Trials / Completed
CompletedNCT03712943
Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer
Phase I Study of Regorafenib and Nivolumab in Mismatch Repair (MMR) Proficient Advanced Refractory Colorectal Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to test the safety, tolerable side effects, and determine the highest tolerable dose of the combination of Regorafenib and Nivolumab. Researchers want to find out if this combination of Regorafenib and Nivolumab can help people with metastatic colorectal cancer with mismatch repair (MMR) proficiency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regorafenib | Regorafenib orally 80 mg daily for 21 days (3 weeks on, 1 week off). |
| DRUG | Nivolumab | Nivolumab 240 mg administered intravenously every 2 weeks. |
Timeline
- Start date
- 2018-10-23
- Primary completion
- 2021-09-01
- Completion
- 2024-01-18
- First posted
- 2018-10-19
- Last updated
- 2026-02-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03712943. Inclusion in this directory is not an endorsement.