Immunotherapy in Patients With Early dMMR Rectal Cancer

The purpose of this investigator-initiated, multicenter phase II trial is to evaluate the efficacy and tolerability of nivolumab and ipilimumab in patients with stage 1-3 MSI/dMMR rectal cancer. The primary objective is: Number of patients with complete clinical response after one or two cycles of immunotherapy. Patients will be treated with 1 or 2 cycles of combination immunotherapy: Cycle 1: Nivolumab 3 mg/kg days 1 and 15 \& ipilimumab 1 mg/kg day 1 Cycle 2: Nivolumab 3 mg/kg days 50 and 65 \& ipilimumab 1 mg/kg day 50

NCT Number	NCT05732389
Lead Sponsor	Odense University Hospital Collaborators: Rigshospitalet, Denmark, Zealand University Hospital, Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Herlev and Gentofte Hospital, Vejle Hospital
Conditions	Cancer of Rectum
Enrollment	39 participants
Start Date	2023-02-01
Primary Completion	2027-07 (estimated)
Study Completion	2052-02 (estimated)
Updated on ClinicalTrials.gov	2025-08-07