A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1.

Sarah A Weiss Mario Sznol Montaser Shaheen Miguel-Angel Berciano-Guerrero Eva Muñoz Couselo Delvys Rodríguez-Abreu Valentina Boni Lynn M Schuchter Maria Gonzalez Cao Ana M Arance Wei Wei Apar Kishor Ganti Ralph J Hauke Alfonso Berrocal Nicholas O Iannotti Frank J Hsu Harriet M Kluger

Published in: Clinical cancer research : an official journal of the American Association for Cancer Research (2023)

Sotigalimab plus nivolumab had a favorable safety profile consistent with the toxicity profiles of each agent. The combination resulted in durable and prolonged responses in a subset of patients with anti-PD-1-resistant melanoma, warranting further evaluation in this setting.

Keyphrases

oxidative stress
open label
clinical trial
randomized controlled trial
placebo controlled
double blind