A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Dostarlimab: Dostarlimab will be administered.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) — 18 Months
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 12 months following their post-intervention disease assessment (PIDA)
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | France | |
| GSK Investigational Site | Marseille | France | |
| GSK Investigational Site | Paris | France | |
| GSK Investigational Site | Pessac | France | |
| GSK Investigational Site | Rennes | France | |
| GSK Investigational Site | Berlin | Germany | |
| GSK Investigational Site | Dresden | Germany | |
| GSK Investigational Site | Düsseldorf | Germany | |
| GSK Investigational Site | Frankfurt | Germany | |
| GSK Investigational Site | München | Germany | |
| GSK Investigational Site | Milan | Italy | |
| GSK Investigational Site | Padova | Italy | |
| GSK Investigational Site | Roma | Italy | |
| GSK Investigational Site | Chiba | Japan | |
| GSK Investigational Site | Kanagawa | Japan | |
| GSK Investigational Site | Osaka | Japan | |
| GSK Investigational Site | Osaka | Japan | |
| GSK Investigational Site | Utrecht | Netherlands | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Barcelona | Spain | |
| GSK Investigational Site | Granada | Spain | |
| GSK Investigational Site | Madrid | Spain | |
| GSK Investigational Site | Madrid | Spain | |
| GSK Investigational Site | Santander | Spain | |
| GSK Investigational Site | Valencia | Spain | |
| GSK Investigational Site | Leeds West Yorkshire | United Kingdom |
+ 2 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05723562 on ClinicalTrials.gov ↗ ← All trials in the UK