Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT06646445
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab Injection [Keytruda] — DRUG
    Pembrolizumab 200 mg via a 30-minute IV infusion q3w on Day 1 of each 21-day cycle; 8 cycles ± 9 additional cycles (17 cycles in total).
  • Watch-and-wait approach — PROCEDURE
    Watch-and-wait strategy: * TAP-CT scan At months 3 and 6 during 8 cycles of treatment, at months 9 and 12, and during additional 9 cycles of treatment if performed, and every 3 months thereafter for up to 2 years, * Colonoscopy with biopsies at months 3, 6, 9, 12, and 24.
  • Surgery — PROCEDURE
    Standard of care surgery performed with a maximal delay of 21 days (3 weeks) from randomization.
  • Adjuvant chemotherapy — DRUG
    Adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) according to the current guidelines, at the investigator's discretion.

Study Details

The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR/MSI-H localized CRC when treated with neoadjuvant pembrolizumab. Eligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection ± adjuvant chemotherapy (arm B).

Key Dates

First listed
Oct 17, 2024
Start date
Sep 30, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm A (Pembrolizumab plus watch-and-wait approach)
    Pembrolizumab and Watch-and-wait (TAP-CT scan, colonoscopy with biopsies)
  • Active Comparator: Arm B (Surgical resection ± adjuvant chemotherapy)
    Standard of care surgery ± adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months)

Primary Outcome Measure

The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization. [ Time Frame: 6 months ]

Central Contacts

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