Trial Condition(s):

Colorectal Cancer

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)

Bayer Identifier:

20975

ClinicalTrials.gov Identifier:

NCT04126733

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
70
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Regorafenib+Nivolumab
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

City of Hope National Medical Center

Duarte, United States, 91010

Status
Completed
 
Locations

Minnesota Oncology Hematology, PA

Minneapolis, United States, 55404

Status
Completed
 
Locations

Sarah Cannon Cancer Center

Nashville, United States, 37203

Status
Completed
 
Locations

New York Oncology Hematology. P.C.

Albany, United States, 12206

Status
Completed
 
Locations

Northwest Cancer Specialists, PC

Vancouver, United States, 98684

Status
Completed
 
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Completed
 
Locations

Rocky Mountain Cancer Centers

Denver, United States, 80218

Status
Completed
 
Locations

Illinois Cancer Specialists

Arlington Heights, United States, 60005

Status
Completed
 
Locations

Virginia Oncology Associates

Newport News, United States, 23606

Status
Completed
 
Locations

Texas Oncology-Arlington North

Arlington, United States, 76012

Status
Completed
 
Locations

Nebraska Cancer Specialists

Papillion, United States, 68046

Status
Completed
 
Locations

Willamette Valley Cancer Institute and Research Center

Eugene, United States, 97401

Status
Completed
 
Locations

Miami Cancer Institute at Baptist Health South Florida

Miami, United States, 33176

Status
Completed
 
Locations

Baylor Charles A. Sammons Cancer Center at Dallas

Dallas, United States, 75246

Status
Completed
 
Locations

Texas Oncology-Sherman

Sherman, United States, 75090

Status
Completed
 

Trial Design