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)
Public ClinicalTrials.gov record NCT04126733. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04126733
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Interventions
- Regorafenib (Stivarga, BAY73-4506) Drug
- Nivolumab (Opdivo) Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 13, 2019
- Primary completion
- Nov 10, 2020
- Completion
- Mar 27, 2022
- Last update posted
- Jul 17, 2023
2019 – 2022
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Miami Cancer Institute at Baptist Health South Florida | Miami | Florida | 33176 | — |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | — |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | — |
| Nebraska Cancer Specialists | Papillion | Nebraska | 68046 | — |
| New York Oncology Hematology. P.C. | Albany | New York | 12206 | — |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | — |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Arlington North | Arlington | Texas | 76012 | — |
| Baylor Charles A. Sammons Cancer Center at Dallas | Dallas | Texas | 75246 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology-Sherman | Sherman | Texas | 75090 | — |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | — |
| Northwest Cancer Specialists, PC | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04126733, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04126733 live on ClinicalTrials.gov.