OMNIVORE supports nivolumab stop-early responders, not salvage ipilimumab

Nivolumab is a PD-1 checkpoint inhibitor, and ipilimumab is a CTLA-4 checkpoint inhibitor; OMNIVORE tested response-adapted immunotherapy in advanced RCC (Phase 2; NCT03203473). Among 83 patients, early nivolumab responders who stopped therapy after confirmed CR/PR had durable off-treatment control, with 6/12 off therapy at 1 year and 5 maintaining responses for >43 months; 3-year OS from nivolumab start was 83% in the stop-early arm. By contrast, adding short-course ipilimumab for nivolumab non-responders produced limited durability, with median PFS 4.6 months from nivolumab+ipilimumab start—far below modern frontline ICI/TKI benchmarks such as lenvatinib+pembrolizumab’s median PFS of 23.9 months in CLEAR.