drugset / Trial / NCT05723562

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

NCT05723562

Phase 2 Active not recruiting 154 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-04-03
Primary completion
2026-11-02
Completion
2029-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Dostarlimab Monoclonal antibody

Indications