclax Combination Therapy For Patients With Previously Untreated Mantle Cell Lymphoma
Rochester, MN
Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
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A Study Of MBG453 In Combination With Azacitidine And Venetoclax In AML Patients Unfit For Chemotherapy
Rochester, MN
This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment ...
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Comparison Of Standard Care With Radiation And Medicinal Therapy Vs Radiation Alone For Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Prostate cancer is one of the most prevalent malignancies affecting men worldwide, ranging from localized tumors to aggressive, metastatic disease (Siegel et al. 2023). An enormous array of treatments is available for treating prostate cancers, but the field faces a critical challenge in the lack of reliable biomarkers across the spectrum of disease that can direct treatment. This challenge is especially pressing in the current landscape where novel therapeutic approaches and personalized treatments are transforming prostate cancer for our patients.
This clinical trial aims to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular ...
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Radiation Therapy With Or Without Temozolomide In Treating Patients With Low-Grade Glioma
Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.
PURPOSE: This randomized phase III trial is studying radiation therapy ...
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A Study Investigating Integrated Genomics And Patient-derived Cancer Models
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The aim of this project is to characterize a landscape of DNA alterations and proteomic changes in both biopsies and resected tumors of patients which have been diagnosed with aggressive/metastatic disease to identify molecular targets for which therapeutic drugs may exist.
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A Study To Compare Three Chemotherapy Regimens For The Treatment Of Patients With Newly- Diagnosed Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib, and to determine how well they work in treating patients with newly-diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the ...
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Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB ...
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A Study To Compare Letrozole With Or Without Paclitaxel And Carboplatin In Treating Patients With Stage II-IV Ovarian Or Primary Peritoneal Cancer
Albert Lea, MN; Rochester, MN
The purpose of this study is to evaluate how well letrozole, with or without paclitaxel and carboplatin, works in treating patients with stage II-IV low-grade serous carcinoma of the ovary or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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Cardiotoxic Effects Of Chemotherapy In Patients With Sarcomas
Rochester, MN
The purpose of this study is to determine if two-dimensional speckle tracking echocardiography (2D-STE) derived-strain can detect early myocardial dysfunction and thus predict cardiotoxicity in sarcoma subjects undergoing anthracycline therapy and to compare three dimensional speckle tracking echocardiography (3D-STE) to 2D-STE in the same group of patients.
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A Phase 1/2 Trial Of Gemcitabine Plus Nab-paclitaxel With Or Without FG-3019 As Neoadjuvant Chemotherapy In Locally Advanced, Unresectable Pancreatic Cancer
Jacksonville, FL
This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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Venetoclax, Ixazomib Citrate, And Dexamethasone In Treating Patients With Relapsed Multiple Myeloma
Rochester, MN
This phase I/II trial studies the side effects and best dose of venetoclax when given together with ixazomib citrate and dexamethasone and to see how well they work in treating patients with multiple myeloma that has come back. Venetoclax and ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with ixazomib citrate and ...
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Idasanutlin, Ixazomib Citrate, And Dexamethasone In Treating Patients With Relapsed Multiple Myeloma
Jacksonville, FL; Rochester, MN
Does idasanutlin in combination with ixazomib and dexamethasone contribute to better outcomes for patients with multiple myeloma who have been previously treated for their disease?
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Duvelisib And Nivolumab For The Treatment Of Stage IIB-IVB Mycosis Fungoides And Sezary Syndrome
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in ...
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A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I), and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).
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A Study Of Biomarkers To Predict Cancer Therapy-related Cardiotoxicity
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to collect Biospecimens from patients who developed chemotherapy related cardiac toxicity (CRCT) and patients who are at a high risk for developing CRCT identified prior to the onset of therapy.
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Changes In Blood Components In Patients With Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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A Study To Evaluate The Efficacy And Safety Of Golcadomide In Combination With Rituximab In Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
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Confirmatory Study Of Topical HyBryte™ Vs. Placebo For The Treatment Of CTCL (FLASH2)
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
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Cisplatin And Etoposide Or Temozolomide And Capecitabine In Treating Patients With Neuroendocrine Carcinoma Of The Gastrointestinal Tract Or Pancreas That Is Metastatic Or Cannot Be Removed By Surgery
Rochester, MN
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current ...
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A Study Evaluating Temozolomide Vs. Temozolomide And Olaparib For Advanced Pheochromocytoma And Paraganglioma
Rochester, MN
The purpose of this study is to determine how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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Turkey Tail Mushroom For Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ
This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.
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Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
Rochester, MN
The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.
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Testing The Use Of Ado-Trastuzumab Emtansine Compared To The Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) For Recurrent, Metastatic, Or Unresectable HER2-Positive Salivary Gland Cancer
Rochester, MN
The purpose of this study is to test whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them.
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Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy In Previously Treated Advanced Or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations Or Other Genomic Alterations (MK-2870-004)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare MK-2870 to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations.
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A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, And Elotuzumab, Pomalidomide, And Dexamethasone Or Pomalidomide, Bortezomib, And Dexamethasone In Participants With Relapsed Or Refractory Myeloma Who Have Received An Anti-CD38 Antibody And Lenalidomide
Rochester, MN
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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The Role Of Cytomegalovirus And Inflammation On Patient Symptoms And Outcomes In Ovarian Cancer
Albert Lea, MN; Mankato, MN
The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.
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Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) For The Local Staging Of Rectal Cancer
Rochester, MN
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
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Study To Evaluate The Safety And Efficacy Of Magrolimab In Combination With Azacitidine Versus Physician's Choice Of Venetoclax In Combination With Azacitidine Or Intensive Chemotherapy In Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare the effectiveness of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).
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Evaluating Bladder CARE™, A New Non-Invasive Urine Test, For Bladder Cancer Detection In Inconclusive Cases
Rochester, MN
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:
• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?
Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), ...
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Testing Pump Chemotherapy In Addition To Standard Of Care Chemotherapy Versus Standard Of Care Chemotherapy Alone For Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
Rochester, MN
The purpose of this study is to compare hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable).
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A Study To Compare Mobile Health And Social Media Physical Activity Intervention Among Adolescent And Young Adult Childhood Cancer Survivors
Rochester, MN
The purpose of this study is to compare a mobile health and social media physical activity intervention versus wearing a physical activity tracker among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels ...
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A Study To Evaluate EAA181 To Treat Newly-diagnosed Multiple Myeloma
La Crosse, WI; Rochester, MN
The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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Reduced Dose Hypofractionated Radiotherapy For Indolent Non-hodgkin Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of thisstudy is to evaluate reduction of radiotherapy dose for patients with indolent NHL by conducting a prospective randomized phase 2 study comparing reduced dose hypofractionated ISRT of 9 Gy delivered over 3 fractions (BED 12 Gy) to standard of care 24 Gy delivered over 12 fractions (BED 29Gy), while simultaneously evaluating prognostic value of pre-radiation functional imaging parameters and molecular markers to predict treatment response and failure.
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Three-Dimensional Ultrasound in the Determination of Tumor Volume and Myometrial Invasion in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate sensitivity and specificity of 3D ultrasound in the assessment of tumor diameter and myometrial invasion in endometrial cancer in a pre-operative setting. This research is aiming to avoid the performance of sentinel node biopsy in patients at low risk of lymphatic spread.
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Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal ...
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Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
Scottsdale/Phoenix, AZ
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
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A Study to Compare Docetaxel/Prednisone to Docetaxel/Prednisone Combined with OGX-011 in Men with Prostate Cancer
Rochester, MN
The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone.
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A Study to Assess Anxiety Associated with Outpatient Visits in Pediatric Oncology Patients
Rochester, MN
The purpose of this study is to assess baseline anxiety experienced by children and their parents/guardians associated with outpatient visits in pediatric oncology. Assess coping mechanisms used by children and their parents/guardians to alleviate the anxiety associated with outpatient visits in pediatric oncology.
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Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Rochester, MN
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
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A Study To Assess The Effectiveness Of Osimertinib Plus Savolitinib In Patients With Locally Advanced Or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study) Following Prior Osimertinib
Rochester, MN
The purpose of this study (the SAVANNAH study) is tol investigate the effectiveness of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following treatment with osimertinib.
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A Study To Evaluate Gemcitabine Hydrochloride And Cisplatin With Or Without Nab-Paclitaxel In Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
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A Study To Evaluate Nasal Vestibulitis Symptoms In Patients Undergoing Systemic Antineoplastic Therapy
Albert Lea, MN; Austin, MN; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate treatment-emergent nasal vestibulitis symptoms in patients undergoing systemic antineoplastic therapy.
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A Study To Evaluate AuTophagy Activation For Cardiomyopathy Due To Anthracycline TReatment
Rochester, MN
The purpose of this study is to evaluate the additional benefit of pravastatin and spironolactone when given in combination with carvedilol and lisinopril versus carvedilol and lisinopril alone.
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A Study Of Catequentinib, Anlotinib In Metastatic Or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma And Synovial Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AL3818 (catequentibub, anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
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A Study Of Pomalidomide, Ixazomib Citrate, And Dexamethasone In Treating Patients With Previously Treated Multiple Myeloma Or Plasma Cell Leukemia
Rochester, MN
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
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MicroOrganoSphere Drug Screen Pilot Trial In Colorectal Cancer (CRC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14="">
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.
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S1406 A Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without ...
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Study Of Quemliclustat And Chemotherapy Versus Placebo And Chemotherapy In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.
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Colorectal Cancer Screening/Microbiome Collection
Jacksonville, FL
The purpose of this study is to evaluate the integration of cancer genetic testing into a cancer clinical practice aimed towards patients of various ethnic populations in Arizona and Florida – including, but not limited to, Hispanic/Latino, Native American/Alaskan, African American, and Asian by self-report.
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A Long Term Follow Up Of Mammography Screening
Rochester, MN
The purpose of this study is to execute a long-term retrospective observational cohort study of women who underwent screening mammography (defined as digital mammography or tomosynthesis).
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Virtual Dignity Therapy For Palliative Care Patients With Advanced Cancer
Rochester, MN
The purpose of this study is to determine if it is feasible to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer and whether the intervention is beneficial in terms of improvement in distress, patient dignity, and quality of life.
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A Study Of Lower Radiotherapy Dose To Treat Children With CNS Germinoma
Rochester, MN
The purpose of this study is to determine how well lower dose radiotherapy after chemotherapy (Carboplatin & Etoposide) works in treating children with central nervous system (CNS) germinomas.
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A Study To Determine The Effect Of Distance Reiki On Patient Reported Quality Of Life (PRQoL) And Immunity Among Multiple Myeloma Patients
Rochester, MN
This study aims to demonstrate acceptability and feasibility of the use of Distance Reiki therapy versus sham Reiki therapy among multiple myeloma patients.It also aims to determine if there is a minimal clinically meaningful improvement in various QOL domains (Physical, Social, Emotional), overall QOL with use of Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Single Item Linear Analogue Scale (LASA) after Distance Reik. Lastly, it aims to analyze the effect of Distance Reiki on expansion of the immune repertoire by comparing immune repertoires at baseline and at the end of the study by using Mass spectrometry by CyTOF® and multiplex ...
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GPS Compared With BAT In AML CR2/CR2p
Jacksonville, FL
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best
available treatment (BAT) in patients with AML in second complete remission (CR2)
or in second complete remission with incomplete platelet recovery (CRp2). All
patients will have their historical bone marrow samples stained for WT1 via IHC by
central pathology review. The primary goal of the study will be to demonstrate an
advantage for GPS in overall survival in these patient populations. The study will
enroll approximately 116 patients and will be conducted at up to 50 investigational
sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are
in CR2 or ...
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Transbronchial Biopsy Assisted By Robot Guidance In The Evaluation Of Tumors Of The Lung
Scottsdale/Phoenix, AZ
The primary objective of this trial is to determine safety of the robotic bronchoscopy procedures performed in routine clinical practice at multiple centers. Secondary objectives include overall safety assessment as well as description of diagnostic accuracy of the robotassisted bronchoscopy procedure.
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A Study Of I-DXd In Combination With Atezolizumab With Or Without Carboplatin As First-Line Induction Or Maintenance In Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of I-DXd in combination with immune checkpoint inhibitor atezolizumab with or without carboplatin in subjects with ES-SCLC in the first-line (1L) setting.
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Phase 1-2 Study Of Low Dose ASTX727 (ASTX727 LD) In Lower Risk Myelodysplastic Syndromes
Jacksonville, FL; Rochester, MN
The purpose of this study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 Myelodysplastic Syndromes (MDS). This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.
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A Study To Evaluate The Feasibility Of Memantine In Reducing Cognitive Impairment In Pediatric Patients After Radiation Therapy For Central Nervous System Tumors
Rochester, MN
The purpose of this study is to evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and continued one month after radiation therapy (RT), and to evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.
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Testing The Use Of Steroids And Tyrosine Kinase Inhibitors With Blinatumomab Or Chemotherapy For Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia In Adults
Rochester, MN
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
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A Study To Compare Early Use Of Vinorelbine And Maintenance Therapy For Patients With High Risk Rhabdomyosarcoma
Rochester, MN
This phase III trial compares the effect of vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide for the treatment of high risk rhabdomyosarcoma. Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vinorelbine and VAC may kill more tumor cells. Adding maintenance therapy (vinorelbine and cyclophosphamide) after VAC therapy, with or without vinorelbine, may help get rid of the cancer and/or ...
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Paclitaxel, Ifosfamide And Cisplatin (TIP) Versus Bleomycin, Etoposide And Cisplatin (BEP) For Patients With Previously Untreated Intermediate- And Poor-risk Germ Cell Tumors
Rochester, MN
The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.
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A Multicenter Study In Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence For Rapid Lung Cancer Detection - The ON-SITE Study
Jacksonville, FL
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
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Study Of Onvansertib In Combination With FOLFIRI And Bevacizumab Versus FOLFIRI And Bevacizumab For Second Line Treatment Of Metastatic Colorectal Cancer In Participants With A Kirsten Rat Sarcoma Virus Gene (KRAS) Or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Panitumumab, Regorafenib, Or TAS-102, In Treating Patients With Metastatic And/or Unresectable RAS Wild-Type Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is: negative for RAS wild-type colorectal cancer and has spread to other places in the body, and/or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the ...
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A Study To Compare Trilaciclib Versus Placebo In Patients Receiving FOLFOXIRI/Bevacizumab For Metastatic Colorectal Cancer
Rochester, MN
This study aims to evaluate the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.
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Breast MR
Rochester, MN
The purpose of this study is to examine the capability of contrast enhanced breast PCD-CT in staging breast cancer within the breasts and regional nodes of human subjects. Developing and using a PCD-CT imaging technique and postprocessing algorithms, dedicated for breast cancer detection.
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Effects Of A Hospitality Initiative On Referral Patterns For Native American Cancer Patients In Maricopa County
Scottsdale/Phoenix, AZ
The purpose of this study is to interview patients and providers at Phoenix Indian Medical Center and Mayo Clinic Arizona to identify perceptions, experiences, and perceived factors influencing referrals and enrollment on clinical trials in the Department of Radiation Oncology at Mayo Clinic Arizona.
The overall goal of this line of research is to enhance the hospitality, cultural responsiveness, and efficiency with which a leading cancer center can collaborate with a neighboring treatment hub for an important, underserved population within that cancer center’s catchment area.
American Indian and Alaska Native people experience higher rates of cancer ...
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Short-course Radiation Therapy For Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of 5 fraction stereotactic pencil beam scanning proton radiotherapy for the treatment of hepatocellular carcinoma (HCC).
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Metabolic Agents Pharmacodynamic Analyses After Brain Radiation
Rochester, MN
Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate). Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate).
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Venetoclax In Combination With ASTX727 For The Treatment Of Chronic Myelomonocytic Leukemia And Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts.
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Analyses Of Metabolic Agents Following Brain Radiation
Rochester, MN
The purpose of this study is to determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation.
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A Study Of Glofitamab And Lenalidomide In People With Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
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Empty Bladder Impact During Radiation Therapy For Prostate Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether an empty bladder during radiation therapy delivery for prostate cancer affects patient-reported urinary symptoms related to treatment.
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A Study To Compare Standard Chemotherapy To Therapy With CPX-351 And/or Gilteritinib To To Treat Newly-diagnosed AML With Or Without FLT3 Mutations
Rochester, MN
The purpose of this study is to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.
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A Study Using Clofarabine and Cytarabine in Treating Children with Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
No Locations
Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
The purpose of this trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
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Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well combination chemotherapy and pralatrexate works in treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
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A Study of Paclitaxel with or without Cixutumumab as Second-Line Therapy for Treating Patients with Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well paclitaxel, with or without cixutumumab, works for treating patients who have esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.
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Gemcitabine And Cisplatin As Neoadjuvant Chemotherapy In Patients With High-Grade Upper Tract Urothelial Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
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A Study To Evaluate Bleomycin, Carboplatin, Etoposide, Or Cisplatin In Treating Pediatric And Adult Patients With Germ Cell Tumors
Rochester, MN
The purpose of this study is to evaluate how well bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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Brightline-1: A Study To Compare Bi 907828 With Doxorubicin In People With A Type Of Cancer Called Dedifferentiated Liposarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer.
Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and ...
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Rochester, MN
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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Treatment Of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic or unresectable soft-tissue sarcoma patients. In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will ...
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Effect Of TTFields (150 KHz) In Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Observation Or Radiation Therapy In Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed By Surgery
Rochester, MN
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
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Lenalidomide Or Observation In Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
Rochester, MN
This phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk smoldering multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient.
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Long-Term Follow-Up Of Patients Who Have Participated In Children's Oncology Group Studies
Rochester, MN
This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.
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DNA Damage Using HERY-MNT Technology Can Predict Chemotherapy Induced Toxicity In Women With Ovarian Cancer
Rochester, MN
The purpose of this study is to understand changes that take place in the blood of patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This portion of the study is to understand the changes that occur in your blood during and after treatment with carboplatin and paclitaxel chemotherapy in women with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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A Study Of Performing Surgery For Resectable Malignant Pleural Mesothelioma After Radiation Therapy
Rochester, MN
The purpose of this study is to assess the possibility, safety, and therapeutic effect of administering a short, quick course of high-dose radiation treatment focused on half of the chest, followed by surgery to remove that portion of the lungs, in patients with malignant pleural mesothelioma.
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A Study Of Standard Systemic Therapy With Or Without Definitive Treatment In Treating Participants With Metastatic Prostate Cancer
Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to evaouate how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body.
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A Study To Evaluate 9-ING-41 As A Single Agent Or In Combination With Ruxolitinib In Myelofibrosis Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness of 9-ING-41, either by itself or in combination with Ruxolitinib, in patients with advanced myelofibrosis. 9-ING-41 has anti-cancer clinical activity while not causing myelosuppression, and has both pre-clinical anti-fibrotic activity and activity against myelofibrosis. 9-ING-41 may reduce the dose of Ruxolitinib needed for optimal therapeutic response and/or reverse myelosuppression so than an adequate dose of Ruxolitinib can be tolerated for an adequate duration to confer an optimal therapeutic outcome.
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A Study To Investigate The Safety And Tolerability Of Ziftomenib In Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, Or 7+3+Quizartinib In Patients With AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
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Study Of CG0070 Given In Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive To Bacillus-Calmette-Guerin
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the activity of intravesical (IVE) administration of Cretostimogene Grenadenorepvec in patients with tissue pathology confirmed non-muscule invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease.
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Musical Toxicity's Effect On Patient During Cancer Treatment
Rochester, MN
The purpose of this study is to produce a rich description of musicians’ experience as they go through cancer treatment and navigate recovery.
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Learning From Patients How They Were Educated On Chemotherapy Side Effects
Rochester, MN
To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).
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An Adjuvant Study To Evaluate SMS001 (Paclitaxel) In Non-Small Cell Lung Cancer
Rochester, MN
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
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A Study Of Carboplatin, Cabazitaxel And Abiraterone In High Volume Metastatic Castration Sensitive Prostate Cancer (CASCARA)
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine the proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria 1 year, with 6 cycles of carboplatin and cabazitazel followed by continued abiraterone.
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Testing The Addition Of M3814 (Peposertib) To Radiation Therapy For Patients With Advanced Head And Neck Cancer Who Cannot Take Cisplatin
Scottsdale/Phoenix, AZ
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
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A Study To Evaluate A Resilient Living Program For Patients With Advancer Cancer And Their Caregivers
Rochester, MN
The primary purpose of this study is to determine feasibility as measured by consent of at least 25% of eligible patients and their caregivers (defined as those who met with the study coordinator), adherence (75% of the enrolled participants will complete at least 3 of the 4 Resilient Living sessions), and acceptability (measured by ) of the delivery of the Resilient Living intervention to patients with advanced cancer and their caregivers.
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Pilot Study Of Care At Home For Monitoring Brain Tumor Patients
Rochester, MN
The purpose of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and selfreport assessments in clinical trial participants who have previously received cranial radiation.
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A Study Of The Drugs Selumetinib Vs. Carboplatin And Vincristine In Patients With Low-Grade Glioma
Rochester, MN
This study aims to demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).
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Study Of SX-682 Alone And In Combination With Oral Or Intravenous Decitabine In Subjects With Myelodysplastic Syndrome
Jacksonville, FL
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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A Study of Adding AMG 479 to First Line Chemotherapy in Patients with Optimally Debulked Epithelial Ovarian Cancer
Rochester, MN
The purpose of this study is to determine the value of adding AMG 479 (a fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin (first line chemotherapy) for the treatment of patients who have ovarian epithelial cancer that has been surgically removed to less than 1 cm thick.
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A Study Comparing Temozolomide and Selumetinib for Treating Patients with Metastatic Melanoma of the Eye
Rochester, MN
The purpose of this study is to compare the effectiveness of temozolomide to selumetinib for the treatment of patients who have melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.
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A Phase 1 Dose Escalation And Expansion Study Of TGR-1202 + Ruxolitinib In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF), Post-Essential Thrombocythemia MF (PET-MF), MDS/MPN, Or Polycythemia Vera Resistant To Hydroxyurea
Scottsdale/Phoenix, AZ
This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.
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A Trial To Find And Investigate A Safe Dose Of BI 836858 In Combination With Decitabine For Patients With Acute Myeloid Leukemia (AML)
Jacksonville, FL
Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
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A Study Designed To Evaluate The Safety And Efficacy Of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) In Participants With T(11;14)-Positive Relapsed Or Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.
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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
Rochester, MN
This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Rochester, MN
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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Auranofin And Sirolimus In Treating Participants With Ovarian Cancer
Rochester, MN
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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A Study Of The Gut Microbiome In Chemotherapy Treatment
Rochester, MN
The purpose of this study is to investigate the impact of microbiome on the effectiveness and toxicity of anti-cancer therapy and to develop microbiome- based markers to personalize cancer treatment.
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A Trial Of Enzastaurin Plus Temozolomide During And Following Radiation Therapy In Patients With Newly Diagnosed Glioblastoma With Or Without The Novel Genomic Biomarker, DGM1
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.
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A Study To Analyze Onvansertib Treatment In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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NRG-GY012 “A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, And The Combinations Of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5356 (Capivasertib) In Women With Recurrent, Persistent Or Metastatic Endometrial Cancer. A Multi-Arm Trial For Women With Recurrent Or Persistent Endometrial Cancer”
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The purpose of this randomized phase II trial study is to determine how well olaparib, cediranib maleate, and Week 1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study Of The Diagnostic Performance Of The Nonlinear Elasticity Parameter Mapping Method With Suspicious Breast Masses
Rochester, MN
The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.
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Study To Compare The Safety And Effectiveness Of Treatment Combinations In Patients With Recurrent Ovarian Cancer
Rochester, MN
The primary purpose of this study is to evaluate the effectiveness of the niraparib combinations defined in each cohort-specific supplement, as assessed by confirmed objective response rate (ORR), in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
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A Vaccine (H2NVAC) Before Surgery For The Treatment Of HER2-Expressing Ductal Carcinoma In Situ
Jacksonville, FL; Rochester, MN
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
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A Study to Explore MRI to Stage Bladder Cancer
Jacksonville, FL
The purposes of this study are to assess image quality of a multiparametric MRI protocol for local staging imaging among patients with bladder cancer, and to assess accuracy of MR imaging in determining muscle invasion.
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Deep Learning-based Automated Segmentation of Organs at Risk in Treat Head and Neck Radiotherapy
Rochester, MN
The purpose of this study is to validate the ability of GHMCA to produce expert-level contouring on retrospective Mayo data with a considerable time savings benefit.
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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.
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A Phase III, Randomised Study Of Adjuvant Dato-DXd In Combination With Rilvegostomig Or Rilvegostomig Monotherapy Versus Standard Of Care, Following Complete Tumour Resection, In Participants With Stage I Adenocarcinoma NSCLC Who Are CtDNA-positive Or Have High-risk Pathological Features
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
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A Safety And Efficacy Study Of Treatment Combinations With And Without Chemotherapy In Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).
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A Study To Evaluate Contouring Organs At Risk For Treatment Planning
Rochester, MN
The purpose of this study is to determine: if the artificial intelligence (AI)-generated results are less arduous than manual tracing by radiation oncologist, and the non-inferiority of the quality of AI vs. manual tracing. These aims will be evaluated in a clinical environment to investigate the impact of an AI algorithm on the clinical workflow.
Radiotherapy treatment planning requires precise calculations of radiation exposure, not only for the target volumes (tissue containing malignancy), but of nearby organs-at-risk (OARs), in which the exposure needs to be minimized. Manual segmentation of these organs is a time-consuming task with high interobserver variability. Producing these segmentations ...
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Analysis Of Live Tumor Fragments Of Surgical Resections
Jacksonville, FL
The purpose of this study is to obtain unused resected tumor tissue sample and associated clinical data from patients enrolled in this study to research ex vivo treatment response and integrity of tumor microenvironment using omics analysis and imaging while maintaining cell stability in a live environment.
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A Study To Evaluate Artificial Intelligence-driven Assistance For Treatment Planning In Radiation Oncology
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the innovations under development for an AI-augmented service platform software are desirable for customers, viable for stakeholders, and feasible to build and deliver, a multi-disciplinary design team will conduct human-centered design research. The results of this research will help the team design, develop, build, and improve current and future products and services.
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Cervical Cancer Screening Among Populations With Health Disparities
Rochester, MN
The purpose of this study is to conduct a survey of Somali and Hispanic women to ascertain personal, cultural, and structural barriers to CCS and assess the acceptability, and appropriateness of community engaged and community-based strategies to increase screening.
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Methadone Versus Intrathecal Hydromorphone For Analgesia Patients Undergoing Surgery For Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Rochester, MN
The purpose of this study is to determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone. Our overall purpose is to identify the most effective and least invasive manner in which to achieve adequate postoperative analgesia in patients undergoing major gynecologic oncological surgery.
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Fucoidan For Patients With Chemotherapy-Related Fatigue
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of fucoidan vs. placebo in preventing fatigue as assessed by a single-item measure of fatigue (Appendix 1, Linear Analog Scale of Fatigue) at 8 weeks following the initiation of platinum-based doublet/triplet.
The Fucoidan dose of 400 mg formulation is specifically being made for this trial.
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A Study Of ALX148 With Azacitidine For Higher Risk Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
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Olaparib In Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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AKT Inhibitor MK2206, Combined with Bendamustine Hydrochloride, and Rituximab for Treating Patients who have Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
The purpose of this study is is to assess the side effects and best dose of akt inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab, and to see how well they work in treating patients with treatment resistant chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, ...
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SC16LD6.5 in Recurrent Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of ...
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Durvalumab+/- Tremelimumab In Combination With Platinum Based Chemotherapy In Untreated Extensive-Stage Small Cell Lung Cancer (Caspian)
Scottsdale/Phoenix, AZ
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer.
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Bendamustine Hydrochloride And Rituximab With Or Without Bortezomib Followed By Rituximab With Or Without Lenalidomide In Treating Patients With High-Risk Stage II, Stage III, Or Stage IV Follicular Lymphoma
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and ...
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A Study To Test The Addition Of The Drug Cabozantinib To Chemotherapy In Patients With Newly Diagnosed Osteosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill ...
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Study Of ADI-PEG 20 Or Placebo Plus Gem And Doc In Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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Comparing Retreatment Of 177Lu-DOTATATE PRRT Versus Everolimus In Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is tol compare the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable).
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Study Of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) In Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy In Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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A Study To Evaluate Whether Participants With Melanoma Prefer Subcutaneous Vs Intravenous Administration Of Nivolumab And Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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IMC-F106C Regimen Versus Nivolumab Regimens In Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Jacksonville, FL
The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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An Investigational Immuno-therapy Study Of Nivolumab, Compared To Placebo, In Patients With Bladder Or Upper Urinary Tract Cancer, Following Surgery To Remove The Cancer
Rochester, MN
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
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A Study Of APR-246 And Pembrolizumab In Patients With Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
La Crosse, WI
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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A Phase 1b Trial Of ATRC-101 In Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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A Study To Evaluate Adjuvant Ado-Trastuzumab Emtansine (T-DM1) In HER2 Positive Breast Cancer
Rochester, MN
The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)
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Study Of Trastuzumab Deruxtecan (T-DXd) Vs Investigator's Choice Chemotherapy In HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.
In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
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A Study To Evaluate The Addition Of Immunotherapy Into Adjuvant Therapy For Non-small Cell Lung Cancer
Rochester, MN
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...
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Novel SEQUEnced Immunotherapy With Anti-angiogenesis And Chemotherapy In Advanced GastroesophageaL Adenocarcinoma (SEQUEL)
Rochester, MN
This is a randomized Phase 2 study of novel SEQUEnced immunotherapy (pembrolizumab) with anti-angiogenesis and chemotherapy in advanced gastric and gastroesophageaL junction (GEJ) adenocarcinoma (SEQUEL) designed to to evaluate the best overall response rate (BORR) of combined ramucirumab (RAM) plus paclitaxel (+/- pembrolizumab) following induction pembrolizumab (PEM) in patients with advanced gastric and GEJ adenocarcinoma.
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Study Of Datopotamab Deruxtecan (Dato-DXd) In Combination With Durvalumab And Carboplatin For First-Line Treatment Of Patients With Advanced NSCLC Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
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Phase 3 Study Of PDS0101 And Pembrolizumab In HPV16+ Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.
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A Study To Evaluate Exercise For Cancer Patients At Risk Of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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An Adjuvant Endocrine-based Therapy Study Of Camizestrant (AZD9833) In ER+/HER2- Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess if camizestrant improves outcomes compared to standard endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).
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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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Oncolytic Adenovirus Coding For TNFa And IL2 (TILT-123) With Pembrolizumab Or Pembrolizumab And Pegylated Liposomal Doxorubicin As Treatment For Ovarian Cancer. (PROTA)
Rochester, MN
The purpose of this study is to evaluate the safety [including dose-limiting toxicities (DLTs)] of the combination therapy of TILT-123 and pembrolizumab in patients with platinum resistant or refractory ovarian cancer.
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Testing The Addition Of MEDI4736 (Durvalumab) To Chemotherapy Before Surgery For Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery ...
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib And Nivolumab) To Treat Patients With Advanced Melanoma Or Squamous Cell Head And Neck Cancer, An ImmunoMATCH Pilot Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete ...
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Diet in Altering Disease Progression in Patients with Prostate Cancer on Active Surveillance
Rochester, MN
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
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A Study Of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy For Advanced Non-Small Cell Lung Cancer (MK-3475-495)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with ...
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Ipilimumab With Or Without Talimogene Laherparepvec In Unresected Melanoma
Jacksonville, FL
Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.
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A Study To Determine The Outcomes Of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy
Rochester, MN
AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).
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A Study To Evaluate The Safety And Effectiveness Of Pembrolizumab Compared To Placebo In Resected High-risk Stage II Melanoma Patients
Jacksonville, FL; Rochester, MN
The purpose of this 2-part study is to evaluate the safety and effectiveness of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of ...
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A Study Of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Rochester, MN
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
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A Study To Evaluate RP1 Monotherapy And Combined With Nivolumab
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.
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A Study To Evaluate The Safety And Efficacy Of Two Dose Levels Of ONO-4578 With Opdivo®, In Combination With MFOLFOX6 And Bevacizumab Versus Standard Of Care In Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
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A Study To Evaluate The Effectiveness And Safety Of Pembrolizumab Combined With Bacillus Calmette-Guerin In High-Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction or that is naïve to BCG treatment.
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Study Of Pembrolizumab (MK-3475) As Monotherapy In Participants With Previously-Treated Locally Advanced Unresectable Or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
Rochester, MN
In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan ...
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Oral Tamoxifen Vs. TamGel Vs. Control In Women With Atypical Hyperplasia Or Lobular Carcinoma In Situ
Rochester, MN
The purpose of this study is to analyze breast tissue changes after a short course of Tamoxifen (Tam).
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A Study To Measure The Proteins Expressed In Tissue Samples From Women Who Have Been Treated With New Endocrine Therapy For Invasive Lobular Breast Cancer
Rochester, MN
The purpose of this study is to compare the effectiveness of fulvestrant to anastrozole or tamoxifen in treating invasive lobular breast cancer, by measuring the level of the biomarker Ki67 found in tumor tissue before and then after treatment.
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A Study Of Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
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Study Of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) In Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy In Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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A Study To Evaluate Whether Participants With Melanoma Prefer Subcutaneous Vs Intravenous Administration Of Nivolumab And Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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IMC-F106C Regimen Versus Nivolumab Regimens In Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Jacksonville, FL
The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
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A Study Of APR-246 And Pembrolizumab In Patients With Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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An Investigational Immuno-therapy Study Of Nivolumab, Compared To Placebo, In Patients With Bladder Or Upper Urinary Tract Cancer, Following Surgery To Remove The Cancer
Rochester, MN
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
La Crosse, WI
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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A Phase 1b Trial Of ATRC-101 In Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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Study Of Trastuzumab Deruxtecan (T-DXd) Vs Investigator's Choice Chemotherapy In HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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A Study To Evaluate Adjuvant Ado-Trastuzumab Emtansine (T-DM1) In HER2 Positive Breast Cancer
Rochester, MN
The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)
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Virtual Mindfulness And Weight Management Program In Patients With Cancer Histories
La Crosse, WI
The purpose of this study is to improve well-being and promote weight loss using a virtual mindfulness and activity promotion program among rural patients with a history of cancer.
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BCG In Combination With Durvalumab In Adult BCG-naïve, High-risk NMIBC Participants (PATAPSCO)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of durvalumab (1500 mg iv for 13 cycles every four weeks (q4w) + BCG (induction and maintenance) combination therapy by assessment of Grade 3/4 PRAEs in high-risk NMIBC participants.
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A Randomized Phase 2 Study Of Combination Atezolizumab And CDX-1127 (Varlilumab) With Or Without Addition Of Cobimetinib In Previously Treated Unresectable Biliary Tract Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the response rate (ORR) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib, and to assess the progression free survival (PFS) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
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Study Of Adjuvant Cemiplimab Versus Placebo After Surgery And Radiation Therapy In Patients With High Risk Cutaneous Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study is to compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT -To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT; to compare the effect of adjuvant cemiplimab with that of placebo on patients' ...
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A Study To Evaluate Pembrolizumab Combined With Intensive Chemotherapy To Treat Patients With Acute Myeloid Leukemia
Jacksonville, FL
The purpose of this study is to determine how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving induction chemotherapy with pembrolizumab may work ...
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Prehabilitation
Rochester, MN
Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.
It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer ...
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Neoadjuvant Pembrolizumab
Rochester, MN
This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a type of immunotherapy that may enhance the ability of the immune system to fight off cancer. The study will investigate the effects of pembrolizumab on the immune system and how certain immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab. Previous studies suggest that pembrolizumab could alter the immune cells in a way that the the immune cells identify cancer ...
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A Phase 2b Clinical Study With A Combination Immunotherapy In Newly Diagnosed Patients With Glioblastoma - The ImmuneSense Study
Jacksonville, FL
The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma multiforme (GBM) participants treated with IGV-001 as compared with placebo.
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A Study To Test Adding Pembrolizumab To Olaparib Alone As Therapy For Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary purpose of this study is to evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
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Phase Ib/II Of TG4001 And Avelumab In HPV16 Positive R/M Cancers
Jacksonville, FL; Rochester, MN
The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic ...
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A Study Testing The Effect Of Immunotherapy (Ipilimumab And Nivolumab) In Patients With Recurrent Glioblastoma With Elevated Mutational Burden
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma ...
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A Study To Assess The Safety And Tolerability Of Atezolizumab In Combination With Other Immune-Modulating Therapies In Participants With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent ...
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A Study to Explore the Effects of the Measles Virus on Tumor Immunity
Rochester, MN
The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.
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A Study To Evaluate The Safety, Tolerability, And Determine The Optimal Dose For The Expansion Cohorts Of VSV-IFNβ-NIS In Combination With Pembrolizumab In Patients With Refractory Solid Tumors
Rochester, MN
The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).
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A Study Of Neoadjuvant/Adjuvant Durvalumab For The Treatment Of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
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MC200404, Safety And Immunogenicity Of PolyPEPI1018 Vaccine In The Treatment Of Late-stage Metastatic Colorectal Cancer
Rochester, MN
The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.
PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.
Participants will receive TAS-102 and PolyPEPI1018 which ...
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A Study to Evaluate the Epidemiology of Estrogen Genotoxicity in Breast Cancer
Rochester, MN
The purpose of this study is to recruit 2000 incident cases of primary breast cancer in order to perform laboratory assays to measure frequencies of genetic polymorphisms for genes that encode enzymes involved in candidate gene pathways, including: estrogen and catecholestrogen formation, bioactivation and inactivation, cellular proliferation and apoptosis, nuclear factor kappa-beta; to compare genotype frequencies for polymorphisms of genes in breast cancer cases and controls, and to evaluate possible interactions among common polymorphisms in candidate genes.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
La Crosse, WI
The purpose of this research is to determine if previously adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone.
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Role Of Immunity In Efficacy Of Chemotherapy Plus Trastuzumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate T cell and antibody immunity in patients with HER2+ breast cancer who will receive trastuzumab with standard chemotherapy in order to address whether the immunity is associated with the patient’s response to treatment.
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A Study to Continue A Long Term Follow-Up of Patients Given Doxorubicin-Cyclophosphamide Therapy for Breast Cancer
La Crosse, WI
The purpose of this study is to continue with a long term follow-up of previously enrolled people treated with doxorubicin-cyclophosphamid followed by paclitaxel or docetaxel for axillary node-positive or high risk node-negative breast cancer.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Non-squamous NSCLC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
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Etigilimab And Nivolumab In Subjects With Locally Advanced Or Metastatic Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors.
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177Lu-DTPA-Omburtamab Radioimmunotherapy ToTreat Recurrent Or Refractory Medulloblastoma
Rochester, MN
The purpose of this study is to assess 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3, to treat children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy.
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A Study Of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) In Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel In Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)
Scottsdale/Phoenix, AZ
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).
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Study Of Oraxol And Pembrolizumab In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine dose escalation of paclitaxel administered as Oraxol in combination with Pembrolizumab, and dose expansion to assess the ORR per Response Evaluation Criteria in subjects with advanced Solid Tumors, Urothelial Carcinoma, Gastric cancer, Gastro-esophageal cancer, and Non-small cell lung cancer.
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Methotrexate, Erlotinib, And Celecoxib For The Treatment Of Recurrent/Metastatic Oral Cavity Cancer In A Rural Midwest United States Population
Albert Lea, MN; La Crosse, WI; Rochester, MN
This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by ...
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A Study Of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy In Patients With Resectable Stage II, IIIA, Or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
Rochester, MN
This is a randomized, double-blinded study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.
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A Study Of Cell, Serum, And Bone Marrow Bank For Patients Receiving Chimeric Antigen Receptor T Cell Therapy For The Treatment Of Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to store blood, serum and bone marrow so that they can be used for laboratory studies that may contribute to finding the exact function of the CART cells or T-cell engager therapy such as bispecific and trispecific antibodies and the factors that may determine disease progression and treatment response.
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A Study To Evaluate Effectiveness And Quality Of Life Outcomes Of Daratumumab In Relapsed/Refractory Multiple Myeloma Patients
Rochester, MN
The primary purpose of this study is to evaluate patient-reported health-related quality of life outcomes in subjects with Relapsed/Refractory Multiple Myeloma (RRMM) treated with daratumumab-based regimens in a real life setting.
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Chemotherapy Combined With Immunotherapy Vs Immunotherapy Alone For Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Eau Claire, WI; Mankato, MN
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
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A Study To Evaluate Firstline Pembrolizumab Alone Or In Combination With Pemetrexed And Carboplatin In Induction/Maintenance Or Postprogression In Treating Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...
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A Study Evaluating Pembrolizumab And Epacadostat In Treating Participants With Recurrent, Persistent, Or Progressive Ovarian Clear Cell Carcinoma
Rochester, MN
The purpose of this trial is to assess how well pembrolizumab and epacadostat work in treating participants with ovarian clear cell carcinoma that has come back, remains despite treatment, or is growing, spreading, or getting worse. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better in treating participants with ovarian clear cell carcinoma.
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ACP-196 In Combination With Pembrolizumab, For Treatment Of Hematologic Malignancies
Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety profile of acalabrutinib and pembrolizumab in subjects with hematologic malignancies.
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IL-2 Plus FOLFOX And Nivolumab For Treatment Of Peritoneal Metastases
Rochester, MN
The purpose of this study is to evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment.
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Avelumab With Binimetinib, Sacituzumab Govitecan, Or Liposomal Doxorubicin In Treating Patients With Stage IV Or Unresectable, Recurrent Triple Negative Breast Cancer
Rochester, MN
The purpose of this study is to evaluate how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent).
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An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to offer pre-approval drug access of iniparib combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Mankato, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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Study Of TBio-6517, Given Intratumorally, Alone Or In Combination With Pembrolizumab, In Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
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A Study of the Safety and Effectiveness of Nivolumab for the Treatment of Advanced Non-Small Cell Lung Cancer
Jacksonville, FL
The purpose of this study is to determine whether nivolumab alone or in combination with standard of care therapies will provide clinical benefit without unacceptable toxicity for the treatment of advanced non-small cell lung cancer patients.
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Predicting Immunotherapy Response In Metastatic Kidney Cancer
Rochester, MN
Immunotherapy has revolutionized the therapeutic landscape for patients with metastatic RCC and response rates are higher than previously observed with tyrosine kinase inhibitors. Despite this, there is a growing need for molecular markers that can help identify patients who will benefit from immunotherapy, especially in the landscape of multiple available regimens, potential toxicities and financial burden. In this study, we propose to use blood biopsies to study tumor-derived extracellular vesicles (tdEVs) to assess disease burden, monitor response to therapy, and to predict earlier disease progression. In addition to tdEVs, these samples will also be analyzed for other biomarkers ...
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A Study Using A New Drug, Nivolumab, In Combination With Chemotherapy Drugs To Treat A Type Of Cancer Called Nasopharyngeal Carcinoma (NPC)
Rochester, MN
This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer ...
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Study Of RP-3500 With Niraparib Or Olaparib In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.
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A Study Of Physical Activity In Cancer Survivors
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
The purpose of this study is to determine if to increasing physical activity (PA) will increase physical functioning, as measured by cardiovascular endurance, muscular strength, and balance in underserved adult cancer survivors of ages 18 or older residing at a rural address. Also, to deternube if increasing PA will increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors ages 18 or older residing at a rural address.
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Futibatinib And Pembrolizumab For The Treatment Of Advanced Or Metastatic FGF19 Positive BCLC Stage A, B, Or C Liver Cancer
Rochester, MN
This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell ...
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Bemarituzumab Plus Chemotherapy And Nivolumab Versus Chemotherapy And Nivolumab Alone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.
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A Study Of Subcutaneous Nivolumab + Relatlimab FDC In Previously Untreated Metastatic Or Unresectable Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate pharmacokinetic non-inferiority for nivolumab + relatlimab FDC SC (fixed-dose combination for subcutaneous administration) formulation versus nivolumab + relatlimab FDC IV formulation.
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Effectiveness And Safety Of Pembrolizumab For Participants With Resectable Stage IIB Or IIIA Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
This trial will evaluate the safety and effectiveness of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).
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A Phase 2 Study Of Atezolizumab (An Engineered Anti-PDL1 Antibody) As Monotherapy Or In Combination With Avastin (Bevacizumab) Compared To Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma [IMmotion150]
Jacksonville, FL
This multicenter, randomized, open-label study will evaluate the efficacy and safety of atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma. Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab alone (until disease progression), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progression, patients in Arms B and ...
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Atezolizumab Immunotherapy In Patients With Advanced NSCLC (AJCC 7th Edition)
Scottsdale/Phoenix, AZ
Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC (AJCC 7th Edition) eligible for chemoradiotherapy with curative intent.
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A Study to Analyze The Impact of Pharmacist Consultation in Patients Beginning Intravenous Cancer Treatment
La Crosse, WI
The purpose of this study is to assess the impact of pharmacist consultation in patients receiving first dose, first cycle intravenous cancer treatment on patient understanding of the cancer treatment, adverse drug events, and adherence. Additionally, this study will report the frequency of healthcare utilization for side effect management.
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A Study To Evaluate The Effect Of Canakinumab Or Pembrolizumab Given As Monotherapy Or In Combination As Neo-adjuvant Treatment For Subjects With Early Stages NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effect of canakinumab or pembrolizumab as monotherapy or combined as neo-adjuvant treatment for subjects with early stage non-small cell lung cancer.
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Analysis Of Letrozole In Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer
Jacksonville, FL
The purpose of this study is to study to collect tissue samples from patients with early stage hormone receptor-positive HER2-negative breast cancer.
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A Study To Evaluate The Immune Response To Anti-HER2 Therapies
Jacksonville, FL
The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.
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A Study To Evaluate At Home Administration Of Pertuzumab Combined With Trastuzumab To Treat Patients With HER2-Positive Breast Cancer During COVID-19 Pandemic
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.
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A Study To Evaluate LY3484356 Alone Or Combined With Anticancer Therapies To Treat Patients With Breast Or Endometrial Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the recommended Phase 2 dose (RP2D) of LY3484356 administered as monotherapy and in combination with other anticancer therapies in patients with locally advanced or metastatic ER+ breast cancer or ER+ recurrent, persistent, or metastatic endometrial endometrioid cancer (EEC).
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Comparison Of Operation To Monitoring With/Without Endocrine Therapy For Low Risk DCIS
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.
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Cisplatin With Or Without Veliparib In Treating Patients With Recurrent Or Metastatic Triple-Negative And/or BRCA Mutation-Associated Breast Cancer With Or Without Brain Metastases
Eau Claire, WI; La Crosse, WI; Rochester, MN
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back or has or has not spread to the brain. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more ...
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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.
The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries ...
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Study Of CG0070 Given In Combination With Pembrolizumab, In Non Muscle Invasive Bladder Cancer, Unresponsive To Bacillus Calmette-Guerin
Rochester, MN
The primary purpose of this study is to evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or without Ta/T1 papillary disease.
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Study Of Relacorilant In Combination With Pembrolizumab For Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production
Rochester, MN
The purpose of this study is to investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for patients with Adrenocortical Carcinoma with Excess Glucocorticoid Production.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
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A Study Of Copanlisib And Nivolumab In Treating Participants With Recurrent Or Refractory Diffuse Large B-cell Lymphoma Or Primary Mediastinal Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate how well copanlisib and nivolumab work in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back or does not responded to the treatment. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
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Study Of Pembrolizumab (MK-3475) Combination Therapies In Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.
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A Study Of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared To Pembrolizumab Alone In People With Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...
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Study Comparing Tarlatamab And Durvalumab Versus Durvalumab Alone In First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide And Durvalumab (DeLLphi-305)
Rochester, MN
The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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Pembrolizumab And Lenvatinib In Clear Cell Ovarian Cancer
Rochester, MN
The purpose of this trial is to investigate the clinical effectiveness of the combination of pembrolizumab and lenvatinib in patients with recurrent or persistent clear cell carcinoma of the ovary (CCOC) as measured by the multiple primary endpoints of objective response rate (ORR) and rate of PFS at 6 months (PFS6) per RECIST 1.1.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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An Expansion Study To Evaluate Dose Escalation, Safety And Tolerability Of SAR444881 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...
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Single Arm Pilot Trial Of Adaptive Therapy (AT) With Capecitabine For The Treatment Of Breast Cancer
Scottsdale/Phoenix, AZ
In this study, we propose a new way of giving chemotherapy, called Adaptive Therapy (AT) using capecitabine. The goal is to prove feasibility as well as safety of this approach. We will test adaptive therapy in 35 metastatic breast cancer patients diagnosed with ER+ disease but for whom endocrine therapies have failed and use of chemotherapy is appropriate. We will recruit participants at Mayo Clinic Arizona. Chemotherapy will be given orally in an adaptive fashion, which means we will adjust the dose of the chemotherapy according to the response of the tumor. Response is measured by imaging done ...
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Mankato, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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Study Of TBio-6517, Given Intratumorally, Alone Or In Combination With Pembrolizumab, In Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
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A Study of the Safety and Effectiveness of Nivolumab for the Treatment of Advanced Non-Small Cell Lung Cancer
Jacksonville, FL
The purpose of this study is to determine whether nivolumab alone or in combination with standard of care therapies will provide clinical benefit without unacceptable toxicity for the treatment of advanced non-small cell lung cancer patients.
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Predicting Immunotherapy Response In Metastatic Kidney Cancer
Rochester, MN
Immunotherapy has revolutionized the therapeutic landscape for patients with metastatic RCC and response rates are higher than previously observed with tyrosine kinase inhibitors. Despite this, there is a growing need for molecular markers that can help identify patients who will benefit from immunotherapy, especially in the landscape of multiple available regimens, potential toxicities and financial burden. In this study, we propose to use blood biopsies to study tumor-derived extracellular vesicles (tdEVs) to assess disease burden, monitor response to therapy, and to predict earlier disease progression. In addition to tdEVs, these samples will also be analyzed for other biomarkers ...
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A Study Using A New Drug, Nivolumab, In Combination With Chemotherapy Drugs To Treat A Type Of Cancer Called Nasopharyngeal Carcinoma (NPC)
Rochester, MN
This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer ...
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Study Of RP-3500 With Niraparib Or Olaparib In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.
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A Study Of Physical Activity In Cancer Survivors
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
The purpose of this study is to determine if to increasing physical activity (PA) will increase physical functioning, as measured by cardiovascular endurance, muscular strength, and balance in underserved adult cancer survivors of ages 18 or older residing at a rural address. Also, to deternube if increasing PA will increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors ages 18 or older residing at a rural address.
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Futibatinib And Pembrolizumab For The Treatment Of Advanced Or Metastatic FGF19 Positive BCLC Stage A, B, Or C Liver Cancer
Rochester, MN
This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell ...
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Bemarituzumab Plus Chemotherapy And Nivolumab Versus Chemotherapy And Nivolumab Alone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.
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A Study Of Subcutaneous Nivolumab + Relatlimab FDC In Previously Untreated Metastatic Or Unresectable Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate pharmacokinetic non-inferiority for nivolumab + relatlimab FDC SC (fixed-dose combination for subcutaneous administration) formulation versus nivolumab + relatlimab FDC IV formulation.
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A Study to Analyze The Impact of Pharmacist Consultation in Patients Beginning Intravenous Cancer Treatment
La Crosse, WI
The purpose of this study is to assess the impact of pharmacist consultation in patients receiving first dose, first cycle intravenous cancer treatment on patient understanding of the cancer treatment, adverse drug events, and adherence. Additionally, this study will report the frequency of healthcare utilization for side effect management.
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A Phase 2 Study Of Atezolizumab (An Engineered Anti-PDL1 Antibody) As Monotherapy Or In Combination With Avastin (Bevacizumab) Compared To Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma [IMmotion150]
Jacksonville, FL
This multicenter, randomized, open-label study will evaluate the efficacy and safety of atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma. Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab alone (until disease progression), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progression, patients in Arms B and ...
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Atezolizumab Immunotherapy In Patients With Advanced NSCLC (AJCC 7th Edition)
Scottsdale/Phoenix, AZ
Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC (AJCC 7th Edition) eligible for chemoradiotherapy with curative intent.
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Effectiveness And Safety Of Pembrolizumab For Participants With Resectable Stage IIB Or IIIA Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
This trial will evaluate the safety and effectiveness of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).
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A Study To Evaluate The Effect Of Canakinumab Or Pembrolizumab Given As Monotherapy Or In Combination As Neo-adjuvant Treatment For Subjects With Early Stages NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effect of canakinumab or pembrolizumab as monotherapy or combined as neo-adjuvant treatment for subjects with early stage non-small cell lung cancer.
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Analysis Of Letrozole In Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer
Jacksonville, FL
The purpose of this study is to study to collect tissue samples from patients with early stage hormone receptor-positive HER2-negative breast cancer.
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A Study To Evaluate The Immune Response To Anti-HER2 Therapies
Jacksonville, FL
The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.
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A Study To Evaluate At Home Administration Of Pertuzumab Combined With Trastuzumab To Treat Patients With HER2-Positive Breast Cancer During COVID-19 Pandemic
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.
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A Study To Evaluate LY3484356 Alone Or Combined With Anticancer Therapies To Treat Patients With Breast Or Endometrial Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the recommended Phase 2 dose (RP2D) of LY3484356 administered as monotherapy and in combination with other anticancer therapies in patients with locally advanced or metastatic ER+ breast cancer or ER+ recurrent, persistent, or metastatic endometrial endometrioid cancer (EEC).
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Comparison Of Operation To Monitoring With/Without Endocrine Therapy For Low Risk DCIS
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.
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Cisplatin With Or Without Veliparib In Treating Patients With Recurrent Or Metastatic Triple-Negative And/or BRCA Mutation-Associated Breast Cancer With Or Without Brain Metastases
Eau Claire, WI; La Crosse, WI; Rochester, MN
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back or has or has not spread to the brain. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more ...
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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.
The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries ...
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Specialty Compared To Oncology Delivered Palliative Care For Treating Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is to evaluate whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
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A Study Of Three-dimensional (3-D) Tissue Models In Patients With Serous Endometrial Cancer Planning To Undergo Surgery
Jacksonville, FL; Rochester, MN
The purpose of this research study is to learn more about serous endometrial cancer by creating three-dimensional (3-D) tissue models in the laboratory setting. The tissue models will provide scientists with a reliable, sensitive method to test biomarkers and cellular responses to treatment for endometrial cancer.
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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Rochester, MN
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
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Improving Adolescent And Young Adult Self-Reported Data In ECOG-ACRIN Trials
Rochester, MN
The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
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Efficacy Of [18F]PSMA-1007 PET/CT In Patients With Biochemial Recurrent Prostate Cancer
Rochester, MN
This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
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Vorinostat, Temozolomide, or Bevacizumab in Combination with Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients with Newly Diagnosed High-Grade Glioma
Rochester, MN
This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. ...
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Digital Stories And Psychosocial Wellbeing In Stem Cell Transplant Patients
Scottsdale/Phoenix, AZ
The proposed research will use a double-blind randomized controlled design to pilot test a model for how stories shared by a panel of HCT survivors impact the psychosocial well-being of the digital stories (DS) intervention condition of 55 patients who recently underwent HCT and their respective caregivers compared with 55 people in an information control (IC) condition and their caregivers (total 220 participants; N=110 per condition). Participants, recruited from the Mayo Clinic Arizona Cancer Center, will be randomly assigned to one of two conditions: the DS intervention or the IC video condition. Participants will questionnaires at baseline (T1), after the ...
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A Study To Evaluate The Effectiveness And Safety Of Camidanlumab Tesirine (ADCT-301) In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the clinical effectiveness and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
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Individualized Treatment In Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based On EBV DNA
Rochester, MN
There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses ...
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A Study In Subjects With Relapsed And Refractory Multiple Myeloma Receiving Carfilzomib In Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW)
Scottsdale/Phoenix, AZ
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
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Phase III Study To Assess AZD9833+ CDK4/6 Inhibitor In HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
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A Phase 1/2 Study Of CYT-0851 In B-Cell Malignancies And Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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Outcomes Of Low-risk Endometrial Cancer With Isolated Tumor Cells In The Sentinel Lymph Nodes: A Prospective Multicenter Single-arm Observational Study
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.
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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
Rochester, MN
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
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A Study To Evaluate Larotrectinib To Treat Patients With Previously Untreated TRK Fusion Solid Tumors And TRK Fusion Relapsed Acute Leukemia
Rochester, MN
The purpose of this study is to evaluate the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Patient Self-sampling Of HPV To Screen For Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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A Study To Evaluate Binimetinib In Combination With Encorafenib In Patients With Pancreatic Malignancies And A Somatic BRAFV600E Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.
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Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
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A Study to Analyze CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. It also aims to evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma and to evaluate the effectiveness of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
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A Study Of TAR-200 In Combination With Cetrelimab Or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) In Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (SunRISe-3)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
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Study Of ORIC-533 In Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
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A Study To Evaluate Immunotherapy And Ovarian Function Among Pre-menopausal Melanoma Survivors
Jacksonville, FL; Rochester, MN
The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.
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SX-682 Treatment In Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
Rochester, MN
The primary objective of this study is to determine the safety profile of SX-682 alone and in combination with pembrolizumab in subjects with metastatic melanoma, including the maximum dose that can be administered until adverse effects prevent further dose increases (i.e., the MTD or recommended phase 2 dose), and the dose-limiting toxicity (DLT).
The secondary objectives are to evaluate the efficacy of SX-682 in combination with pembrolizumab on the basis of the objective response rate, the duration of response, and the rate of progression, and to characterize the single-dose and multidose pharmacokinetic (PK) profile of SX-682.
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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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A Study To Evaluate Immunotherapy For Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.
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Brentuximab Vedotin And Nivolumab With Or Without Ipilimumab In Treating Patients With Relapsed Or Refractory Hodgkin Lymphoma
Rochester, MN
This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. Giving ipilimumab or nivolumab or both with ...
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A Study In Subjects With Relapsed And Refractory Multiple Myeloma Receiving Carfilzomib In Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW)
Scottsdale/Phoenix, AZ
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
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A Study To Evaluate The Effectiveness And Safety Of Camidanlumab Tesirine (ADCT-301) In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the clinical effectiveness and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
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Phase III Study To Assess AZD9833+ CDK4/6 Inhibitor In HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
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A Phase 1/2 Study Of CYT-0851 In B-Cell Malignancies And Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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Outcomes Of Low-risk Endometrial Cancer With Isolated Tumor Cells In The Sentinel Lymph Nodes: A Prospective Multicenter Single-arm Observational Study
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.
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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
Rochester, MN
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
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A Study To Evaluate Larotrectinib To Treat Patients With Previously Untreated TRK Fusion Solid Tumors And TRK Fusion Relapsed Acute Leukemia
Rochester, MN
The purpose of this study is to evaluate the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Patient Self-sampling Of HPV To Screen For Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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A Study To Evaluate Binimetinib In Combination With Encorafenib In Patients With Pancreatic Malignancies And A Somatic BRAFV600E Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.
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Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
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A Study To Evaluate Pemetrexed And Pembrolizumab To Treat Recurrent And/or Metastatic Salivary Gland Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate of the combination of Pemetrexed and Pembrolizumab in patients with recurrent or metastatic salivary gland cancer (R/M SGC).
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AZD5305 Vs Placebo In Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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A Study To Assess Dendritic Cell Immunotherapy Plus Standard-of-Care To Treat Advanced Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to evaluate CMN-001 in a randomized trial between standard-of-care (SOC) (first line ipilimumab+nivolumab followed by second line lenvatinib+everolimus) with or without CMN-001.
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Study Of Vorasidenib And Pembrolizumab Combination In Recurrent Or Progressive IDH-1 Mutant Glioma
Jacksonville, FL
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
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Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood In Patients With Relapsed And Resistant Ovarian Cancer
Scottsdale/Phoenix, AZ
The purpose of this study determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer.
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Phase 2 Trial Of Adagrasib Monotherapy And In Combination With Pembrolizumab And A Phase 3 Trial Of Adagrasib In Combination In Patients With A KRAS G12C Mutation KRYSTAL-7
Jacksonville, FL; Rochester, MN
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
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Phase 1 Study Of Oral TP-1454
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors as monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy, and to establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors.
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A Study To Evaluate DS-1062a Combined With Pembrolizumab In Advanced Or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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A Dose Escalation And Confirmation Study Of PT-112 In Advanced Solid Tumors In Combination With Avelumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as ...
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A Phase 2 Study Of Anti-PD-L1 Antibody Atezolizumab In Alveolar Soft Part Sarcoma
Rochester, MN
Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...
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A Study To Evaluate Pembrolizumab, Ixazomib Citrate, And Dexamethasone To Treat Participants With Relapsed Multiple Myeloma
Rochester, MN
This phase II trial studies how well pembrolizumab works when given together with ixazomib citrate and dexamethasone in treating participants with multiple myeloma that has come back. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together ...
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A Study To Evaluate PDS0101 And Pembrolizumab Combination To Treat Subjects With HPV16 + Recurrent And/or Metastatic Head And Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, And Nivolumab In Treating Patients With Stage I-II Hodgkin Lymphoma
Rochester, MN
This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...
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A Study To Evaluate Gemcitabine And MK-3475 (Pembrolizumab) To Treat Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...
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A Study To Evaluate Pembrolizumab For Surgically Treated Adjuvant Merkel Cell Carcinoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to determine how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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LEGEND Study: EG-70 In NMIBC Patients BCG-Unresponsive And High-Risk NMIBC Incompletely Treated With BCG Or BCG-Naïve
Scottsdale/Phoenix, AZ; Rochester, MN
This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC.
This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is.
The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
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Evaluating The Addition Of The Immunotherapy Drug Atezolizumab To Standard Chemotherapy Treatment For Advanced Or Metastatic Neuroendocrine Carcinomas That Originate Outside The Lung
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Rochester, MN
RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.
PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
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Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more cancer cells.
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I-SPY 2 TRIAL: Neoadjuvant And Personalized Adaptive Novel Agents To Treat Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Monitoring Symptoms To Help Young Women Take Hormone Therapy For Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; Eau Claire, WI; La Crosse, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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Saliva And Remote Monitoring Of Active Cytomegalovirus Infection And Symptoms During Ovarian Cancer Treatment
Rochester, MN
The purpose of this project is to determine the feasibility and accuracy of using saliva to remotely monitor CMV infection in individuals receiving treatment for ovarian cancer.
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A Study To Evaluate CB-839 With Radiation Therapy And Temozolomide In Treating Participants With IDH-Mutated Diffuse Astrocytoma Or Anaplastic Astrocytoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with ...
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A Study Of SAR442085 In Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B.
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Radiation Therapy With Or Without Chemotherapy In Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
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Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2
Rochester, MN
The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.
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A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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Randomized Phase II/III Trial Of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, Or Cisplatin-Atezolizumab In Pathologic High-Risk Squamous Cell Cancer Of The Head And Neck
Rochester, MN
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can ...
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A Study Of Ramucirumab (LY3009806) In Children And Young Adults With Synovial Sarcoma
Jacksonville, FL
The purpose of this study is to test the safety and effectives of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Jacksonville, FL
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
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A Study of Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia, or Refractory or Relapsed Acute Myelogenous Leukemia
Rochester, MN
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may stop this from happening.
PURPOSE: Natural Killer (NK) ...
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Semen Analysis In Chemotherapy
Rochester, MN
The purpose of this study is to correlate the impact of chemotherapy on semen analysis and the disease-free survival of patients undergoing gonadotoxic treatment for leukemia or lymphoma.
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A Study To Evaluate CB-839 HCl In Combination With Carfilzomib And Dexamethasone In Treating Patients With Recurrent Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work ...
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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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Specialty Compared To Oncology Delivered Palliative Care For Treating Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is to evaluate whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
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A Study to Analyze CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. It also aims to evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma and to evaluate the effectiveness of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma.
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A Study Of TAR-200 In Combination With Cetrelimab Or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) In Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (SunRISe-3)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
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Study Of ORIC-533 In Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
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SX-682 Treatment In Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
Rochester, MN
The primary objective of this study is to determine the safety profile of SX-682 alone and in combination with pembrolizumab in subjects with metastatic melanoma, including the maximum dose that can be administered until adverse effects prevent further dose increases (i.e., the MTD or recommended phase 2 dose), and the dose-limiting toxicity (DLT).
The secondary objectives are to evaluate the efficacy of SX-682 in combination with pembrolizumab on the basis of the objective response rate, the duration of response, and the rate of progression, and to characterize the single-dose and multidose pharmacokinetic (PK) profile of SX-682.
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A Study To Evaluate Immunotherapy And Ovarian Function Among Pre-menopausal Melanoma Survivors
Jacksonville, FL; Rochester, MN
The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.
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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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A Study To Evaluate Immunotherapy For Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.
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Brentuximab Vedotin And Nivolumab With Or Without Ipilimumab In Treating Patients With Relapsed Or Refractory Hodgkin Lymphoma
Rochester, MN
This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. Giving ipilimumab or nivolumab or both with ...
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A Study To Better Understand How To Predict And Manage Patients Who Are At High Risk For Developing Rheumatic Immune-related Adverse Events While Receiving Treatment For Melanoma
Rochester, MN
The purpose of this study is to:
- Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
- Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
- Establish a repository of biological samples from patients with irAE and corresponding rheumatologic
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A Study To Evaluate TG4050 In Ovarian Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability, as well as some activity parameters, of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.
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A Study To Evaluate Chemotherapy-Induced Nausea In Breast Cancer Patients
Albert Lea, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Mankato, MN; Rochester, MN
The long-term goal of this study is to alleviate the occurrence of CIN and fatigue and to improve chemotherapy treatment outcomes. The identification of associations between fatigue, CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie patient symptom experience. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate fatigue and CIN.
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Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy In HER2-positive Breast Cancer Patients
Rochester, MN
The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.
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The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Jacksonville, FL; Rochester, MN
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
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Niraparib + TSR042 In BRCA Mutated Breast Cancer
Rochester, MN
The purpose of this study is to evaluate pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA mutations. The drugs are Niraparib (Zejula) and Dostarlimab.
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A Study Assessing The Effectiveness And Safety Of Alpelisib + Nab-paclitaxel In Subjects With Advanced Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)
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A Study To Evaluate Estrogen Receptor (ER) Reactivation Therapy For Breast Cancer
Rochester, MN
The purpose of this study is to evaluate whether or not treatment with alternating 17B-estradiol / anti-estrogen therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth than continuous treatment with either type of therapy in patients with metastatic anti-estrogen-resistant ER+ breast cancer.
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Saliva And Remote Monitoring Of Active Cytomegalovirus Infection And Symptoms During Ovarian Cancer Treatment
Rochester, MN
The purpose of this project is to determine the feasibility and accuracy of using saliva to remotely monitor CMV infection in individuals receiving treatment for ovarian cancer.
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A Study To Evaluate CB-839 With Radiation Therapy And Temozolomide In Treating Participants With IDH-Mutated Diffuse Astrocytoma Or Anaplastic Astrocytoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with ...
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A Study Of SAR442085 In Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B.
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Radiation Therapy With Or Without Chemotherapy In Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
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Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2
Rochester, MN
The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.
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A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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Randomized Phase II/III Trial Of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, Or Cisplatin-Atezolizumab In Pathologic High-Risk Squamous Cell Cancer Of The Head And Neck
Rochester, MN
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can ...
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A Study Of Ramucirumab (LY3009806) In Children And Young Adults With Synovial Sarcoma
Jacksonville, FL
The purpose of this study is to test the safety and effectives of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
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A Study of Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia, or Refractory or Relapsed Acute Myelogenous Leukemia
Rochester, MN
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may stop this from happening.
PURPOSE: Natural Killer (NK) ...
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Jacksonville, FL
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
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Semen Analysis In Chemotherapy
Rochester, MN
The purpose of this study is to correlate the impact of chemotherapy on semen analysis and the disease-free survival of patients undergoing gonadotoxic treatment for leukemia or lymphoma.
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A Study To Evaluate CB-839 HCl In Combination With Carfilzomib And Dexamethasone In Treating Patients With Recurrent Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work ...
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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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Specialty Compared To Oncology Delivered Palliative Care For Treating Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is to evaluate whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
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A Study Of Three-dimensional (3-D) Tissue Models In Patients With Serous Endometrial Cancer Planning To Undergo Surgery
Jacksonville, FL; Rochester, MN
The purpose of this research study is to learn more about serous endometrial cancer by creating three-dimensional (3-D) tissue models in the laboratory setting. The tissue models will provide scientists with a reliable, sensitive method to test biomarkers and cellular responses to treatment for endometrial cancer.
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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Rochester, MN
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
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Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
No Locations
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill ...
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Assessing Breast Cancer Risk Perception In Hispanic, Black, And Black Hispanic Women
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to understand how women of color from diverse racial and ethnic backgrounds conceptualize their current and lifetime risk for breast cancer (BC) and to identify which risk factors most resonate with perceptions of BC risk.
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Study Of AZD0466 Monotherapy Or In Combination In Patients With Advanced Haematological Malignancies
Jacksonville, FL
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and effectiveness of AZD0466 as monotherapy in participants with advanced haematological malignancies, and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.
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Spinal Cord Stimulation To Treat Chemotherapy-Induced Peripheral Neuropathy
Rochester, MN
The purpose of this study is to understand pain outcomes in patients with cancer who have Chemotherapy-Induced Peripheral Neuropathy (CIPN).
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A Study To Determine Recommended Dose, Regimen And Evaluate The Safety And Preliminary Effectiveness Of CC-92480 In Combination With Standard Treatments In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM) And Newly Diagnosed Multiple Myeloma (NDMM)
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary effectiveness of CC-92480 in combination with standard treatments.
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First In Human Study Of TORL-1-23 In Participants With Advanced Cancer
Rochester, MN
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
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JAB-21822 Activity In Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives of this study are to evaluate the overall safety and tolerability of JAB-21822 monotherapy, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) of JAB-21822 and in combination with cetuximab administered by prescription (QD) in participants with relapsed or refractory solid tumors with KRAS G12C mutation.
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A Study Of Bendamustine And Rituximab Alone Versus In Combination With Acalabrutinib In Subjects With Previously Untreated Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
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S1304, Carfilzomib And Dexamethasone For Treating Patients With Relapsed Or Refractory Myeloma
Jacksonville, FL; Rochester, MN
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer ...
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A Dose Escalation Study Of HFB301001 In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).
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E6201 Plus Dabrafenib For The Treatment Of Metastatic Melanoma Central Nervous System Metastases (CNS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.
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A Study of the Use of Molecular Breast Imaging to Evaluate Breast Cancer Tumor Response to Therapy that is Newly Supplemental to Standard Treatment
Rochester, MN
The purpose of this study is to evaluate the use of molecular breast imaging as an accurate way to assess the response of breast cancer tumors to chemotherapy or hormone therapy that is newly supplemental to the standard treatment.
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Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms
Rochester, MN
The purpose of this study is to analyze the impact of active participation of patients in producing tones in combination with breathing technique; i.e., TBT to reduce aromatase inhibitor induced musculoskeletal symptoms.
Tonation Breathing Techniques (TBT) is a set of diverse, mostly non-strenuous, specialized breathing techniques with the addition of Tonation; i.e., controlled exhalation through nostrils or lips while producing and sustaining a constant sound frequency as is comfortable to the participant as instructed in Musopathy sessions and/or videos.
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Combination Study Of SV-BR-1-GM In Combination With INCMGA00012 And Retifanlimab
Jacksonville, FL
The purpose of this study is to evaluate SV-BR-1-GM in metastatic or locally recurrent breast cancer patients, in combination with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat. Patients who with advanced breast cancer who have failed prior therapies will be eligible to enroll in this study. The study will evaluate SV-BR-1-GM in combination with INCMGA00012 and epacadostat. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 6-12 weeks.
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Taletrectinib Phase 2 Global Study In ROS1 Positive NSCLC
Rochester, MN
The main purpose of the study is to evaluate safety and effectiveness of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
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Comparing The Investigational Imaging System With Sonography
Rochester, MN
The short-term goal of the proposed research is to develop a new method for viscoelasticity imaging of breast that can work with any type of wave, and not restricted to plane shear waves.
The long-term goal of this project is to develop an ultrasound-based breast imaging technique to improve the diagnostic specificity in breast cancer.
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A Clinical Study Of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) In People With Breast Cancer (MK-2870-032)
Scottsdale/Phoenix, AZ; Jacksonville, FL
Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab ...
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Pemigatinib To Treat Metastatic Or Unresectable Colorectal Cancer Harboring FGFR Alterations
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
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TheraSphere With And Without Durvalumab And Tremelimumab For HCC
Jacksonville, FL
The objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.
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A Study To Learn About The Study Medicine (Elranatamab) In Participants With Multiple Myeloma That Has Come Back After Responding To Treatment Or Has Not Responded To Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and effectiveness of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every ...
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Extracellular Impact Of Ultrasound-induced Blood-brain Barrier Disruption
Rochester, MN
The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.
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Investigation Of Ubamatamab Combination Therapy In Adult Participants With Platinum-Resistant Ovarian Cancer
Jacksonville, FL
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug ...
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Hypofractionated Radiotherapy With Folfox For Esophageal/Gej Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate non-inferiority of pCR with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.
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Ibrutinib In Treating Minimal Residual Disease In Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy
Jacksonville, FL
This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Ibrutinib In Treating Patients With Relapsed Hairy Cell Leukemia
Rochester, MN
This phase II trial studies how well ibrutinib works in treating patients with relapsed hairy cell leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody In Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of ZB131 in patients with solid tumors where prevalence of CSP expression is high.
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MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)
Rochester, MN
This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.
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A Trial To Evaluate The Safety Of GEN1046 In Patients With Malignant Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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A Study To Determine Recommended Dose, Regimen And Evaluate The Safety And Preliminary Effectiveness Of CC-92480 In Combination With Standard Treatments In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM) And Newly Diagnosed Multiple Myeloma (NDMM)
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary effectiveness of CC-92480 in combination with standard treatments.
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Study Of AZD0466 Monotherapy Or In Combination In Patients With Advanced Haematological Malignancies
Jacksonville, FL
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and effectiveness of AZD0466 as monotherapy in participants with advanced haematological malignancies, and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.
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Spinal Cord Stimulation To Treat Chemotherapy-Induced Peripheral Neuropathy
Rochester, MN
The purpose of this study is to understand pain outcomes in patients with cancer who have Chemotherapy-Induced Peripheral Neuropathy (CIPN).
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First In Human Study Of TORL-1-23 In Participants With Advanced Cancer
Rochester, MN
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
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JAB-21822 Activity In Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives of this study are to evaluate the overall safety and tolerability of JAB-21822 monotherapy, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) of JAB-21822 and in combination with cetuximab administered by prescription (QD) in participants with relapsed or refractory solid tumors with KRAS G12C mutation.
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A Dose Escalation Study Of HFB301001 In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).
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E6201 Plus Dabrafenib For The Treatment Of Metastatic Melanoma Central Nervous System Metastases (CNS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.
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A Study Of Bendamustine And Rituximab Alone Versus In Combination With Acalabrutinib In Subjects With Previously Untreated Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
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S1304, Carfilzomib And Dexamethasone For Treating Patients With Relapsed Or Refractory Myeloma
Jacksonville, FL; Rochester, MN
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer ...
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Ease Aromatase Inhibitor-induced Musculoskeletal Symptoms
Rochester, MN
The purpose of this study is to analyze the impact of active participation of patients in producing tones in combination with breathing technique; i.e., TBT to reduce aromatase inhibitor induced musculoskeletal symptoms.
Tonation Breathing Techniques (TBT) is a set of diverse, mostly non-strenuous, specialized breathing techniques with the addition of Tonation; i.e., controlled exhalation through nostrils or lips while producing and sustaining a constant sound frequency as is comfortable to the participant as instructed in Musopathy sessions and/or videos.
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Combination Study Of SV-BR-1-GM In Combination With INCMGA00012 And Retifanlimab
Jacksonville, FL
The purpose of this study is to evaluate SV-BR-1-GM in metastatic or locally recurrent breast cancer patients, in combination with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat. Patients who with advanced breast cancer who have failed prior therapies will be eligible to enroll in this study. The study will evaluate SV-BR-1-GM in combination with INCMGA00012 and epacadostat. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 6-12 weeks.
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A Study of the Use of Molecular Breast Imaging to Evaluate Breast Cancer Tumor Response to Therapy that is Newly Supplemental to Standard Treatment
Rochester, MN
The purpose of this study is to evaluate the use of molecular breast imaging as an accurate way to assess the response of breast cancer tumors to chemotherapy or hormone therapy that is newly supplemental to the standard treatment.
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A Study To Evaluate The Efficacy Of A Hybrid Imaging And Measurement Tool For Breast Cancer Detection And Monitoring
Rochester, MN
The purpose of this research is to optimize and evaluate the efficacy of a hybrid imaging and quantitative viscoelasticity measurement tool for breast cancer detection and monitoring.
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A Study To Evaluate The Surgical Removal Of Residual Brain Tumors Prior To Recurrence
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors. Eligible patients with surgically accessible latent tumors desiring surgical resection will be enrolled to prospectively track short- and long-term outcomes. Safety will be evaluated by quantifying rates of surgical morbidity as compared to patients undergoing RT after surgery, or no surgery for similar latent disease. Variables evaluated will include postoperative complications including death within 30 days, wound infection, length of hospital stay, and readmission rates.
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Abemaciclib Versus Placebo In Patients With Advanced Dedifferentiated Liposarcoma
Jacksonville, FL
The purpose of this study is to evaluate abemaciclib versus placebo to treat Advanced Dedifferentiated Liposarcoma. Patients with progression of disease will cross over to open label abemaciclib.
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Nanopore Sequencing For Detecting Bacteria In Bile And Preventing Surgical Site Infections In Patients Undergoing Surgery For Benign Or Malignant Pancreatic Tumors
Rochester, MN
The objectives of this study are to reduce the rate of bacterobilia driven surgical site infection (SSI) in patients undergoing pancreatic head resection by providing surgical team with NS data in the post-operative setting, and to reduce cost of care through reduction in SSI and improved antibiotic stewardship.
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A Study Of HFB200301 In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
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A Dose Escalation Study Of Amivantamab In Participants With Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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A Study To Determine The Best Individualized Cancer Therapy Using Circulating Tumor DNA (CtDNA) In Patients With GI, CNS, And Thoracic Cancers.
Jacksonville, FL
This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.
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Reduced Craniospinal Radiation Therapy And Chemotherapy In Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma
Rochester, MN
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as ...
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A Study Of TNB-383B In Subjects With Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNB-383B, a T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks (Q3W), in approximately 24 subjects. Once the maximum tolerated dose (MTD) or ...
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Focused Radiation Versus Systemic Therapy For Kidney Cancer Patients With Limited Metastasis, SOAR Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to compare the effect of stero-ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with kidney cancer that has spread from where it first started (primary site) to a limited (2-5) number of places in the body (metastatic).
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Impact Of Neoadjuvant Chemotherapy On The Peripheral Blood Immune Phenotype In Operable Breast Cancer, The ENHANCE Study
Rochester, MN
The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
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Pertuzumab And Trastuzumab As Neoadjuvant Treatment In Patients With HER2-Positive Breast Cancer
Rochester, MN
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
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School Employees Breast Cancer Risk Due To Environmental Exposures
Rochester, MN
The purpose of this study is to conduct exploratory comparisons of 1) the environmental exposures of the cases and controls through numerous methodologies including metal analysis, metabolomics, and exposomics. Samples collected will include hair, nails, blood, and urine.
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Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
Rochester, MN
This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan
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Breast Cancer: Can We Predict Pathological Complete Response Following Neoadjuvant Treatment?
Scottsdale/Phoenix, AZ
This project will investigate whether ctDNA analysis in newly diagnosed stage I, II, III breast cancer patients treated with neoadjuvant systemic therapy can predict pathological Complete Response (pCR).
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A Study to Evaluate MRI-guided Cryoablation for Focal Native Intermediate Grade Prostate Cancer
Rochester, MN
The purpose of this study is to investigate MR-guided cryoablation of biopsy proven Gleason 7 prostate cancers using the Galil MR-compatible cryoablation system to monitor the technqiue and prospectively collect the data. The system is already FDA (510k) approved for soft tissue ablation and has been utilized successfully at Mayo previously.
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Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.
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A Study Of T-VEC And Radiation To Treat Localized Soft Tissue Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects of talimogene laherparepvec and radiation therapy to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.
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Acceptance And Commitment Therapy For Cancer Distress Among Rural And Urban Patients With Hepatobiliary Cancers
Rochester, MN
The purpose of this study is to assess standardized benchmarks of intervention feasibility and acceptability for remotely delivered, group ACT-HBC, as tested with a single-arm pilot study. Determine if there are changes in psychological variables from baseline to completion of the ACT-HBC intervention. To explore the preliminary impact of rural status on feasibility and acceptability of the intervention in addition to outcomes of distress and theory-based statistical mediators/psychological mechanisms of ACT-HBC.
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CTX131 In Relapsed/Refractory Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamic effects of CTX131 in adult study subjects with relapsed or refractory (r/r) hematologic malignancies.
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Fasting Mimicking Diet For Reducing Immune Related Adverse Events For Cancer Patients On Immune Checkpoint Inhibitors, FMD-ICI Trial
Jacksonville, FL
The FMD-ICI study will utilize animal and human data that finds that fasting may promote survival mechanisms and stress resiliency. The study aims to assess the impact that a restrictive calorie diet, mostly of fat and complex carbohydrates, mimicking fasting and increasing resiliency will have in protecting patients from the adverse effects of all advanced cancer treatments which require immunotherapy. By managing the adverse side effects of ICI treatments in select cancer patients, the study will assess the effect of immunotherapy plus the Xentigen fasting mimicking diet on adverse events rates, including immune-mediated colitis. Patients will be supplied with all their dietary requirements for 4 ...
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A Study to Establish a Living Breast Organoid Biobank for Translational Research
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers at Mayo Clinic are developing a Biobank of adult stem cell-rich breast organoids, a new research resource to facilitate normal and cancer stem cell research. Subjects in the Biobank will provide samples of excess breast tissue, complete a health questionnaire, and allow access to medical records now and in the future. The Biobank serves as a library for researchers; instead of having to look for volunteers for each new project, researchers can use samples from the Biobank as well as share information already collected.
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Molecular Breast Imaging in Women with Atypia and LCIS
Rochester, MN
We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.
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Kinetics Of Troponin And BNP In Breast Cancer Chemotherapy With Adriamycin And Trastuzumab
Jacksonville, FL
This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have ...
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Optical Fusion Trans-Perineal Grid
Rochester, MN
The purpose of this study is to evaluate and assess a new perineal access tool to enable image guided prostate interventions by Clear Guide Medical in collaboration with the Mayo Clinic.
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CfDNA With Natera
Rochester, MN
The purpose of this study is to collect blood and tumor tissue from esophageal cancer patients in order to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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Acceptance And Commitment Therapy Compassion-Based Virtual Group Intervention For Diverse Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the impact of an Acceptance and Commitment Therapy and Compassion-Based virtual group intervention for diverse cancer patients at Mayo Clinic in Arizona.
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Improving Treatment Planning Suing LiDAR Surface Mapping Of Radiotherapy Patients
Jacksonville, FL
The purpose of this study is to show the feasibility of using the LiDAR scanner to supplement the radiation treatment simulation CT scan.
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Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
No Locations
Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
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Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients with Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells.
PURPOSE: This phase I trial studies the side effects and ...
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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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Phase II Venetoclax, Obinutuzumab And Bendamustine In High Tumor Burden Follicular Lymphoma As Front Line Therapy
Rochester, MN
Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma.
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A Study To Compare ACP-196 And Obinutuzumab With Chlorambucil, Or ACP-19 Alone, With Obinutuzumab And Chlorambucil, For Patients With Previously Untreated Chronic Lymphocytic Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of ACP-196 combined with obinutuzumab, or ACP-196 alone compared with obinutuzumab combined with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL).
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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) In Patients With Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).
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A Study To Evaluate Triapine Combined With Lutetium Lu 177 Dotatate For Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor at 3 years.
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A Study To Evaluate Androgen-Deprivation Therapy And Radiation Therapy In Treating Patients With Prostate Cancer
La Crosse, WI
The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area in patients with prostate cancer to find out which is better.
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Pembrolizumab, Dabrafenib, And Trametinib Before Surgery For The Treatment Of BRAF-Mutated Anaplastic Thyroid Cancer
Rochester, MN
This phase II trial studies the effect of pembrolizumab, dabrafenib, and trametinib before surgery in treating patients with BRAF V600E-mutated anaplastic thyroid cancer. BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. It may increase the growth and spread of tumor cells. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Durvalumab And Grid Therapy For The Treatment Of Non-small Cell Lung Cancer In Patients Who Progressed During Or After Treatment With The PACIFIC Regimen
Rochester, MN
The purpose of this study is to determine whether combining grid therapy at the time of disease progression during durvalumab administration or shortly after durvalumab discontinuation may permit patients to continue on durvalumab which was otherwise effective at preventing polymetastatic disease.
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Safety And Efficacy Of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells In Subjects With Relapsed Or Refractory BAFFR-expressing B-cell Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of escalating doses of MC10029 following lymphodepleting (LD) therapy in subjects with relapsed or refractory BAFFR-expressing B-cell hematologic malignancies to determine the recommended dose for phase 1b (dose expansion).
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Atezolizumab, Pemetrexed Disodium, Cisplatin, And Surgery With Or Without Radiation Therapy In Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Scottsdale/Phoenix, AZ; Rochester, MN
To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe (as defined in Section 11.1) for patients with resectable malignant pleural mesothelioma.
a. To evaluate progression free survival (both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.
b. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.
c. ...
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Testing The Addition Of The Drug Atezolizumab To The Usual Radiation Treatment For Patients With Early Non-small Cell Lung Cancer
La Crosse, WI
This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy ...
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Isotretinoin With or Without Monoclonal Antibody Ch14.18, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
Rochester, MN
This partially randomized phase III trial studies isotretinoin with monoclonal antibody Ch14.18, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to ...
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A Study Of Ibrutinib With Rituximab In People With Untreated Marginal Zone Lymphoma
Rochester, MN
The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.
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Evaluation of Sensibility with Targeted Nipple Areola Complex Re-innervation in Nipple Sparing Mastectomy
Scottsdale/Phoenix, AZ
To determine the effectiveness of targeted nipple areola complex (NAC) re-innervation for improving sensibility in women undergoing nipple sparing mastectomy (NSM).
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Long Term Follow-Up Of Subjects Exposed To GSK3377794
Jacksonville, FL; Rochester, MN
The purpose of this long-term, followup study is to evaluate subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
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A Pilot, Randomized, Open-label Study Of Tumor Treating Fields (TTFields, 150 KHz) Concomitant With Pembrolizumab For First Line Treatment Of Advanced Or Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the objective response rate (ORR) by RECIST 1.1 in subjects with TPS ≥ 1 percent.
The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Atezolizumab In Combination With A Multi-Kinase Inhibitor For The Treatment Of Unresectable, Locally Advanced, Or Metastatic Liver Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to test whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...
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Retifanlimab And Epacadostat In Combination With Radiation And Bevacizumab In Patients With Recurrent Gliomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.
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Trial Using Keytruda As Initial Therapy In The Treatment Of Advanced Mycosis Fungoides
Jacksonville, FL
The purpose of this trial is to evaluate the antitumor activity of Pembrolizumab in patients with advanced mycosis fungoides (MF) as initial systemic therapy.
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A Study To Evaluate AFPᶜ³³²T In Advanced HCC
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer.
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Pembrolizumab Alone Or With Idelalisib Or Ibrutinib In Treating Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Other Low-Grade B-Cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas that have returned after a period of improvement or have not responded to treatment. Monoclonal antibodies can block cancer growth in different ways. Pembrolizumab may block cancer growth by blocking a cell that protects the cancer from the immune system and allowing the immune system to attack the cancer. Idelalisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab alone ...
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Study Of TJ011133 In Participants With Relapsed/ Refractory Advanced Solid Tumors And Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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A Study To Evaluate Regional Radiotherapy In Biomarker Low-Risk Node Positive Breast Cancer
Jacksonville, FL
The purpose of this study is to compare the effects on low-risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
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A Study Of Tucatinib Or Placebo With Trastuzumab And Pertuzumab For Metastatic HER2+ Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body ...
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Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors
Jacksonville, FL
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
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Ultrasound-guided Tissue Acquisition Of Hepatic Draining Lymph Nodes In The Evaluation Of Unresectable Perihilar Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to test the feasibility of NanoString digital spatial profiling (DSP) and RNAscope™ on prospectively acquired HDLN tissue samples with EUS-FNB in patients with unresectable perihilar CCA undergoing liver transplant (LT) evaluation.
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A Study To Evaluate Wound Infiltration With Liposomal Bupivacaine In Laparotomy For Gynecological Malignancy
Rochester, MN
The purpose of this study is to determine whether or not there is a benefit to adding opioid injection around the spinal cord ( intrathecal) to incisional long-acting local anesthetic (liposomal bupivacaine) injection for pain management after abdominal surgery for gynecological cancer.
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Amino Acid Pet For Brain Tumors
Rochester, MN
The purpose of this study is to utilize amino acid PET such as 18F-DOPA PET/CT for use in brain tumor patients.
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Remote Intervention For Strength Training In Endometrial Cancer
Rochester, MN
The purpose of this study is to positively impact endometrial cancer (EC) survivorship through a fully remote home-based exercise program. We believe this type of survivorship care will be accessible, sustainable, and scalable. We seek to design and implement a telehealth strength-based exercise intervention in rural EC survivors, a group currently overlooked in most survivorship studies.
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A Comparison Of TULSA Procedure Vs. Radical Prostatectomy In Participants With Localized Prostate Cancer (CAPTAIN)
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare the safety and effectiveness for the TULSA Procedure versus radical prostatectomy in treating men with localized intermediate-risk prostate cancer.
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Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Jacksonville, FL; Rochester, MN
This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others ...
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A Study To Assess Multiparametric MR Elastography (MRE) In Diagnosing And Monitoring Cirrhosis Or Hepatocellular Carcinoma (HCC) Patients
Rochester, MN
The primary purpose of this study is to is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for early identification of hepatocellular carcinoma (HCC) involvement, differentiation, and risks of microvascular invasion.
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A Study To Evaluate Encorafenib Plus Cetuximab With/without Chemotherapy To Treat Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
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Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
Rochester, MN
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. ...
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survey with parents of children who had proton treatment for brain tumors
Rochester, MN
The overall goal of this project is to survey parents of children who have undergone proton radiation for brain tumors and collect key information that will improve the feasibility of our proposed intervention. The survey will include questions on experience with proton treatment and opinion regarding a proposed early intervention.
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A Study Of Prehabilitation In Patients With Multiple Myeloma Receiving CAR-T Therapy
Rochester, MN
The purpose of this study is to evaluate the feasibility and acceptability of a 6-week home-based virtual prehabilitation program with remote monitoring in 20 patients ≥60 years with relapsed/refractory (R/R) multiple myeloma (MM) scheduled to receive CAR-T therapy at Mayo Clinic – Rochester.
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A Study Of Adjuvant Cretostimogene Grenadenorepvec For Treatment Of Intermediate Risk NMIBC Following TURBT
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
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A Study To Evaluate Tazemetostat Combined With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of tazemetostat in combination with R2 in subjects with Relapsed/Refractory Follicular Lymphoma (R/R FL), who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
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A Study to Optimize Patient Selection and Outcomes in Laryngeal Vascular Composite Allograft Transplantation
Scottsdale/Phoenix, AZ
In-depth qualitative interviews will be performed to explore beliefs of laryngotracheal transplant candidates, their caregivers, and clinicians about their perceptions and experience of the laryngotracheal transplantation process. In addition, we will explore the quality of life of patients with a laryngectomy.
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Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Rochester, MN
Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.
Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.
GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity ...
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination ...
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A Phase II, Multicenter Study Of The EZH2 Inhibitor Tazemetostat In Adult Subjects With INI1-Negative Tumors Or Relapsed/Refractory Synovial Sarcoma
Jacksonville, FL
This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID administered orally in continuous 28 day cycles. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor type: - Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO] - Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX ...
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A Study Of DKN-01 In Combination With Tislelizumab ± Chemotherapy In Patients With Gastric Or Gastroesophageal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of DKN-01 in combination with tislelizumab ± CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.
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Study Of Targeted Therapy Vs. Chemotherapy In Patients With Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.
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Niraparib In Combination With Trastuzumab In Metastatic HER2+ Breast Cancer
Rochester, MN
The purpose of this study is to evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer.
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Tumor Treating Fields For The Treatment Of Leptomeningeal Metastases Of The Spine In Patients With Breast Or Lung Cancer
Jacksonville, FL
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
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A Study Of DKN-01 In Combination With Tislelizumab ± Chemotherapy In Patients With Gastric Or Gastroesophageal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of DKN-01 in combination with tislelizumab ± CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.
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Study Of Targeted Therapy Vs. Chemotherapy In Patients With Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.
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Tumor Treating Fields For The Treatment Of Leptomeningeal Metastases Of The Spine In Patients With Breast Or Lung Cancer
Jacksonville, FL
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
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Niraparib In Combination With Trastuzumab In Metastatic HER2+ Breast Cancer
Rochester, MN
The purpose of this study is to evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer.
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Surgical Drain Fluid For Detection Of Molecular Residual Disease For HPV(-) Head And Neck Cancers
Rochester, MN
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with HPV(-) head and neck cancer.
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A Study To Evaluate Tazemetostat And Pembrolizumab To Treat Advanced Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to conduct a safety lead-in phase that identifies the safe recommended phase II dose for combination tazemetostat and MK-3475 (pembrolizumab) in patients with advanced urothelial carcinoma.
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Lenalidomide And Dexamethasone With Or Without Bortezomib In Treating Patients With Previously Untreated Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell ...
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A Study To Evaluate The Safety And Efficacy Of Mesothelin-Targeting Logic-gated CAR T, In Participants With Solid Tumors That Express MSLN And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment ...
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An Open-label Study Using ASP-1929 Photoimmunotherapy In Combination With Anti-PD1 Therapy In EGFR Expressing Advanced Solid Tumors
Rochester, MN
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.
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Obtain Fresh Glioblastoma Tissue To Analyze Cell Count And Viability In Developing IGV-001
Jacksonville, FL
The purpose of this study is to utilize fresh tumor tissue to aid the development of future therapies for brain cancer.
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Photoradiation With Verteporfin To Facilitate Immunologic Activity Of Pembrolizumab In Unresectable, Locally Advance Or Metastatic Pancreatic Cancer
Rochester, MN
We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.
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A Study To Evaluate Treatment Of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Rochester, MN
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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FT516 In Subjects With Advanced Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate appropriate dosage of FT516 as monotherapy in acute myeloid leukemia (AML), and in combination with CD20 directed monoclonal antibodies, in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
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Daratumumab Retreatment In Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)
Rochester, MN
The purpose of this study is to compare the effectiveness (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
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A Trial To Evaluate Multiple Regimens In Newly Diagnosed And Recurrent Glioblastoma
Jacksonville, FL; Rochester, MN
The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
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TRPC6 To Predict And Prevent Chemotherapy Related Cardiomyopathy And Heart Failure (Prospective Study)
Jacksonville, FL
The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.
Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years)
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Study Of The Bria-IMT Regimen And CPI Vs Physicians' Choice In Advanced Metastatic Breast Cancer. (BRIA-ABC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
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A Phase I/II, Open-label, Multi-center Trial Of [177Lu]Lu-NeoB In Combination With Capecitabine In Adult Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression On Previous Endocrine Therapy In Combination With A CDK4/6 Inhibito
Rochester, MN
The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).
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A Study To Evaluate The Safety Of Lasofoxifene In Combination With Abemaciclib In Advanced Or Metastatic ER+/HER2− Breast Cancer With ESR1 Mutation
Jacksonville, FL; Rochester, MN
The purpse of this study is to evaluate the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
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Pilot Clinical Study To Evaluate Molecular Breast Imaging- Guidance For Sampling Of Breast Abnormalities In Patients With Known Or Suspected Breast Cancer
Rochester, MN
The purpose of this study is to confirm that the Stereo Navigator accessory to an MBI Imging system can successfully guide the sampling of abnormal MBI findings in patients with known or suspected breast cancer.
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Optical Fusion Trans-Perineal Grid
Rochester, MN
The purpose of this study is to evaluate and assess a new perineal access tool to enable image guided prostate interventions by Clear Guide Medical in collaboration with the Mayo Clinic.
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Acceptance And Commitment Therapy Compassion-Based Virtual Group Intervention For Diverse Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the impact of an Acceptance and Commitment Therapy and Compassion-Based virtual group intervention for diverse cancer patients at Mayo Clinic in Arizona.
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Improving Treatment Planning Suing LiDAR Surface Mapping Of Radiotherapy Patients
Jacksonville, FL
The purpose of this study is to show the feasibility of using the LiDAR scanner to supplement the radiation treatment simulation CT scan.
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CfDNA With Natera
Rochester, MN
The purpose of this study is to collect blood and tumor tissue from esophageal cancer patients in order to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
No Locations
Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
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Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients with Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells.
PURPOSE: This phase I trial studies the side effects and ...
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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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Phase II Venetoclax, Obinutuzumab And Bendamustine In High Tumor Burden Follicular Lymphoma As Front Line Therapy
Rochester, MN
Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma.
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A Study To Compare ACP-196 And Obinutuzumab With Chlorambucil, Or ACP-19 Alone, With Obinutuzumab And Chlorambucil, For Patients With Previously Untreated Chronic Lymphocytic Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of ACP-196 combined with obinutuzumab, or ACP-196 alone compared with obinutuzumab combined with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL).
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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) In Patients With Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).
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A Study To Evaluate Triapine Combined With Lutetium Lu 177 Dotatate For Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor at 3 years.
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Radiation Therapy With Or Without Androgen-Deprivation Therapy In Treating Patients With Prostate Cancer
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
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A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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Endoscopic Radiofrequency Ablation Induced Tumor Microenvironment Remodeling In Cholangiocarcinoma
Rochester, MN
The objective of the study is to study the systemic immunological effects of Radiofrequency Ablation in patients with advanced Extrahepatic cholangiocarcinoma.
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A Study To Compare Nivolumab Or Brentuximab Vedotin Plus Combination Chemotherapy To Treat Patients With Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...
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A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).
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Inotuzumab Ozogamicin And Post-Induction Chemotherapy In Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, And B-LLy
Rochester, MN
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...
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Pembrolizumab And Ibrutinib In Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery
Rochester, MN
This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.
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A Study Evaluating The Effectiveness Of Axicabtagene Ciloleucel Compared To Standard Of Care Therapy In Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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A Randomized Trial Of Pembrolizumab & Radiotherapy Versus Radiotherapy In High-Risk Soft Tissue Sarcoma Of The Extremity
Jacksonville, FL
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
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Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)
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Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol To Reduce Incidence Of Heart Failure
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.
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A Study to Compare Intravesical Therapy and Surgery to Treat Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery ...
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Comparing The Addition Of Radiation Either Before Or After Surgery For Patients With Brain Metastases
Jacksonville, FL
The purpose of this study is to compare the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases).
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ROF2181
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Currently, only a few international institutions use CIRT to treat pelvic bone sarcomas. Accordingly, data evaluating the potential differences in oncological outcomes, toxicities, and functional outcomes between CIRT and the more readily accessible local therapies of surgery and PT is scarce. For this reason, we propose conducting a prospective comparative effectiveness study evaluating functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.
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Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
No Locations
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: ...
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Tazemetostat In Combination With Doxorubicin As Frontline Therapy For Advanced Epithelioid Sarcoma
Jacksonville, FL
The purpose of this study is to establish a recommended phase 3 dose (RP3D) and to evaluate the efficacy, PK, and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in subjects with advanced epithelioid sarcoma (ES). This study will be conducted in 2 parts.
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A Study Of ASTX660 Alone Or Combined With ASTX727 In Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
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The Captivator EMR Registry
Jacksonville, FL; Rochester, MN
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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Improving Management Of Breast Biopsy With Genetic Testing
Jacksonville, FL
The purpose of this study is to collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) and related single-nucleotide polymorphisms (SNPs) to final diagnosis of DCIS, invasive breast cancer or BBD; BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise. Also, to relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries. Additionally, to relate PRS (and related SNPs) to molecular markers in pathologic lesions and background ...
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ZTE MRI For Visualization Of Bone Cement, Breast Biopsy Markers
Rochester, MN
The purpose of this study is to demonstrate that ZTE allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.
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A Study To Evaluate The Safety Of HANAROSTENT® Biliary Flap Lasso Stent System Use To Treat Cancer Patients With Biliary Obstruction
Rochester, MN
The purpose of this study is to demonstrate clinical performance and safety of the fully covered (FC) HANAROSTENT® Biliary Flap Lasso Stent System with anti-migration flaps for the palliative treatment of malignant biliary obstruction.
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A Study of Caring Hand Massage for Cancer Patients Undergoing Chemotherapy in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.
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Ramucirumab And Paclitaxel Or FOLFIRI In Advanced Small Bowel Cancers
Rochester, MN
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop ...
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Study To Assess Enzastaurin + R-CHOP In Subjects With DLBCL With The Genomic Biomarker DGM1™
Rochester, MN
The purpose of this study is to enroll approximately 235 treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used to assess radiographic response at the end of treatment. Each subject's treatment assignment will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years.
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Measuring Cell Free DNA During The Course Of Treatment For Esophageal Cancer As A Marker Of Response And Recurrence
Rochester, MN
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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Nab-Paclitaxel And Bevacizumab In Treating Patients With Unresectable Stage IV Melanoma Or Gynecological Cancers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing ...
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Study Comparing CB-839 With Cabozantinib Vs. Cabozantinib With Placebo In Patients With Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.
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Adipose-Derived Mesenchymal Stem Cells (AMSCs) For Recurrent Glioblastoma
Jacksonville, FL
This study aims to evaluate the safety of local delivery of AMSCs for recurrent GBM by noting the incidence of adverse events, as well as radiological and clinical progression.
To assess the preliminary efficacy of local delivery of AMSCs for recurrent GBM by comparing the clinical, survival, progression, and radiographic outcomes from patients enrolled in our study to historical controls from our institution.
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A Study To Evaluate The Combination Of Margetuximab, Retifanlimab, MGD013, And Chemotherapy Phase 2/3 Trial In HER2+ Gastric/GEJ Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the effectiveness of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B).
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Optimizing Pancreatic Cancer Management Using Next Generation Imaging And Liquid Biopsy
Rochester, MN
The purpose of this study is to examine the relationship of ctDNA status and FDG PET/MRI findings with other clinicopathologic variables and standard staging examinations. We will develop a multivariable model combining ctDNA and FDG PET/MRI biomarkers to predict treatment response and survival. In addition, we will define the quantitative thresholds for early chemotherapy switch in patients who do not respond to first-line chemotherapy.
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De-Escalated Adjuvant And Definitive Radiation Therapy Informed By DART 2.0 CtHPV-DNA
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to prospectively incorporate ctHPVDNA in combination with clinical and pathologic factors to appropriately select patients for treatment intensity.
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A Study To Understand Symptoms From Olaparib
Rochester, MN
The purpose of this study is to gather real-world, patient-reported experiences of ovarian cancer patients who have been prescribed olaparib; this experience will be captured in patients’ own words with qualitative research methodology.
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A Study To Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients For T-cell Directed Immunotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate immune profile of Acute Myeloid Leukemia (AML) patients receiving Venetoclax plus Azacitidine induction chemotherapy.
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A Study Of Radiation Dosimetry, Safety, And Tolerability Of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment In Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
Rochester, MN
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
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A Study Of Bladder Filling Variations During Radiation Therapy In Patients Undergoing Radiation Treatment For Prostate Cancer
Jacksonville, FL
The purpose of this study is to examine bladder filling for radiation treatment to the prostate, and to evaluate how bladder fullness changes daily during radiation treatment.
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A Study Comparing Ibrutinib And Obinutuzumab With Or Without Venetoclax In Treating Patients With Chronic Lymphocytic Leukemia
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this trial is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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Nivolumab And Ipilimumab In Treating Patients With Esophageal And Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
Rochester, MN
The purpose of this study is to anayze the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy ...
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A Study To Evaluate Durvalumab Alone Or In Combination With Novel Agents In Subjects With NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
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A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...
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A Study To Test The Combination Of Cabozantinib, Nivolumab, And Ipilimumab (CaboNivoIpi) For Advanced Differentiated Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...
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JAB-3312 Based Combination Therapy In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.
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A 3D-Printed External Breast Prosthesis For The Improvement Of Patient-reported Outcomes Among Breast Cancer Patients That Underwent A Mastectomy Without Reconstruction
Rochester, MN
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is ...
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MC230302
Jacksonville, FL
This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).
Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).
Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial ...
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Estradiol In Treating Patients With ER Beta Positive, Triple Negative Locally Advanced Or Metastatic Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this trial is to determine how well estradiol works in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Hormone receptors like ER beta allow the body to respond appropriately to hormones. Triple negative means that the breast cancer does not express other hormone receptors called ER alpha, progesterone, and HER2. In some people with triple negative breast cancer, ER beta is overexpressed. Tumor cells that overexpress ER beta grow slower in the laboratory and ...
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A Study To Evaluate The Safety And Efficacy Of A2B530, A Logic-gated CAR T, In Subjects With Solid Tumors That Express CEA And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The purpose of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A*02 expression.
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A Study To Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) For Extensive Stage Small Cell Lung Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...
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A Study Of GC012F (AZD0120), A CAR T Therapy Targeting CD19 And BCMA In Subjects With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
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Study Of HPN536 In Patients With Advanced Cancers Associated With Mesothelin Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
To assess the safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D).
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Chemoradiation With Or Without Atezolizumab In Treating Patients With Limited Stage Small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Ixazomib Citrate, Lenalidomide, Dexamethasone, And Daratumumab In Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...
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Study Comparing Daratumumab, Lenalidomide, And Dexamethasone With Lenalidomide And Dexamethasone In Participants With Previously Untreated Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
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A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...
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A Study Of Belantamab Mafodotin (GSK2857916) In Multiple Myeloma Participants With Normal And Impaired Renal Function
Jacksonville, FL
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.
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Patient Survey of Molecular Breast Imaging
Rochester, MN
The purpose of this study is to gather qualitative information about patient comfort during MBI examinations. The primary aim is to assess patient comfort during MBI, relative to comfort during a mammogram. We also wish to identify factors that contribute to discomfort and patients’ willingness to have MBI in the future.
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A Study To Evaluate Gevokizumab With Standard Of Care Anti-cancer Therapies For Metastatic Colorectal, Gastroesophageal, And Renal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.
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Assessment Of The Safety, Ultrasound Conspicuity, And Migration Of Twinkling Markers In Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Systemic Therapy And Surgery, UTMOST Trial
Rochester, MN
In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally ...
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Testing The Role Of FDG-PET/CT To Predict Response To Therapy Prior To Surgery For HER2-positive Breast Cancer, The DIRECT Trial
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
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A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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A Study Of Low Dose Tamoxifen For Patients At High Risk For Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if counseling patients about low dose tamoxifen will influence the decision to take (or not take) preventive therapy among women at increased risk for breast cancer.
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A Study Of Using Palbociclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone For Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.
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Radiation Therapy With Or Without Androgen-Deprivation Therapy In Treating Patients With Prostate Cancer
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
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A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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A Study To Compare Nivolumab Or Brentuximab Vedotin Plus Combination Chemotherapy To Treat Patients With Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...
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Endoscopic Radiofrequency Ablation Induced Tumor Microenvironment Remodeling In Cholangiocarcinoma
Rochester, MN
The objective of the study is to study the systemic immunological effects of Radiofrequency Ablation in patients with advanced Extrahepatic cholangiocarcinoma.
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A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).
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Inotuzumab Ozogamicin And Post-Induction Chemotherapy In Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, And B-LLy
Rochester, MN
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...
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A Study Evaluating The Effectiveness Of Axicabtagene Ciloleucel Compared To Standard Of Care Therapy In Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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A Randomized Trial Of Pembrolizumab & Radiotherapy Versus Radiotherapy In High-Risk Soft Tissue Sarcoma Of The Extremity
Jacksonville, FL
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
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Effectiveness Of Mindfulness-Based Intervention On Patient Reported Outcomes Of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry
Jacksonville, FL
The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL.
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Urinebased Molecular Testing Versus Cystoscopy For Surveillance Of Nonmuscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate patient-reported preference for CxBladder Monitor compared to cystoscopy for patients on surveillance for NMIBC.
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Testing Proton Craniospinal Radiation Therapy Versus The Usual Radiation Therapy For Leptomeningeal Metastasis, RADIATE-LM Trial
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis).
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Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery
Eau Claire, WI
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
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Nilotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Scottsdale/Phoenix, AZ; Rochester, MN
In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people
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Effect Of Tumor Treating Fields (TTFields, 150 KHz) As Front-Line Treatment Of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine And Nab-paclitaxel (PANOVA-3)
Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Tumor Treating Fields (TTFields), in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic denocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Testing The Addition Of A New Drug, Venetoclax, To The Usual Treatment (Ibrutinib And Rituximab) For Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effects of ibrutinib and rituximab with or without venetoclax in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ...
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A Study To Assess The Effectiveness And Safety Of Ublituximab In Combination With Umbralisib And Venetoclax (U2-V) Compared To Ublituximab And Umbralisib (U2) In Subjects With Chronic Lymphocytic Leukemia (CLL)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the effectiveness and safety of ublituximab in combination with umbralisib and venetoclax compared to ublituximab and umbralisib in subjects with previously-treated chronic lymphocytic leukemia (CLL).
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Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
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A Study To Evaluate The Combination Of Binimetinib And Palbociclib In Treating Patients With KRAS And NRAS Mutant Metastatic Or Unresectable Colorectal Cancer
Scottsdale/Phoenix, AZ
The purose of this study is to determine how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib ...
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A Study To Evaluate Acalabrutinib With Or Without Obinutuzumab To Treat Early-Stage Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
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A Study Of To Evaluate Palbociclib In Combination With Letrozole And Trastuzumab In Stage II-III ER+ HER2+ Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer in order to influence estrogen receptor (ER) signaling.
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Endoscopic Radiofrequency Ablation Induced Tumor Microenvironment Remodeling In Cholangiocarcinoma
Rochester, MN
The objective of the study is to study the systemic immunological effects of Radiofrequency Ablation in patients with advanced Extrahepatic cholangiocarcinoma.
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Radiation Therapy With Or Without Androgen-Deprivation Therapy In Treating Patients With Prostate Cancer
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
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A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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A Study To Compare Nivolumab Or Brentuximab Vedotin Plus Combination Chemotherapy To Treat Patients With Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...
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A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma
Jacksonville, FL
The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).
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Inotuzumab Ozogamicin And Post-Induction Chemotherapy In Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, And B-LLy
Rochester, MN
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...
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A Study Evaluating The Effectiveness Of Axicabtagene Ciloleucel Compared To Standard Of Care Therapy In Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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A Randomized Trial Of Pembrolizumab & Radiotherapy Versus Radiotherapy In High-Risk Soft Tissue Sarcoma Of The Extremity
Jacksonville, FL
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
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Pembrolizumab And Ibrutinib In Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery
Rochester, MN
This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.
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Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)
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Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol To Reduce Incidence Of Heart Failure
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.
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A Study To Evaluate The Safety And Efficacy Of A2B530, A Logic-gated CAR T, In Subjects With Solid Tumors That Express CEA And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The purpose of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A*02 expression.
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A Study To Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) For Extensive Stage Small Cell Lung Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...
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A Study Of GC012F (AZD0120), A CAR T Therapy Targeting CD19 And BCMA In Subjects With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
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Study Of HPN536 In Patients With Advanced Cancers Associated With Mesothelin Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
To assess the safety and tolerability at increasing dose levels of HPN536 in successive cohorts of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2 dose (RP2D).
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Chemoradiation With Or Without Atezolizumab In Treating Patients With Limited Stage Small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Ixazomib Citrate, Lenalidomide, Dexamethasone, And Daratumumab In Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...
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Study Comparing Daratumumab, Lenalidomide, And Dexamethasone With Lenalidomide And Dexamethasone In Participants With Previously Untreated Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
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A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...
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A Study Of Belantamab Mafodotin (GSK2857916) In Multiple Myeloma Participants With Normal And Impaired Renal Function
Jacksonville, FL
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.
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Patient Survey of Molecular Breast Imaging
Rochester, MN
The purpose of this study is to gather qualitative information about patient comfort during MBI examinations. The primary aim is to assess patient comfort during MBI, relative to comfort during a mammogram. We also wish to identify factors that contribute to discomfort and patients’ willingness to have MBI in the future.
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Testing The Role Of FDG-PET/CT To Predict Response To Therapy Prior To Surgery For HER2-positive Breast Cancer, The DIRECT Trial
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
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Assessment Of The Safety, Ultrasound Conspicuity, And Migration Of Twinkling Markers In Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Systemic Therapy And Surgery, UTMOST Trial
Rochester, MN
In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally ...
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A Study To Evaluate Gevokizumab With Standard Of Care Anti-cancer Therapies For Metastatic Colorectal, Gastroesophageal, And Renal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.
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A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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A Study Of Low Dose Tamoxifen For Patients At High Risk For Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if counseling patients about low dose tamoxifen will influence the decision to take (or not take) preventive therapy among women at increased risk for breast cancer.
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A Study Of Using Palbociclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone For Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.
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A Study To Evaluate The Impact Of Non-invasive Tests For Bladder Cancer
Rochester, MN
Levels of bladder cancer-derived extracellular vesicles become undetectable after radical cystectomy in patients with localized bladder cancer. This study hopes to determine the levels of bladder cancer-derived extracellular vesicles pre- and post-RC.
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Trans-Pacific Multicenter Collaborative Study Of Minimally Invasive Proximal Versus Total Gastrectomy For Proximal Gastric And Gastroesophageal Junction Cancers
Rochester, MN
The purpose of this study is to compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
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HEADLIGHT: Hypofractionated Proton Therapy For Head And Neck Cancers
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This study utilizes a shorter course of radiotherapy for patients who need radiation after surgery or without surgery for head and neck cancers. Radiation is typically given in 6-7 weeks for head and neck cancer using X-ray therapy, but this study will administer treatment in approximately 3 weeks. To achieve this shorter course, proton therapy is used. This study aims to determine cancer control at 2 years after study registration. It also aims to determine the rate and duration of grade 3 or higher acute (defined from treatment start to 30 days from radiation completion date) adverse events ...
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Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.
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Bortezomib Or Carfilzomib With Lenalidomide And Dexamethasone In Treating Patients With Newly Diagnosed Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells
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Parotidectomy QOL Score
Rochester, MN
The objectives of this study are to explore the quality of life value of various surgical and functional outcomes after parotidectomy from a patient-centered perspective, develop a comprehensive patient-centered outcome measure after parotidectomy using a patient survey, and to validate the content of the above survey.
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A Study To Evaluate Tucatinib Plus Trastuzumab And Oxaliplatin-based Chemotherapy For HER2+ Gastrointestinal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.
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Mayo Clinic Cancer Center Neuro-Oncology Program Registry And Biobank For The Study Of Nervous System Tumors
Rochester, MN
Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.
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Fertility Outcomes in Lymphoma Patients
Jacksonville, FL
The objectives of this study are to analyze impact of radiation on fertility, to correlate the clinical outcome of fertility after chemotherapy and or radiation, and to evaluate the different modalities and cost/benefit of fertility preservation in lymphoma patients
Lymphoma is a diversified disease with outcomes differing upon the types and subtypes of lymphoma as well as treatment modalities used. Fertility outcomes in patients treated with chemotherapy and/or radiation could vary and largely unknown.
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IRB#21-009968: Assessing the Sexual Health and Well-Being of Female Survivors of Pelvic Malignancies after Radiotherapy
Rochester, MN
The purpose of this study is to quantify the extent of sexual dysfunction in our patients to explore if there is a need for a prospective intervention, with the ultimate goal of improving the quality of life of our patients, with respect to sexual function.
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MRI Techniques For Early-stage Detection Of Cancer
Rochester, MN
The purpose of this study is to develop 7T MRI techniques for early-stage detection of cancer, using both hydrogen (1H) and deuterium (2H) imaging.
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A Study Of Rilvegostomig Plus Chemotherapy As Adjuvant Therapy For Biliary Tract Cancer After Resection
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effictiveness and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
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Ultrasound-Guided Core Needle Biopsy To Stage Urothelial Carcinoma Of The Bladder (US UCB)
Rochester, MN
This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).
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A Study Of The Drugs Selumetinib Versus Carboplatin/Vincristine In Patients With Neurofibromatosis And Low-Grade Glioma
Rochester, MN
The pupose of this study is to evaluate whether or not selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by ...
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A Trial Of RAdium-223 And SABR Versus SABR For OligomEtastatic Prostate CaNcerS (RAVENS)
Rochester, MN
The primary purpose of this study is to assess progression-free survival of men who have oligometastatic prostate cancer after randomization to stereotactic ablative radiation therapy (SABR) versus SABR and Radium-223.
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Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
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A Study Of Vaccine Therapy In Treating Patients With Malignant Peripheral Nerve Sheath Tumors That Are Recurrent Or Cannot Be Removed By Surgery
Rochester, MN
The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).
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A Phase III, Safety, Tolerability And Efficacy Of Combination Treatment Of BL-8040 And G-GSF As Compared To Placebo And G-CSF For ThE MobilizatioN Of HematopoiEtic Stem Cells For Autologous TransplantatIon In SubjectS With MM
Rochester, MN
A total of 207 subjects will be randomized into the study which will employ a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
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A Study To Explore Quality Of Life According To Treatment Plan For Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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A Study To Evaluate Nutrition Therapy In Improving Immune System In Bladder Cancer Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
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A Phase I, Multi-Center, Open Label, Dose De-escalation And Expansion Study Of Gemcitabine And Cisplatin With AG120 Or Pemigatinib For Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib and pemigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for ...
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A Study Of Quality Of Life After Thyroid Cancer Surgery
Scottsdale/Phoenix, AZ
The purpose of this study is to create a prospectively maintained database of patient and clinical factors, as well as collect survey data using validated quality-of-life metrics, to determine the impact and factors associated with quality of life after thyroid surgery for thyroid cancer.
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Safety And Activity Of PolyPEPI1018 Plus Atezolizumab In Colorectal Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
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A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Rochester, MN
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
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A Study Of R-ICE And Lenalidomide For Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement and that has not responded to previous treatment. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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A Study To Evaluate Daratumumab And Ibrutinib To Treat Relapsed / Refractory Chronic Lymphocytic Leukemia Treatment (DIRECT)
Jacksonville, FL
For cohort 1: The primary goal is to the determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are on/or are previously treated with ibrutinib.
For Cohort 2: The primary goal is to determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are naive to ibrutinib treatment.
Secondary Goals:
For Cohort 1
-Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy.
-The overall incidence of MRD (minimal ...
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Cyclophosphamide and Vaccine Therapy in Treating Patients with Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This study is being done to gather information. The study will provide important information related to the safety and the effect of the vaccine on a patient's immune system. What researchers learn from this study could possibly be used in the future to prevent or delay recurrence of breast or ovarian cancers.
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Radiation Dermatitis In Breast Cancer Patients
Rochester, MN
The purpose of this study is to gather and analyze anonymous patient-reported experiences of radiation dermatitis in breast cancer patients undergoing radiotherapy.
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A Single Patient Study Of Severe Fibrosis After Breast Radiation
Rochester, MN
This study is being performed to better understand the mechanisms behind severe radiation toxicity of a patient with severe fibrosis after breast radiation.
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Alisertib With Or Without Fulvestrant In Treating Patients With Locally Advanced Or Metastatic, Endocrine-Resistant Breast Cancer
Rochester, MN
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.
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Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP In Newly Diagnosed High-intermediate And High Risk DLBCL Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL.
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Targeted Therapy Directed By Genetic Testing In Treating Patients With Locally Advanced Or Advanced Solid Tumors, The ComboMATCH Registration Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. P
atients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) ...
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A Study Of Multiple Therapies In Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.
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Erlotinib with or without Bevacizumab in Treating Patients with Stage IV Non-Small Cell Lung Cancer with EGFR Mutations
Rochester, MN
This randomized phase II trial studies how well giving erlotinib (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether erlotinib is more effective when given alone or with bevacizumab.
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Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone ...
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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Mankato, MN
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
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Self-Collection For Cervical Cancer Screening And HPV Vaccination For Cancer Prevention Among Women In Emergency Care In Northeast Florida
Jacksonville, FL
The purpose of this study is to reduce disparities in cervical cancer screening and mortality among women vulnerable to health disparities based on social determinants of health. We are specifically interested in identifying non-traditional sites for cervical cancer screening and education regarding HPV vaccination outside of the primary care and gynecologic clinic settings.
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A Study To Evaluate Gilteritinib Vs. Midostaurin In FLT3 Mutated Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML.
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REFINE: Regorafenib Observational Study In Hepatocellular Carcinoma
Rochester, MN
The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.
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A Study Evaluating The Efficacy Of Venetoclax Plus Ibrutinib In Subjects With T-cell Prolymphocytic Leukemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows:
Stage 1: Enroll up to 14 participants and move to Stage 2 if 4 or more subjects meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.
Stage 2: Enroll up to an additional 23 participants with previously untreated or relapsed or refractory T-PLL.
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A Study Investigating The Safety, Tolerability, Pharmacokinetics, And Effectiveness Of Mosunetuzumab (BTCT4465A) In Combination With CHOP Or CHP-Polatuzumab Vedotin In Participants With B-Cell Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics, and preliminary effectiveness of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
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DSC-MRI In Measuring Relative Cerebral Blood Volume For Early Response To Bevacizumab In Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.
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Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
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Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Jacksonville, FL
The purpose of this study is to evaluate the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery
Eau Claire, WI
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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The Mayo Clinic Breast Disease Survivors Study
Rochester, MN
This study will recruit breast cancer patients and survivors to take part in an ongoing study of the issues and concerns surrounding breast cancer survivorship. We will recruit both newly diagnosed patients as well as patients diagnosed within the past 5 years. Those who consent to the study will be asked to provide a series of questionnaires and blood samples over time. These data/samples will create a repository that will enable us to address many specific hypotheses both now and in the future. As part of the study DNA samples will be genotyped for common genetic variants ...
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A Study of the Ability to Predict Lymphedema Development Following Axillary Surgery for Breast Cancer and Its Effects on Patient Survivorship
Jacksonville, FL
The purpose of this study is to better understand the anatomy of the lymphatic structure and the molecular process that leads to the over production of lymph fluid. This proposal will begin intense lymphedema screening and identify baseline characteristics potentially predisposing someone to lymphedema, and identify molecular markers that might be altered to prevent lymphedema.
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A Study Of Taxane, Trastuzumab, And Pertuzumab With Or Without Atezolizumab In Treating Metastatic Breast Cancer Patients
Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ...
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A Study To Evaluate Decreasing Chemotherapy For Breast Cancer Patients After Pre-surgery Chemo And Targeted Therapy
Eau Claire, WI; La Crosse, WI; Rochester, MN
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on ...
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A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy
Jacksonville, FL
This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.
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A Study Comparing Combinations of Chemotherapy for Treating Women who have Undergone Surgery for Node-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare three different combination chemotherapy regimens and evaluate how well they work in treating women who have undergone surgery for node-positive breast cancer. Drugs used in chemotherapy, such as docetaxel, doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
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Family Cancer Literacy to Promote Mammography Screening among Navajo Women
Rochester, MN
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.
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Study to Evaluate Effects of Pre-Surgery Therapy on Direct-to-Implant Reconstruction as Compared to Immediate Tissue Expander-Based Reconstruction
Rochester, MN
The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.
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A Study To Quantify Microvasculature Imaging For Breast Cancer Detection And Monitoring
Rochester, MN
The purpose of this study is to apply new microvasculature imaging for differentiation of breast lesions, and prediction of response to preoperative chemotherapy.
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GENetic Risk Estimation Of Breast Cancer Prior To Decisions On Preventive Therapy Uptake, Risk Reducing Surgery Or Intensive Imaging Surveillance
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; Jacksonville, FL; Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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A Study To Evaluate Abemaciclib For Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.
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Study To Evaluate Chemoembolization Combined With Durvalumab And Bevacizumab Therapy In Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus works in treating patients with breast cancer.
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A Study Of Hypofractionated Radiotherapy To The Whole Breast Alone Before Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.
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Tamoxifen Citrate, Letrozole, Anastrozole, Or Exemestane With Or Without Chemotherapy In Treating Patients With Invasive RxPONDER Breast Cancer
Mankato, MN
This study is being reopened with Mayo IRB for long-term follow-up data purposes only. The initial study IRB# 12-009536 was "completed" prematurely as not all data collection activities had been completed. This study was always separately filed in Rochester and Mankato with two different PIs. Rochester is still open and Mankato was completed prematurely.
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A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives for this study are:
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss ...
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A Study Comparing Combinations of Chemotherapy for Treating Women who have Undergone Surgery for Node-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare three different combination chemotherapy regimens and evaluate how well they work in treating women who have undergone surgery for node-positive breast cancer. Drugs used in chemotherapy, such as docetaxel, doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
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Dendritic Cell Therapy, Cryosurgery, And Pembrolizumab In Treating Patients With Non-Hodgkin Lymphoma
Rochester, MN
This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and pembrolizumab may work better at treating non-Hodgkin lymphoma.
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Study Of Endocrine Therapy With Or Without Abemaciclib (LY2835219) Following Surgery In Participants With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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Family Cancer Literacy to Promote Mammography Screening among Navajo Women
Rochester, MN
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.
-
Study to Evaluate Effects of Pre-Surgery Therapy on Direct-to-Implant Reconstruction as Compared to Immediate Tissue Expander-Based Reconstruction
Rochester, MN
The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.
-
A Study To Quantify Microvasculature Imaging For Breast Cancer Detection And Monitoring
Rochester, MN
The purpose of this study is to apply new microvasculature imaging for differentiation of breast lesions, and prediction of response to preoperative chemotherapy.
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GENetic Risk Estimation Of Breast Cancer Prior To Decisions On Preventive Therapy Uptake, Risk Reducing Surgery Or Intensive Imaging Surveillance
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; Jacksonville, FL; Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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A Study To Evaluate Abemaciclib For Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.
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A Study Of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) In Postmenopausal Women With Breast Cancer
Rochester, MN
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
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A Study To See If Genetic Risk Estimation Of Breast Cancer Influences The Use Of Preventive Medication
Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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A Study Of Pembrolizumab And Ruxolitinib Phosphate For Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab for treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.
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Standard Or Comprehensive Radiation Therapy In Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy And Surgery
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.
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Study To Evaluate Chemoembolization Combined With Durvalumab And Bevacizumab Therapy In Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus works in treating patients with breast cancer.
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A Study Of Hypofractionated Radiotherapy To The Whole Breast Alone Before Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.
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Tamoxifen Citrate, Letrozole, Anastrozole, Or Exemestane With Or Without Chemotherapy In Treating Patients With Invasive RxPONDER Breast Cancer
Mankato, MN
This study is being reopened with Mayo IRB for long-term follow-up data purposes only. The initial study IRB# 12-009536 was "completed" prematurely as not all data collection activities had been completed. This study was always separately filed in Rochester and Mankato with two different PIs. Rochester is still open and Mankato was completed prematurely.
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A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives for this study are:
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss ...
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Dendritic Cell Therapy After Cryosurgery In Combination With Pembrolizumab In Treating Patients With Stage III-IV Melanoma That Cannot Be Remove By Surgery
Rochester, MN
This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients ...
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Letrozole in Treating Postmenopausal Women with Ductal Carcinoma in Situ
Rochester, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice In Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery And Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
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Pre-Op / Post-Op Hypofractionation Radiotherapy In Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of ths study is to determine the outcomes and toxicity profile of preoperative treatment including chemotherapy and hypofractionated radiotherapy for different breast cancer risk groups.
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Cancer Prevention: Stories For Change In Hispanic Community
Rochester, MN
This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.
This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.
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Evaluating Surgical Treatment Related Differences In Patient Satisfaction And Health-related Quality Of Life In Breast Cancer Survivors In The Long-term Survivorship Period
Rochester, MN
This study is being done to determine the long-term effects of different kinds of breast surgeries on women’s health-related quality of life from the patient’s perspective. The information will also provide information to assist in improving the quality of care given to patients.
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Randomized, Open Label, Clinical Study Of The Targeted Therapy, Palbociclib, To Treat Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
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A Study To Compare Administering Olaparib Concurrently With Radiotherapy Vs. Radiotherapy Alone In Treating Patients With Inflammatory Breast Cancer
Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
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Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors
Albert Lea, MN; Mankato, MN; Rochester, MN
This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and ...
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Eliminating Breast Cancer Surgery In Exceptional Responders With Neoadjuvant Systemic Therapy
Rochester, MN
The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.
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Breast Cancer, Reasoning, And Activity Intervention
Scottsdale/Phoenix, AZ
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health ...
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Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection
Rochester, MN
The objectives of this study are to determine the impact of omega-3 supplementation on promoting facial nerve function recovery, and to determine the impact of omega-3 supplementation on Vestibular schwannoma (VS) tumor control.
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Testing The Role Of DNA Released From Tumor Cells Into The Blood In Guiding The Use Of Immunotherapy After Surgical Removal Of The Bladder, Kidney, Ureter, And Urethra For Urothelial Cancer Treatment, MODERN Study
Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are ...
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Intratumoral Extracellular Metabolic Impact Of DFMO And AMXT 1501 In Patients With Diffuse Or High Grade Glioma
Rochester, MN
The purpose of this study is to determine how polyamine depletion impacts extracellular intratumoral guanidinoacetate abundance.
In addition: to determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ; to assess the feasibility of longitudinal microdialysis for combined pharmacokinetic and pharmacodynamic analysis within live human gliomas in situ in the postoperative setting; to assess the CNS pharmacokinetics of DFMO and AMXT 1501; to assess the short-term safety of study drugs in patients with high-grade gliomas.
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Study Of Gastric Cancer And Limited Peritoneal Metastasis Using Robotic Cytoreduction And Hyperthermic Intraperitoneal Chemotherapy
Rochester, MN
The purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.
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Embolization Before Ablation Of Renal Cell Carcinoma (EMBARC)"
Rochester, MN
The purpose of this study is to estimate the safety of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma, and to estimate the feasibility of patient enrollment in such a trial.
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A Study Of Siremadlin Alone And In Combination With Donor Lymphocyte Infusion In Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
Jacksonville, FL
The purpose of this study is to confirm a safe dose and schedule as well as the preliminary effectiveness of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with acute myeloid leukemia (AML) who are in remission following allogeneic stem cell transplantation (allo-SCT) but are at high risk for relapse based on the presence of pre-transplant risk factors.
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A Study Of Heated Intra-peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin And Cisplatin In Pediatric Patients With Pelvic And Abdominal Rhabdomyosarcoma
Rochester, MN
The primary purpose of this study is to assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and Cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors, and to assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy.
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A Study To Evaluate The Safety, Effectiveness And Tolerable Dose Of Arlocabtagene Autoleucel (BMS-986393) In Novel Combinations In Participants With Relapsed And/or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
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Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.
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Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate The Reservoir]
La Crosse, WI; Rochester, MN
The significance of this study is that it will be the first prospective trial to compare MBI, a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic breast cancer screening technique in women with dense breasts. This study is also the first to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation after introduction of a functional imaging technique. These data will inform individualized decisions on supplemental screening and determine if a functional technique that is relatively low in cost and complexity of interpretation can eliminate the reservoir of clinically important breast cancers ...
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A Study To Investigate The Effects Of GC4419 On Radiation-Induced Oral Mucositis In Patients With Head/Neck Cancer
Jacksonville, FL
The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
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MelmarT Melanoma Margins Trial Investigating 1cm V 2cm Wide Excision Margins For Primary Cutaneous Melanoma (MelMarT)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life to back up evidence that less radical margins of excision may be just as safe.
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Congenital Heart Disease Skin Punch Biopsy Sample Collection
Rochester, MN
The purpose of this study is to Generate autologous iPSC in a manner compliant with requirements for future clinical use, and Reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
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Hypofractionated Pre-Operative Radiation Therapy For Localized, Resectable Soft Tissue Sarcoma Of The Extremity Or Superficial Trunk
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...
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A Study to Collect Ovarian Tissue from Girls Undergoing Fertility-preserving Cryopreservation
Rochester, MN
The purpose of this study is to study the handling of ovarian tissue, cryopreservation technology, and oocyte maturation for female pediatric cancer patients and other female patients whose future fertility will be affected due to a disease or treatment.
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A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma
Scottsdale/Phoenix, AZ
The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma. MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.
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Safety And Efficacy Of ALLO-605 An Anti-BCMA Allogeneic CAR T Cell Therapy In Patients With Relapsed/Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of the ALLO-605-201 study is to assess the safety, effectiveness, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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Study To Evaluate The Efficacy And Safety Of Lutathera In Patients With Grade 2 And Grade 3 Advanced GEP-NET
Rochester, MN
The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
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Bispecific Aptamer Engagers For Cancer Therapy
Jacksonville, FL
The purpose of this work is to develop brain cancer-specific small synthetic oligonucleotides (aptamers) that easily cross the BBB and capable of forming distinct three-dimensional configurations, enabling them to bind to target molecules with high affinity and specificity. The scope of this work is to develop brain cancer specific aptamers and combine them with patient-derived autologous T cells to enhance the tumor targeted immune reaction.
Our three major project aims are the creation of the Bispecific Aptamer T Cell Engagers (BATE) (aim 1), the creation of autologous T cell – BATE (aim 2), and finally the combination ...
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Pivotal Study Of The NanoKnife System For The Ablation Of Prostate Tissue
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate The Reservoir]
La Crosse, WI; Rochester, MN
The significance of this study is that it will be the first prospective trial to compare MBI, a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic breast cancer screening technique in women with dense breasts. This study is also the first to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation after introduction of a functional imaging technique. These data will inform individualized decisions on supplemental screening and determine if a functional technique that is relatively low in cost and complexity of interpretation can eliminate the reservoir of clinically important breast cancers ...
-
A Study To Investigate The Effects Of GC4419 On Radiation-Induced Oral Mucositis In Patients With Head/Neck Cancer
Jacksonville, FL
The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
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Bispecific Aptamer Engagers For Cancer Therapy
Jacksonville, FL
The purpose of this work is to develop brain cancer-specific small synthetic oligonucleotides (aptamers) that easily cross the BBB and capable of forming distinct three-dimensional configurations, enabling them to bind to target molecules with high affinity and specificity. The scope of this work is to develop brain cancer specific aptamers and combine them with patient-derived autologous T cells to enhance the tumor targeted immune reaction.
Our three major project aims are the creation of the Bispecific Aptamer T Cell Engagers (BATE) (aim 1), the creation of autologous T cell – BATE (aim 2), and finally the combination ...
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Pivotal Study Of The NanoKnife System For The Ablation Of Prostate Tissue
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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A Study of the Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study will utilize Rasch analysis to study the construct validity and reliability of five shoulder-related patient-reported outcome measures in patients reporting shoulder impairment following surgery for head and neck cancer.
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A Study To Determine How BI 907828 Is Taken Up In The Tumor And To Determine The Highest Dose Of BI 907828 That Could Be Tolerated In Combination With Radiation Therapy In People With A Brain Tumor Called Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.
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Image-based Mapping Of Brain Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.
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A Safety To Evaluate The Safety And Effectiveness Of Pressurized Intraperitoneal Aerosolized Chemotherapy In Ovarian, Uterine, Colorectal, And Gastric Cancer Patients
Jacksonville, FL
The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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A Study Of Clonal Hematopoiesis (CH) And Hematological Toxicity After Cancer Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.
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A Study for Cerebral Open Flow Microperfusion
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research’s cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
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A Study To Evaluate Stereotactic Radiosurgery Versus Hippocampal-Avoidant Whole Brain Radiotherapy For 10 Or Fewer Brain Metastases From Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test – Revised (HVLT-R), Controled Oral Word Association (COWA) test, and the Trail Making Test (TMT).
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MV-NIS Infected Mesenchymal Stem Cells In Treating Patients With Recurrent Ovarian Cancer
Rochester, MN
This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with recurrent ovarian cancer. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells.
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AUTO1 In Relapsed Or Refractory B-ALL
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AUTO1 (t-cells) in adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (r/r B-ALL).
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Nurse-Led Acupressure Intervention For Patients Receiving Chemotherapy
Rochester, MN
The purpose of this study is to evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy.
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Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy In Early-Stage Resectable NSCLC (VIGOR)
Rochester, MN
The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
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Study Of Iomab-B Prior To HCT Vs. Conventional Care In Older Subjects With Active, Relapsed Or Refractory AML
Jacksonville, FL; Rochester, MN
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.
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Phase 2b Study Of GC4711 In Combination With SBRT For Nonmetastatic Pancreatic Cancer
Rochester, MN
The purpose of this study is to to determine the effect to overall survival (OS) by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic.
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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FRACTIONATE
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately. The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials. Although this cohort was enrolled on the prospective phase I trial from ...
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A Study To Evaluate Individualized Prehabilitation For People Undergoing Neo-Adjuvant Radiotherapy And Lower Limb Soft-Tissue Sarcoma Surgery
Scottsdale/Phoenix, AZ
The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.
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A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Rochester, MN
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...
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A Study To Evaluate Ruxolitinib For The Treatment Of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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A Study To Assess Cisplatin And Combination Chemotherapy In Treating Children And Young Adults With Hepatoblastoma Or Liver Cancer After Surgery
Rochester, MN
The purpose of this study is to determine how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.
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A Study To Evaluate Tacrolimus/Methotrexate Versus Post-Transplant Cyclophosphamide/ Tacrolimus/Mycophenolate Mofetil In Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to compare 1 year graft-versus-host disease (GVHD)-free, graft relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.
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A Study To Compare Stereotactic Radiosurgery To Hippocampal-Avoidant Whole Brain Radiotherapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 or more brain metastases.
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A Study to Evaluate Chemotherapy and Radiation Therapy With or Without Surgery to Treat Patients With Head and Neck Cancer
Rochester, MN
The purpose of this study is to determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC, to assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens, to define the acute and late toxicity of each treatment regimen, to evaluate whether there are differences in patient’s QOL, perception of side effects, and performance status between treatment arms, to establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation.
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A Study To Evaluate 68Ga- PSMA-Dual Contrast PET/MRI And PET/CT For Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.
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A Study To Evaluate Advanced Development Of Desorption Electrospray Ionization Mass Spectrometry For Intraoperative Molecular Diagnosis Of Brain Cancer
Jacksonville, FL
The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.
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Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy For Salvage Of Biochemically Recurrent Or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.
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Electron Beam Intraoperative Radiation Therapy Following Chemoradiation In Patients With Pancreatic Cancer With Vascular Involvement (PACER)
Jacksonville, FL; Rochester, MN
The purpose of this study is to to evaluate the rate of overall survival (OS) at two years in patients with either borderline or locally advanced pancreatic cancer who receive electron beam intraoperative radiation therapy (IORT) following chemotherapy and radiation therapy.
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Human Blood and Tissues Repository for Neuroscience Research
Jacksonville, FL
The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).
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Study Of [68Ga]FAPI-46 PET In Patients With Pancreatic Ductal Carcinoma
Rochester, MN
The purpose of this study is to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection.
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A Study To Evaluate Optune Vs. Prophylactic Cranial Irradiation (PCI) In Non-Small Cell Lung Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and preliminary effectiveness of Optune®-Tumor Treating Fields (TTFields) therapy vs. Prophylactic Cranial Irradiation (PCI) in Small Cell Lung Cancer (SCLC), a common disease with a high propensity for brain metastases. Prophylactic cranial irradiation (PCI) is a standard therapy for reducing the risk of SCLC brain metastases. While PCI is associated with added survival benefit to patients with SCLC, the approach is associated with both acute and long-term toxicity. As an alternative treatment option, directed electrical fields to the brain using the Optune® device is associated with decreasing the risk of tumor progression ...
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Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation For Children, Adolescents, And Young Adults With Acute Leukemia Or Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to compare the 1-year cumulative incidence of severe GVHD (from day of HCT) defined as Grade III-IV acute GVHD (aGVHD) and/or chronic GVHD (cGVHD) that requires systemic immunosuppression and to compare the disease free survival (DFS) (from time of randomization) in children and young adults (AYA) with acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), and Myelodysplastic Syndrome (MDS) who are randomly assigned to haploHCT or to an 8/8 adult MUD HCT.
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Selection Of Allogeneic Hematopoietic Cell Donors Based On KIR And HLA Genotypes
Rochester, MN
The purpose of this study is to test whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA). Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will ...
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Effects of Cognitive Function, Post-op Fatigue and Quality of Life Comparing General vs Regional Anesthesia for Non-eloquent Brain Tumors Resection
Jacksonville, FL
The aim of the study is to create a registry to prospectively collect pre-operative, during surgery and post-operative data, questionaries will assess (at baseline before the surgery, 3-4 weeks, and at 3-6 months) cognitive function, assessed with a Mini-mental State Examination (MMSE), PROMIS Fatigue 7a form, quality of life (QoL), assessed using the SF-12 questionnaire, quality of sleep assessed using PROMIS Sleep disturbance 7a form (1 week after surgery).
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AML: Treatment Of Relapse After Transplant Or Extended Maintenance Of Remission – Investigational Study (ARTEMIS)
Effectiveness Of MT-401 In Patients With AML Following Stem Cell Transplant
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate safety and effectiveness of MT-401 administration to patients with AML, who have received their first allogeneic HSCT.
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Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Rochester, MN
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.
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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients with Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
Rochester, MN
This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare ...
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A Study To Evaluate The Optune® (Tumor Treating Fields) Concomitant With RT & TMZ To Treat Newly-diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
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A Study To Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant In Participants With Newly Diagnosed Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
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PRGN-3006 Adoptive Cellular Therapy For CD33-Positive Relapsed Or Refractory AML, MRD Positive AML Or Higher Risk MDS
Rochester, MN
The purpose of this study is to determine the safety and best dose of PRGN-3006 T Cells to treat relapsed/refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome.
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Pituitary tumor registry
Rochester, MN
The purpose of this data registry involves the collection of standard of care clinical treatment regimens, diagnostic information and surgical outcomes which may include human specimens and associated genomewide expression data.
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A Study Of Ruxolitinib For The Treatment Of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Rochester, MN
The purpose of this study is to provide ruxolitinib through an expanded access program in the United States for the treatment of graft-versus-host disease (GVHD) in patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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A Study To Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.
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Study Of NanoKnife For Ablation Of Prostate Cancer In Low And Intermediate Risk Patients
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Leveraging AI/ML Algorithms On Digital Pathology And Ex-Vivo Confocal Microscopy Imaging For Extramammary Paget’s Disease
Rochester, MN
The purpose of this study is to validate the use of ex-vivo confocal microscopy for the assessment of skin specimens derived from Mohs surgery compared to standard microscopy. To leverage deep learning models for classification, detection, and localization of tumor for extramammary Paget’s disease on ex-vivo confocal microscopy images. To leverage AI/ML to ex-vivo confocal microscopy imaging to facilitate microscopic-level imaging of extramammary Paget’s disease. To leverage deep learning models for classification, detection, and localization of tumor for extramammary Paget’s disease on frozen and permanent pathology WSIs.
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A Study Of Lutetium Lu 177 Dotatate (Lutathera®) In Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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A Study Of Cannabis Withdrawal In Hospitalized Patients With Hematological Malignancies Undergoing Bone Marrow Transplant (BMT) Or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the prevalence of cannabis withdrawal and to characterize the clinical manifestations of cannabis withdrawal syndrome in patients hospitalized for BMT or CAR-T therapy.
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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PRGN-3006 Adoptive Cellular Therapy For CD33-Positive Relapsed Or Refractory AML, MRD Positive AML Or Higher Risk MDS
Rochester, MN
The purpose of this study is to determine the safety and best dose of PRGN-3006 T Cells to treat relapsed/refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome.
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Pituitary tumor registry
Rochester, MN
The purpose of this data registry involves the collection of standard of care clinical treatment regimens, diagnostic information and surgical outcomes which may include human specimens and associated genomewide expression data.
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A Study Of Ruxolitinib For The Treatment Of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Rochester, MN
The purpose of this study is to provide ruxolitinib through an expanded access program in the United States for the treatment of graft-versus-host disease (GVHD) in patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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A Study To Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.
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Study Of NanoKnife For Ablation Of Prostate Cancer In Low And Intermediate Risk Patients
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Leveraging AI/ML Algorithms On Digital Pathology And Ex-Vivo Confocal Microscopy Imaging For Extramammary Paget’s Disease
Rochester, MN
The purpose of this study is to validate the use of ex-vivo confocal microscopy for the assessment of skin specimens derived from Mohs surgery compared to standard microscopy. To leverage deep learning models for classification, detection, and localization of tumor for extramammary Paget’s disease on ex-vivo confocal microscopy images. To leverage AI/ML to ex-vivo confocal microscopy imaging to facilitate microscopic-level imaging of extramammary Paget’s disease. To leverage deep learning models for classification, detection, and localization of tumor for extramammary Paget’s disease on frozen and permanent pathology WSIs.
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A Study Of Lutetium Lu 177 Dotatate (Lutathera®) In Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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A Study Of Cannabis Withdrawal In Hospitalized Patients With Hematological Malignancies Undergoing Bone Marrow Transplant (BMT) Or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the prevalence of cannabis withdrawal and to characterize the clinical manifestations of cannabis withdrawal syndrome in patients hospitalized for BMT or CAR-T therapy.
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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BeWell360-CG Care Model: Health And Wellness Coaching To Support Caregivers Of Patients Living With Advanced Lung Cancers
Jacksonville, FL
Piloting the BeWell360-CG model, in conjunction with usual care delivery for lung cancer patients in Palliative Care, will longitudinally improve the wellbeing and quality of life of care givers within and outside of clinical care settings, in such a way as to positively impact the quality of care of patients themselves. We hypothesize that PC staff trained in the BeWell360-CG will be able to identify the most common CG-centric needs and guide CGs to improve their QoL and personal wellbeing. In doing so, we further hypothesize that there will be an improvement in patient-reported and quality of care ...
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Oligomets Pancreas SBRT
Jacksonville, FL
The primary endpoint for this study will compare PFS between SBRT + standard chemotherapy vs. standard chemotherapy alone in patients with oligometastatic pancreatic cancer. PFS is defined as the time from randomization to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria and will be documented at each enrolling site with no central review planned.
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Study To Determine The Impact Of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (A Chemical Tracer That Highlights Certain Cells During Imaging) During Planning For Proton Beam Radiation Therapy.
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.
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Ommaya Placement For Biomarker Collection
Rochester, MN
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.
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LS138D, Rituximab With Or Without Yttrium Y-90 Ibritumomab Tiuxetan In Treating Patients With Untreated Follicular Lymphoma
Rochester, MN
This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to see how well they work compared to rituximab alone in treating patients with untreated follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer cells and give off radiation which may help kill cancer cells. It is not yet known whether rituximab is more effective with or without yttrium Y-90 ibritumomab tiuxetan in treating follicular lymphoma.
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Efficacy And Safety Study Of Bb2121 In Subjects With Relapsed And Refractory Multiple Myeloma (KarMMa)
Rochester, MN
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
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A Study In Treating Patients With Kidney Cancer Undergoing Nephrectomy Comparing PERioperative Nivolumab Vs. Observation
Rochester, MN
The purpose of this randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone ...
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A Study To Evaluate The Safety And Effectiveness Of Lisocatagene Maraleucel In Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.
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A Study To Evaluate The Da Vinci® Xi™ Surgical System In Nipple Sparing Mastectomy (NSM) Procedures
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.
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FT819 In Subjects With B-cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, and clinical activity of FT819 in r/r B-cell malignancies, including the effect of a step-fractionated dosing schedule on mitigating safety risks and improving tolerability.
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A Study To Compare The Effectiveness And Safety Of Bb2121 Versus Standard Regimens In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).
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A Study To Assess The Effectiveness And Safety Of Durvalumab Alone Or Combined With Bevacizumab In High Risk Of Recurrence HCC Patients After Curative Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.
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Long-Term Follow-up Protocol For Participants Treated With Gene-Modified T Cells
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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A Study To Evaluate The Safety Of Bb2121 In Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM) (KarMMa-4)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and to determine the optimal dose of bb2121 in subjects with high risk, (HR) newly -diagnosed multiple myeloma (NDMM).
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A Study To Evaluate The Safety And Effectiveness Of Idecabtagene Vicleucel To Treat Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information.
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A Study Comparing Abemaciclib Plus Temozolomide To Temozolomide Monotherapy In Children And Young Adults With High-grade Glioma Following Radiotherapy
Rochester, MN
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
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A Study To Compare The Effectiveness And Safety Of JCAR017 To Standard Of Care In Adult Subjects With High-risk, Transplant-eligible Relapsed Or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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A Study To Compare Durvalumab Vs Placebo Following Stereotactic Body Radiation Therapy In Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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A Study To Evaluate Chemoradiotherapy With Or Without Atezolizumab In Treating Patients With Localized Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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Dose-Reduced Consolidation Radiation Therapy In Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).
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A Study Of Nivolumab And Multi-fraction Stereotactic Radiosurgery With Or Without Ipilimumab In Treating Participants With Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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Spearhead 1 Study In Subjects With Advanced Synovial Sarcoma Or Myxoid/Round Cell Liposarcoma
Jacksonville, FL
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
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Safety And Efficacy Of ALLO-715 And ALLO-647 BCMA Allogenic CAR T Cells In In Adults With Relapsed Or Refractory Multiple Myeloma (UNIVERSAL)
Rochester, MN
The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.
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Ablation With Confirmation Of Colorectal Liver Metastases (ACCLAIM)
Rochester, MN
The purpose of this study is to demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
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Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this stduy is to examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
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CD19-Directed CAR-T Cell Therapy For The Treatment Of Relapsed/Refractory B Cell Malignancies
Rochester, MN
The purpose of this study is to find out more about the side effects of the CAR-T therapy called IC19/1563 and what dose of IC19/1563 is safe for patients.
The therapy, IC19/1563, uses some of the patients own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. In this study, some of the patient's T cells will be removed from their blood. In the laboratory, we will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat the cancer. The new modified ...
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SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy In Adults With CD33 And/or FLT3 Blood Cancers Including AML/MDS
Jacksonville, FL
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.
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A Study Of Apalutamide In Participants With High‑Risk, Localized Or Locally Advanced Prostate Cancer Who Are Candidates For Radical Prostatectomy
Jacksonville, FL
The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.
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A Study To Evaluate The Feasibility Of Daily, Long-Term, Intermittent Fasting For Men On PSA Surveillance Following Radical Prostatectomy
Rochester, MN
The purpose of this study is to determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen, and to measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer.
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Aggressive Smoldering Curative Approach Evaluating Novel Therapies And Transplant
Rochester, MN
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
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A Study To Evaluate CC-98633 To Treat Subjects With Relapsed And/or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this Phase 1 first-in human study is to evaluate the safety and preliminary efficacy of CC-98633 in adult subjects with relapsed and/or refractory MM. A challenge in CAR T-cell development is to generate a product that consistently expands, persists, and mediates durable antitumor responses after infusion. Multiple preclinical and translational studies have suggested that the differentiation state of adoptively transferred T cells can influence the ability of these cells to persist and promote durable antitumor immunity. Less differentiated T cells have shown an increased ability to proliferate, persist, and mediate responses in mouse tumor models compared to more differentiated effector memory cell subsets in certain studies.
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A Study To Evaluate Daratumumab/rHuPh20 +/- Lenalidomide As Post-ASCT Maintenance For Multiple Myeloma With Minimal Residual Disease (MRD) To Direct Therapy Duration
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.
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Open Nipple Sparing Mastectomy (NSM)
Rochester, MN
The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.
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Conventionally Fractionated Vs. Hypofractionated
Comprehensive Nodal Irradiation For Breast Cancer Using Pencil Beam Scanning ProtonTherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if the 2-year rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated pencil beam scanning proton therapy (PBS-PT) is non-inferior to conventionally-fractionated PBS-PT.
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A Consortium Trial To Evaluate Proton Vs. Photon Therapy For Patients With Non-metastatic Breast Cancer
Jacksonville, FL
The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.
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A Study To Evaluate The Safety And Effectiveness Of ALLO-501A CAR T Cell Therapy In Adults With Relapsed/
Refractory Large B Cell Lymphoma
Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).
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Stereotactic Body Radiation Therapy With Immunotherapy For The Treatment Of Mesothelioma
Rochester, MN
The purpose of this study is to evaluate whether adding stereotactic body radiation therapy (SBRT) to immunotherapy as part of second line treatment for mesothelioma will improve the modest response rate of immunotherapy alone, provide local control/cytoreduction to sites of gross disease, and decrease symptomatic burden while improving outcomes.
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Study To Evaluate The Safety And Effectiveness Of Axicabtagene Ciloleucel In Combination With Utomilumab In Adults With Relapsed/Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward from Phase 1 into Phase 2, and to evaluate the effectiveness of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma in Phase 2.
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Open-label, Multi-center, Phase 1b/2 Clinical Trial To Evaluate The Safety And Efficacy Of Autologous CAR-BCMA T-cells (CT053) In Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.
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A Multi-Center Study Evaluating KTE-X19 In Pediatric And Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.
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A Study Of Apalutamide In Participants With High‑Risk, Localized Or Locally Advanced Prostate Cancer Who Are Candidates For Radical Prostatectomy
Jacksonville, FL
The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.
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A Study To Evaluate The Feasibility Of Daily, Long-Term, Intermittent Fasting For Men On PSA Surveillance Following Radical Prostatectomy
Rochester, MN
The purpose of this study is to determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen, and to measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer.
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A Study To Evaluate CC-98633 To Treat Subjects With Relapsed And/or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this Phase 1 first-in human study is to evaluate the safety and preliminary efficacy of CC-98633 in adult subjects with relapsed and/or refractory MM. A challenge in CAR T-cell development is to generate a product that consistently expands, persists, and mediates durable antitumor responses after infusion. Multiple preclinical and translational studies have suggested that the differentiation state of adoptively transferred T cells can influence the ability of these cells to persist and promote durable antitumor immunity. Less differentiated T cells have shown an increased ability to proliferate, persist, and mediate responses in mouse tumor models compared to more differentiated effector memory cell subsets in certain studies.
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Aggressive Smoldering Curative Approach Evaluating Novel Therapies And Transplant
Rochester, MN
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
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A Study To Evaluate Daratumumab/rHuPh20 +/- Lenalidomide As Post-ASCT Maintenance For Multiple Myeloma With Minimal Residual Disease (MRD) To Direct Therapy Duration
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.
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Open Nipple Sparing Mastectomy (NSM)
Rochester, MN
The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.
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Conventionally Fractionated Vs. Hypofractionated
Comprehensive Nodal Irradiation For Breast Cancer Using Pencil Beam Scanning ProtonTherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if the 2-year rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated pencil beam scanning proton therapy (PBS-PT) is non-inferior to conventionally-fractionated PBS-PT.
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A Consortium Trial To Evaluate Proton Vs. Photon Therapy For Patients With Non-metastatic Breast Cancer
Jacksonville, FL
The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.
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Pre-op Pembro + Radiation Therapy In Breast Cancer (P-RAD)
Rochester, MN
The purpose of this trilal is to study a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer.
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A Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of HPN217 In Patients With Relaped/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate HPN217 as monotherapy to assess the safety, tolerability and pharmacokinetics in patients with relapsed/ refractory multiple myeloma.
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Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy For Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the antitumor effectiveness and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and ...
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A Study Of Atezolizumab As Adjuvant Therapy In Participants With Renal Cell Carcinoma (RCC) At High Risk Of Developing Metastasis Following Nephrectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
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A Study To Evaluate Remote Monitoring In Cancer Care
Rochester, MN
The objectives of this study are to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, and to develop patient-specific algorithms to predict the trajectory of CRS and or neurotoxicity and time to escalation of medical intervention is needed.
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MC230813 A Study Of Golcadomide With Rituximab Prior To CAR-T With Relapsed Or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate efficacy as measured by the disease control rate (CMR, PMR, and NMR) by Lugano 2014 PET-CT based assessment after 2 cycles of therapy.
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Understanding The Relationship Between Benign Breast Tissue, Benign Breast Disease, And Breast Cancer Development
Jacksonville, FL
The purpose of this study is to culture human mammary cells to identify cellular characteristics associated with lobular involution status.
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Infection Outcomes Assessment of Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction
Rochester, MN
The purpose of this study is to demonstrate the safety and effectiveness of the Melodi Absorbable Antibacterial Matrix for soft tissue support in immediate, two-stage postmastectomy alloplastic prepectoral breast reconstruction, to support an FDA Premarket Approval (PMA) Application.
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A Study Of CART-TnMUC1 In Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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A Study To Evaluate Radiotherapy To The Whole Breast Or Post-mastectomy Chest Wall Including Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.
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A Study To Evaluate The Safety And Effectiveness Of ALLO-501A CAR T Cell Therapy In Adults With Relapsed/
Refractory Large B Cell Lymphoma
Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).
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Stereotactic Body Radiation Therapy With Immunotherapy For The Treatment Of Mesothelioma
Rochester, MN
The purpose of this study is to evaluate whether adding stereotactic body radiation therapy (SBRT) to immunotherapy as part of second line treatment for mesothelioma will improve the modest response rate of immunotherapy alone, provide local control/cytoreduction to sites of gross disease, and decrease symptomatic burden while improving outcomes.
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Open-label, Multi-center, Phase 1b/2 Clinical Trial To Evaluate The Safety And Efficacy Of Autologous CAR-BCMA T-cells (CT053) In Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.
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Study To Evaluate The Safety And Effectiveness Of Axicabtagene Ciloleucel In Combination With Utomilumab In Adults With Relapsed/Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward from Phase 1 into Phase 2, and to evaluate the effectiveness of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma in Phase 2.
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A Multi-Center Study Evaluating KTE-X19 In Pediatric And Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.
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Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Rochester, MN
There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women ...
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Evaluating Mepitel In Post-mastectomy Patients And The Role Of The Skin Microbiome In Radiation Dermatitis
Eau Claire, WI; Rochester, MN
The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. The goal is to improve understanding of the mechanism of radiation dermatitis.
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A Study Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
Rochester, MN
The purpose of this study is to evaluate patient outcomes after undergoing 68Ga-PSMA PET/CT imaging prior to initiation of immunotherapy to identify PSMA PET/CT positive patients (estimated N=20) for long term follow up.
In adult patients with advanced, pathologically confirmed HCC who are not amenable to curative restriction, transplantation or ablative therapies, and have radiographically measurable disease by RECIST; eligible for atezolizumab/bevacizumab front line therapy.
- Specific Aim 1. To test the performance of novel biomarkers derived from PSMA PET/CT to measure response compared to RECIST criteria, in advanced HCC patients treated with immunotherapy.
- Specific Aim 2. To identify precision ...
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A Study To Evaluate Yttrium-90 Therapy For Radiation Lobectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The Patient Group 1 primary objective is to measure the distribution of 90Y glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day postradioembolization study-specific non-FDG PET/CT scan. Correlate this measurement with mean lobar absorbed radiation dose and embolic load given to patients and time taken to achieve adequate Future Liver Remnant (> 40% of total liver volume) to determine if there is an optimal lobar dose and embolic load.
The Patient Group 2 primary objectives are to assess the association of circulating and imaging biomarkers on Future Liver Remnant hypertrophy, and to assess progression-free survival between ...
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Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
Rochester, MN; Jacksonville, FL
This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.
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First In Human (FIH) Study Of REGN5459 In Patients With Relapsed Or Refractory Multiple Myeloma (MM)
Rochester, MN
The purpose of this study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) (defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR]) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.
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A Study To Compare Tisagenlecleucel Vs. Standard Of Care In Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
Jacksonville, FL
This is a randomized, open label, multicenter phase III trial to determine the efficacy and safety of tisagenlecleucel treatment strategy in adult patients with relapsed or refractory aggressive B-cell NHL after failure of rituximab and anthracycline containing frontline immunochemotherapy.
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Claudin18.2 CAR-T (CT041) In Patients With Gastric, Pancreatic Cancer, Or Other Specified Digestive Cancers
Rochester, MN
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.
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A Phase 1-2 Multi-Center Study Evaluating Axicabtagene Ciloleucel In Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).
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Inherited Breast Cancer Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to improve the interpretation of mutations in breast cancer predisposition genes. This will be accomplished by recruiting members of families found to carry deleterious (mainly protein truncating) mutations and evaluating co-segregation of the mutations with cancer within families.
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Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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A Study To Develop And Validate Hybrid Molecular Imaging To Transform The Care Of Hepatocellular Carcinoma Patients
Rochester, MN
The primary purpose of this study is to evaluate diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) PET/MRI OR PET/CT for HCC using surgical histopathology (either resection, transplant or biopsy specimens) or LI-RADS® categorization as gold standard.
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Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.
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A Study To Evaluate CTX110 In Subjects With Relapsed Or Refractory B-Cell Malignancies
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness CTX110 in subjects with relapsed or refractory B cell malignancies.
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Safety And Efficacy Of Bb2121 (Ide-cel) Combinations In Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the safety and effectiveness of bb2121 (Ide-Cel) combinations in subjects with relapsed/refractory multiple myeloma. It also aims to evaluate different agents and their doses/schedules to improve clinical effectiveness in combination with bb2121.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
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Testing Whether Treating Breast Cancer Metastases With Surgery Or High-Dose Radiation Improves Survival
Jacksonville, FL; Rochester, MN
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic ...
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Experiences of Acupuncture among Breast Cancer Survivors
Rochester, MN
The purpose of this study is to determine the feasibility and perceived effectiveness of acupuncture for breast cancer-related symptoms.
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Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and ...
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A Study to Evaluate the Safety of the Goldilocks Procedure with Implant-Based Reconstruction
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
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ROR1771: A Prospective Observational Study Of Proton Stereotactic Body Radiation Therapy And Immunotherapy For Recurrent/Progressive Locoregional Or Metastatic Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
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Rituximab With Or Without Stem Cell Transplant In Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma In First Complete Remission
Jacksonville, FL; Rochester, MN
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. ...
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Blood-Brain Barrier Disruption (BBBD) For Liquid Biopsy In Subjects With GlioBlastoma Brain Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of using Exablate Model 4000 Type-2.0/2.1 in adults with Glioblastoma brain tumors to increase temporarily the permeability of the blood brain barrier, allowing increased passage of circulating free DNA (cfDNA) for sampling and analysis.
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Testing Whether High Dose Chemotherapy And Infusion Of The Patients' Own Stem Cells Improves Survival In Patients With Peripheral T-cell Lymphoma Who Achieved A Complete Response At The End Of The Initial Chemotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior ...
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A Study To Evaluate Cancer Distress, Psychological Trauma, And Resiliency In Hospitalized Hematopoietic Stem Cell Transplant Patients
Jacksonville, FL
The purpose of this study is to better understand the distress experience of hospitalized patients undergoing hematopoietic stem cell transplant (HSCT), and to examine the relationship between cancer distress, psychological trauma, and resiliency over time.
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Cerebrospinal Fluid Biomarkers For Brain Tumors
Rochester, MN
The purpose of this study is to help generate a repository of Cerebrospinal Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.
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Ommaya At Biopsy
Rochester, MN
The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.
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ROR1771: A Prospective Observational Study Of Proton Stereotactic Body Radiation Therapy And Immunotherapy For Recurrent/Progressive Locoregional Or Metastatic Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
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A Study to Collect Adipose Harvest for Mesenchymal Stem Cell Derivation in Patients with Head & Neck Cancer
Rochester, MN
The purpose of this study is to collect adiopose tissue to derive mesenchymal stem cells.
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A Study to Evaluate Software On Cross-sectional Imaging Evaluation of Microwave-ablated Liver Tumors
Rochester, MN
The primary purpose of this study is to assess the accuracy of the Philips High Precision 3D Ablation Solution software on cross-sectional imaging evaluation of microwave-ablated liver tumors, and to determine whether software accuracy varies based on patient, tumor, and technical procedural factors.
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Dose-Escalated Photon IMRT Or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy And Temozolomide In Treating Patients With Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...
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A Registry For Children Treated With Proton Radiation Therapy
Rochester, MN
The purpose of the Pediatric Proton Consortium Registry (PPCR) is to enroll children who have been treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data which many centers that deliver proton radiation therapy already collect in routine operations.
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Short Course Radiotherapy For The Treatment Of Patients With Glioblastoma, SAGA Study
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Scottsdale/Phoenix, AZ
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.
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A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.
Scottsdale/Phoenix, AZ
This study aims to assess the utility of pharyngeal manometry measures as a novel approach in quantifying internal lymphedema and compare success rates in reducing internal lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). It also aims to assess efficacy of PCD and MLD and assess compliance of treatment in both groups. Lastly, it aims to identify voice and swallowing changes in both groups.
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Proton Or Photon RT For Retroperitoneal Sarcomas
Rochester, MN
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.
Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, ...
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Comparison Of Acute Toxicities Between Patients Treated With Protons Or Intensity Modulated Radiation Therapy After Surgery For The Treatment Of Endometrial Or Cervical Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).
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A Study Of Proton Versus Photon Beam Radiotherapy In The Treatment Of Unilateral Head And Neck Cancer
Rochester, MN
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
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A Study To Investigate LYL797 In Adults With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.
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Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the ...
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18F-DOPA PET In Sarcoma Patients
Jacksonville, FL
The purpose of this study is to identify early response biomarkers from biological or functional imaging to better align with clinical trial endpoints and minimize sarcoma patient toxicities.
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International Registry For Men With Advanced Prostate Cancer (IRONMAN)
Jacksonville, FL
The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.
The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.
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Positron Emission Tomography Using 64Cu-SAR-bisPSMA In Participants With High-risk Prostate Cancer Prior To Radical Prostatectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
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A Study To Evaluate The Feasibility Of Intraoperative Microdialysis (Tissue Sampling) During Neurosurgery For Central Nervous System Malignancies
Rochester, MN
Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
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3D Ultrasound For The Imaging Of Axillary Lymph Nodes In Patients With Breast Cancer
Rochester, MN
The overall goal of this project is to study a new 3D ultrasound imaging technology for evaluation of axillary lymph nodes in patients with breast cancer.
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Dinutuximab With Chemotherapy, Surgery And Stem Cell Transplantation For The Treatment Of Children With Newly Diagnosed High Risk Neuroblastoma
Rochester, MN
The purpose of this stduy tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing ...
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Study Of Rezafungin Compared To Standard Antimicrobial Regimen For Prevention Of Invasive Fungal Diseases In Adults Undergoing Allogeneic Blood And Marrow Transplantation (ReSPECT)
Rochester, MN
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).
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An Extension Study MRI/US Fusion Imaging And Biopsy In Combination With Nanoparticle Directed Focal Therapy For Ablation Of Prostate Tissue
Rochester, MN
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
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Intrapatient Comparison Of Urinary Radioactivity Following Piflufolastat (18F) And Flotufolastat (18F) PET In Men With Low PSA Biochemical Recurrence Of Prostate Cancer Following Radical Prostatectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
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Patient Outcomes After Hepatic Artery Infusion Pump Placement
Rochester, MN
The purpose of this study is to evaluate the short-term outcomes and the quality of life (QOL) after cholecystectomy and hepatic artery infusion pump placement for localized unresectable colorectal liver metastases (CRLM).
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Safe Omission Of Pelvic Lymph Node Dissection During Radical Prostatectomy
Jacksonville, FL
This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.
Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, common iliac, obturator packet, ...
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A Study Comparing Proton And Photon Radiation Outcomes In Prostate Cancer Patients
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine if prostate cancer patients treated with proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).
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A Study To Compare Proton Therapy To Photon Radiation Therapy For Esophageal Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in ...
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Pre-operative Vs. Post-operative Radiosurgery For Metastatic Brain Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
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A Study To Evaluate The Role Of Gut Microbiome In Cancer Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to correlate gut microbiome with specific cancer diagnoses and the clinical response (effectiveness), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.
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The NeoGlioma Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.
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A Study to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy
Rochester, MN
The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods.
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SPORT-DMG
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of hypofractionation with planned courses of re-irradiation for patients with diffuse midline gliomas of the pons.
Subjects will be screened by neurosurgery, radiation oncology, or pediatric oncology at outpatient clinic or by the multidisciplinary pediatric central nervous system tumor conference. Interested qualified patients and their families will be consented and offered participation in this study
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A Study to Evaluate Early Detection of SARS-CoV-2/COVID-19 in High Risk Radiation Oncology Patients
Rochester, MN
The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients who ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.
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A Study to Evaluate Same Day Discharge Post-mastectomy with/without Alloplastic Breast Reconstruction
Rochester, MN
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.
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A Study Of Daratumumab, Bortezomib, Lenalidomide And Dexamethasone (DVRd) Followed By Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide And Dexamethasone (DVRd) Followed By Autologous Stem Cell Transplant (ASCT) In Participants With Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
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A Study To Determine The Effects Of COVID-19 In Cancer Patients
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.
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A Study to Test Concussion Return to Baseline after Elective Craniotomy Procedure
Jacksonville, FL
The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.