Dr. Shoushtari on the Design of the 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.