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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions
Colon Cancer
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.

Trial Locations (10)

Unknown

Institut Sainte Catherine, Avignon

CHU Besançon, Besançon

IHFB Cognacq Jay, Levallois-Perret

Centre Leon Berard, Lyon

Groupe Hospitalier Diaconesses Croix Saint Simon, Paris

Hôpital Saint Antoine, Paris

Institut Mutualiste Montsouris, Paris

CHU Bordeaux Haut Lévêque, Pessac

CHU Poitiers, Poitiers

CHU Toulouse, Toulouse

All Listed Sponsors
collaborator

Fondation ARCAD

OTHER

lead

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER