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NCT04126733 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Colorectal Cancer, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 15
- Study locations
NCT04126733: Completed Phase 2 study of Colorectal Cancer, sponsored by Bayer.
NCT04126733 is a Phase 2 study of Colorectal Cancer that has completed, run by Bayer. The registered enrollment target is 70 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04126733, a Phase 2 study of Colorectal Cancer, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
ORR was defined as the percentage of participants with overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
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 |
What the finished NCT04126733 record still lists
NCT04126733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower).
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.
NCT04126733 lists 15 locations in 12 states (Texas, California, Colorado).
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.
What interventions are being tested in trial NCT04126733?
The interventions under investigation include: Regorafenib (Stivarga, BAY73-4506) (DRUG), Nivolumab (Opdivo) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04126733?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04126733's enrollment target sits among peer trials
70 244th of 381 higher than 134 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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