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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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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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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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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 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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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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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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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 Of Tucatinib With Trastuzumab And MFOLFOX6 Versus Standard Of Care Treatment In First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. 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 in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
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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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Symbiotic-GI-03: A Study To Learn About The Study Medicine Called PF-08634404 In Combination With Chemotherapy In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have colorectal cancer that has spread to other parts of your body.
* Be in good enough health to receive study treatment.
* Should not be ...
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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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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 Study Evaluating The Safety And Efficacy Of Targeted Therapies In Subpopulations Of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
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A Study in Second Line Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the overall survival with ramucirumab combined with FOLFIRI or a placebo and FOLFIRI in patients who have metastatic colorectal cancer.
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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 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 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 To Evaluate MM-151, Nal-IRI, 5-FU, And Leucovorin For RAS/RAF Wild-Type Metastatic Colorectal Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.
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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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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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A Study of the Quality of Life of Patients who have Hereditary Nonpolyposis Colorectal Cancer
Rochester, MN
The purpose of this study is to show the quality of life and bowel function in patients who have been diagnosed with rectal cancer and are known to have Hereditary Nonpolyposis Colorectal Cancer (HNPCC), especially to make comparisons between clinical managements, family history, and health behaviors.
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Collecting Blood And Stool Samples To Detect Colorectal Cancer Or Advanced Neoplasia In Lynch Syndrome Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.
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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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Study Of SAR444881 Administered Alone And In Combination With Other Therapeutics In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with ...
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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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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 Safety And Efficacy Of A2B395, An Allogeneic Logic-gated CAR T, In Participants With Solid Tumors That Express EGFR And Have Lost HLA-A*02 Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy ...
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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.