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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)/Microsatellite Stable (MSS) Colorectal Cancer (CRC)

NCT04126733•Bayer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (15)

City of Hope National Medical Center

Duarte, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, United States

Nebraska Cancer Specialists

Papillion, Nebraska, United States

New York Oncology Hematology. P.C.

Albany, New York, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Texas Oncology-Arlington North

Arlington, Texas, United States

Key Dates

Start Date

October 14, 2019

Primary Completion Date

November 11, 2020

Completion Date

March 28, 2022

Last Updated

July 18, 2023

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Regorafenib (Stivarga, BAY73-4506)

DRUG

Nivolumab (Opdivo)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors