Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC

NIPIRESCUE is a national, single-arm, open-label phase II study, evaluating nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and VEGF or anti-EGFR therapy. Patients after inclusion will receive: Induction therapy with nivolumab 240 mg and ipilimumab 1 mg/kg every 3 weeks for 4 dosing cycles (4 infusions of nivolumab and ipilimumab) and maintenance therapy with by nivolumab 480 mg every 4 weeks (21 infusions). The primary endpoint is ORR at 24 weeks (6 months) from the beginning of the treatment evaluated by RECIST 1.1.