Study design: CheckMate 067 Study Design (melanoma)
- Phase 3, randomized, multicenter, double-blind study in patients with unresectable/metastatic melanoma1
- To compare NIVO + IPI or NIVO monotherapy with IPI monotherapya,1
- Co-primary endpointsa: PFS and OS in the NIVO-containing arms vs IPI monotherapy1
aThe study was not powered for a comparison of NIVO + IPI and NIVO.
Figure adapted from Larkin et al. 2019.1
AJCC, American Joint Committee on Cancer; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IPI, ipilimumab; NIVO, nivolumab; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; QxW, every x weeks; R, randomization.
1. Larkin J, et al. N Engl J Med 2019;381:1535–1546.