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

NCT06646445 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-13

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Pembrolizumab Injection [Keytruda]

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).

PROCEDURE

Watch-and-wait approach

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.

PROCEDURE

Surgery

Standard of care surgery performed with a maximal delay of 21 days (3 weeks) from randomization.

DRUG

Adjuvant chemotherapy

Adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) according to the current guidelines, at the investigator's discretion.

Sponsors & Collaborators

  • Fondation ARCAD

    collaborator OTHER

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646445 on ClinicalTrials.gov