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

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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