Trials / Recruiting
RecruitingNCT05855200
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 892 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dostarlimab | Dostarlimab will be administered. |
| DRUG | CAPEOX | CAPEOX will be administered. |
| DRUG | FOLFOX | FOLFOX will be administered. |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2029-03-19
- Completion
- 2031-03-27
- First posted
- 2023-05-11
- Last updated
- 2026-01-23
Locations
266 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Estonia, Finland, France, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, Norway, Panama, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05855200. Inclusion in this directory is not an endorsement.