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NCT03800602 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT03800602: Completed Phase 2 study, sponsored by Emory University.
NCT03800602 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03800602, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This phase II trial studies how well nivolumab and metformin work in treating patients with microsatellite stable (MSS) stage IV colorectal cancer that has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Metformin is an antidiabetic drug that and may reduce the risk of colorectal cancer development in patients. Giving nivolumab and metformin may work better in treating patients with refractory microsatellite metastatic colorectal cancer.
Primary Outcome
Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1., and rate will be calculated as a proportion (responders/total patients).
Interventions
- DRUG Metformin
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2021-09-04 |
| Phase | Phase 2 |
What the finished NCT03800602 record still lists
NCT03800602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT03800602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03800602 about?
NCT03800602 is a clinical study titled "Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer". This phase II trial studies how well nivolumab and metformin work in treating patients with microsatellite stable (MSS) stage IV colorectal cancer that has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the c...
What is the current status of trial NCT03800602?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2019-01-15. Estimated completion is 2021-09-04.
What interventions are being tested in trial NCT03800602?
The interventions under investigation include: Metformin (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03800602?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03800602's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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