NCT07523763

Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer

Phase II Open-label Non-randomized Study of Neoadjuvant Low-dose Immunotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair Deficiency (dMMR)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.

Detailed description

Patients with clinical high risk stage II (T3 with extramural extension ≥ 5mm or T4), stage III dMMR/MSI CRC will be treated with low-dose immunotherapy: nivolumab 100 mg every 2 weeks or pembrolizumab 100 mg every 4 weeks, then will be underwent surgery after 6 months of immunotherapy. Pts who refuse surgery and/or in case of complete clinical response (cCR) will continue therapy up to 1 year.

Conditions

• Colorectal Cancer (MSI-H)
• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 100 mg infusion
DRUG	Pembrolizumab	Pembrolizumab 100 mg infusion

Timeline

• Start date: 2024-03-22
• Primary completion: 2025-12-31
• Completion: 2027-03-31
• First posted: 2026-04-13
• Last updated: 2026-04-17

Locations

1 site across 1 country: Russia