Trials / Active Not Recruiting
Active Not RecruitingNCT05723562
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dostarlimab | Dostarlimab will be administered. |
Timeline
- Start date
- 2023-04-03
- Primary completion
- 2026-11-02
- Completion
- 2029-10-11
- First posted
- 2023-02-10
- Last updated
- 2026-01-08
Locations
42 sites across 10 countries: United States, Canada, France, Germany, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05723562. Inclusion in this directory is not an endorsement.