60
Participants
Start Date
September 30, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2029
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).
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."
Surgery
Standard of care surgery performed with a maximal delay of 21 days (3 weeks) from randomization.
Adjuvant chemotherapy
Adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) according to the current guidelines, at the investigator's discretion.
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
Fondation ARCAD
OTHER
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER