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

Status
Active
Cancer Type
Colon/Rectal Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05723562
Protocol IDs
219369 (primary)
NCI-2023-04062
2022-003289-18
Study Sponsor
GlaxoSmithKline

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

  1. Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer
  2. Participant has radiologically and endoscopically evaluable disease.
  3. Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.