Medical Information Only. Always consult your healthcare provider before enrolling in any 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)
NCT04126733 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Regorafenib (Stivarga, BAY73-4506)
- BIOLOGICAL Nivolumab (Opdivo)
Study Locations (15)
Texas
- Texas Oncology-Arlington North — Arlington
- Baylor Charles A. Sammons Cancer Center at Dallas — Dallas
- University of Texas MD Anderson Cancer Center — Houston
- Texas Oncology-Sherman — Sherman
California
- City of Hope National Medical Center — Duarte
Colorado
- Rocky Mountain Cancer Centers — Denver
Florida
- Miami Cancer Institute at Baptist Health South Florida — Miami
Illinois
- Illinois Cancer Specialists — Arlington Heights
Minnesota
- Minnesota Oncology Hematology, PA — Minneapolis
Nebraska
- Nebraska Cancer Specialists — Papillion
New York
- New York Oncology Hematology. P.C. — Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2022-03-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04126733
The ClinicalTrials.gov registry entry for NCT04126733 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which Regorafenib (Stivarga, BAY73-4506) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04126733 reports 15 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04126733 about?
NCT04126733 is a clinical study titled "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)". 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 i...
What is the current status of trial NCT04126733?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2019-10-14. Estimated completion is 2022-03-28.
What conditions does trial NCT04126733 study?
This clinical trial studies the following conditions: Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04126733?
The interventions under investigation include: Regorafenib (Stivarga, BAY73-4506) (DRUG), Nivolumab (Opdivo) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04126733?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04126733 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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