Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT07269249
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Cancer (LARC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Study Details

This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR/MSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.

Key Dates

Start date
Sep 1, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Stage II-III rectal cancer (LARC)
    patients with dMMR/MSI LARC treated with neoadjuvant dostarlimab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months ]

Central Contacts

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