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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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Testing Olaparib For One Or Two Years, With Or Without Bevacizumab, To Treat Ovarian Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5\'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib ...
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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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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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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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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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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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A Study To Learn About How Women Metabolize And Respond To Opioids When Used For Managing Post-operative Pain
Rochester, MN
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for surgical ovarian cancer patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of opioid medications.
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Broad Evidence Of Systemic Immune Activation In Long Term Survivors Of Advanced Ovarian Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if long-term ovarian cancer survivors after receipt of a vaccine targeting folate receptor alpha will have persistent T cell and antibody responses to folate receptor alpha and will have broad evidence of systemic immune activation.
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Improving Genetic Referral Rates in Women with Ovarian Cancer
Rochester, MN
The purpose of this study is to determine if the implementation of a genetic referral toolkit increases the genetic referral rates for women with epithelial ovarian cancer at Mayo Clinic Rochester and to determine barriers to genetics counseling and testing from a patient perspective
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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 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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Patient Experience And Understanding Of Genetic Testing In Ovarian Cancer
Rochester, MN
The purpose of this study is to investigate the experience and understanding of patients with ovarian cancer in relation to genetic testing by means of one-on-one qualitative interviews and survey.
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A Study To Compare Two Surgical Procedures In Women With BRCA1 Mutations To Assess Reduced Risk Of Ovarian Cancer
Rochester, MN
This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
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Metabolite Levels In Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors
Rochester, MN
The purpose of this study is to determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.
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FrαDcs Or Placebo For Patients With Advanced Stage Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether vaccination with folate receptor alpha dendritic cells (FRalphaDCs) given to patients with advanced ovarian, fallopian tube, or primary peritoneal cancer can delay or prevent cancer recurrence, when compared with a placebo. FRalphaDCs are a vaccine made from patients' white blood cells that have been cultured in the laboratory to induce immune responses to the cancer.
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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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ADVANCE 2: ADdressing Views Of African AmericaNs On CancEr Screening
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this research study is to understand the views and experiences of Non-Hispanic Black women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk and research participation.
This is a qualitative interview study. Study participation involved talking on the phone or videoconference (e.g., Zoom) for about 1 - 1 1/2 hours with a researcher.
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ADVANCE
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this research study is to understand the views and experiences of African American women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk.
This is a qualitative interview study. Study participation involves talking on the phone or videoconference (e.g., Zoom) for about 1 hour with a researcher.
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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 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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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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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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Testing The Addition Of Abemaciclib To Olaparib For Women With Recurrent Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them ...
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Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers
Rochester, MN
The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy
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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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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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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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Chemotherapy Toxicity On Quality of Life in Older Patients with Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.
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A Study To Evaluate Regulation Of The Metabolism Of T-Cells By The Tumor Microenvironment In Ovarian Cancer Metastasis
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze how the immune cell repertoire changes during early and late metastasis which could shed light into how the tumor microenvironment in metastatic disease becomes tumor permissive.
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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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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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Veliparib And Topotecan Hydrochloride In Treating Patients With Solid Tumors, Relapsed Or Refractory Ovarian Cancer, Or Primary Peritoneal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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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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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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Pembrolizumab In Treating Participants With Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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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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Pembrolizumab With Chemotherapy And With/Without MK-4830 For Treating Participants With Ovarian Cancer
Jacksonville, FL
The purpose of this study is to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + Standard of Care (SOC) therapy.
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Study Of Carboplatin And Mirvetuximab Soravtansine In First-Line Treatment Of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube Or Primary Peritoneal Cancer
Rochester, MN
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive ...
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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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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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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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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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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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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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MV-NIS Or Investigator's Choice Chemotherapy In Treating Patients With Ovarian, Fallopian, Or Peritoneal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
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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 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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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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Heated Intraperitoneal Chemotherapy Followed By Niraparib For Ovarian, Primary Peritoneal And Fallopian Tube Cancer (HOTT)
Rochester, MN
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC ...
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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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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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Establishment Of Preclinical Models From Patients With Gynecological Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
Effective treatments for recurrent gynecological cancer are lacking, and there is a need for novel therapeutic options. One of the barriers to improving outcomes in this subgroup of patients is the paucity of tumor models that can mimic patient characteristics to study novel therapies. Patient-derived xenograft (PDX) models are considerate the most representative pre-clinical model of human cancer, recapitulating the key characteristics of the original patient tumor. Other preclincal models to test drug effcicacy includes ex vivo 3D culture and 2D culture systems. In this study, we make and test preclinical models of gynecological cancers (ovarian, fallopian tube, peritoneal, uterine, ...
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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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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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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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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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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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A Phase 1 In Patients With HLA-A*0201+ And WT1+ Recurrent/Metastatic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
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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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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 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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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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Highly Selective CDK7 Inhibitor Q901 In Selected Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.
The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, ...
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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 Of PY314 In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
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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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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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A Study To Evaluate Precision Pharmacogenomics In Cancer Patients
Scottsdale/Phoenix, AZ
THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.
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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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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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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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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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A Study To Develop A Biorepository Of Blood Samples From Cancer Patients Participating In The Gemini (IRB 19-006717) Protocol
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to develop a biorepository of blood samples from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies.
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An Investigational Immuno-therapy Study To Assess The Safety, Tolerability And Effectiveness Of Anti-LAG-3 With And Without Anti-PD-1 In The Treatment Of Solid Tumors
Rochester, MN
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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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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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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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.
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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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CfDNA Assay Prospective Observational Validation For Early Cancer Detection And Minimal Residual Disease (CAMPERR)
Rochester, MN
The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.
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Study Of E7386 In Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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Understanding The Challenges, Behavioral Patterns, And Preferences Towards Participation In Clinical Trials In Minority Patient Populations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.
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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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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.