Colon Cancer Clinical Trial

Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

Summary

The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells.

Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histological or cytological confirmed advanced, metastatic, or progressive pMMR/MSS adenocarcinoma of colon or rectum
Participant must have progressed or be intolerant to prior systemic chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy. Exceptions may apply
Participants must have adequate organ and marrow function defined by protocol-specified laboratory tests
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1
Provision of recently obtained tumor tissue as per protocol specified requirement
Anticipated life expectancy greater than 3 months
Be able to swallow and absorb oral tablets

Exclusion Criteria:

Participants with Mismatch repair deficient (dMMR) / microsatellite instable-high (MSI-H) colorectal cancer
Prior therapy with regorafenib, anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer
Presence of active central nervous system (CNS) metastases; participants with stable CNS disease or previously treated lesions are eligible for study entry
Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 mmHg despite optimal medical management
Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen
Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication
Participants with an active, known or suspected autoimmune disease
History of interstitial lung disease or pneumonitis
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection
Other protocol defined inclusion/exclusion criteria could apply

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT04126733

Recruitment Status:

Completed

Sponsor:

Bayer

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There are 15 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
Miami Cancer Institute at Baptist Health South Florida
Miami Florida, 33176, United States
Illinois Cancer Specialists
Arlington Heights Illinois, 60005, United States
Minnesota Oncology Hematology, PA
Minneapolis Minnesota, 55404, United States
Nebraska Cancer Specialists
Papillion Nebraska, 68046, United States
New York Oncology Hematology. P.C.
Albany New York, 12206, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States
Texas Oncology-Arlington North
Arlington Texas, 76012, United States
Baylor Charles A. Sammons Cancer Center at Dallas
Dallas Texas, 75246, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology-Sherman
Sherman Texas, 75090, United States
Virginia Oncology Associates
Newport News Virginia, 23606, United States
Northwest Cancer Specialists, PC
Vancouver Washington, 98684, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT04126733

Recruitment Status:

Completed

Sponsor:


Bayer

How clear is this clinincal trial information?

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