A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer (NCT05723562)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (42 Sites)
Showing the first 25 of 42 sites.
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Albuquerque, New Mexico
- GSK Investigational Site — New York, New York
- GSK Investigational Site — Pittsburgh, Pennsylvania
- GSK Investigational Site — Nashville, Tennessee
- GSK Investigational Site — Dallas, Texas
- GSK Investigational Site — Richmond, Virginia
- GSK Investigational Site — Ottawa, Ontario
- GSK Investigational Site — Toronto, Ontario
- GSK Investigational Site — Montreal, Quebec
- GSK Investigational Site — Sherbrooke, Quebec
- GSK Investigational Site — Besançon,
- GSK Investigational Site — Marseille,
- GSK Investigational Site — Paris,
- GSK Investigational Site — Pessac,
- GSK Investigational Site — Rennes,
- GSK Investigational Site — Berlin,
- GSK Investigational Site — Dresden,
- GSK Investigational Site — Düsseldorf,
- GSK Investigational Site — Frankfurt,
- GSK Investigational Site — München,
- GSK Investigational Site — Milan,
- GSK Investigational Site — Padova,
- GSK Investigational Site — Roma,
- GSK Investigational Site — Chiba,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Neoplasms, Rectal clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.