Surrogate endpoints for overall survival in anti-programmed death-1 and anti-programmed death ligand 1 trials of advanced melanoma.

Run-Cong NieShu-Qiang YuanYun WangXue-Bin ZouShi ChenShu-Man LiJin-Ling DuanJie ZhouGuo-Ming ChenTian-Qi LuoZhi-Wei ZhouYuan-Fang Li

Published in: Therapeutic advances in medical oncology (2020)

PFS may be the appropriate surrogate for OS in anti-PD-1/PD-L1 trials of metastatic melanoma. A future anti-PD-1/PD-L1 trial would need less than 0.78 for PFS of the upper limit of confidence interval to predict an OS benefit.

Keyphrases

study protocol
clinical trial
phase iii
current status
phase ii
randomized controlled trial
open label