Alexander N. Shoushtari, MD, discusses the design of the phase 3 CheckMate-067 trial in advanced melanoma.
Alexander N. Shoushtari, MD, an assistant attending physician at Memorial Sloan Kettering Cancer Center, discusses the design of the phase 3 CheckMate-067 trial in advanced melanoma.
The study randomized patients with previously untreated, unresectable, stage III or IV melanoma 1:1:1 to receive 1 mg/kg of nivolumab (Opdivo) plus 3 mg/kg of ipilimumab (Yervoy) for 4 doses, followed by 3 mg/kg of nivolumab; 3 mg/kg of nivolumab plus ipilimumab-matched placebo; or 3 mg/kg of ipilimumab for 4 doses plus nivolumab-matched placebo until progression or unacceptable toxicity, says Shoushtari.
Less common subtypes, such as mucosal and acral melanoma, were included in the study, but the majority of patients had cutaneous melanoma, adds Shoushtari. Notably, patients with uveal melanoma were excluded.
Ultimately, the trial was powered to detect a difference in progression-free survival and overall survival between nivolumab and ipilimumab, as well as between the combination of nivolumab and ipilimumab and ipilimumab monotherapy, Shoushtari explains.
The difference in efficacy between nivolumab monotherapy and the combination regimen, as well as the long-term outcomes of patients with mucosal melanoma served as exploratory analyses of the study, Shoushtari concludes.