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

Conditions

• Neoplasms, Rectal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dostarlimab — BIOLOGICAL
  Dostarlimab will be administered.

Study Details

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.

Key Dates

Start date

Apr 3, 2023

Status verified

May 2026

Primary completion

Nov 2, 2026

Completion

Oct 11, 2029

Study Design

Enrollment

154 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dostarlimab monotherapy

Primary Outcome Measure

Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) [ Time Frame: 18 Months ]

Locations (7)

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