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

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT07523763
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 100 mg infusion
  • Pembrolizumab — DRUG
    Pembrolizumab 100 mg infusion

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Mar 22, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2025
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    The patients will be treated with nivolumab 100 mg every 2 weeks during 6 months until surgery
  • Experimental: Pembrolizumab
    The patients will be treated with pembrolizumab 100 mg every 4 weeks during 6 months until surgery

Primary Outcome Measure

Complete response (pathological complete response - pCR + durable clinical complete response - cCR) [ Time Frame: up to 8 months ]

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