NCT07269249

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1). Secondary objectives are: 1. To describe the activity of neoadjuvant dostarlimab in terms of: * complete clinical response rate at 6 and 12 months * time to clinical complete response * duration of clinical complete response * near-complete clinical response rate at 6 and 12 months * duration of near-complete clinical response * duration of objective response * rate of surgery (total mesorectal excision or local excision) * pathological complete response rate * objective response rate (RECIST 1.1) assessed by central radiological review. 2. To describe the safety of neoadjuvant dostarlimab in terms of: Adverse events/SAE incidence and outcome, time and duration of toxicity according to CTCAE v5.0. 3. To descrive the efficacy of neoadjuvant dostarlimab in terms of: event free-survival (EFS), organ preservation at 3 years, time to ditance recurrence and overall survival (OS)

Conditions

• Locally Advanced Rectal Cancer (LARC)

Interventions

Type	Name	Description
DRUG	Dostarlimab	Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

2 sites across 1 country: Italy