A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT06640049
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Neoplasms, Rectal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dostarlimab — BIOLOGICALDostarlimab will be administered.
Study Details
The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.
Key Dates
- Start date
- Oct 17, 2024
- Status verified
- Nov 2025
- Primary completion
- Oct 24, 2027
- Completion
- Apr 15, 2031
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dostarlimab monotherapyParticipants will receive dostarlimab as monotherapy.
Primary Outcome Measure
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) [ Time Frame: 18 months ]