KEYNOTE-921: Phase III Study of Pembrolizumab Plus Docetaxel for Metastatic Castration-Resistant Prostate Cancer
Daniel P. Petrylak, Raffaele Ratta, Rustem Gafanov, Gaetano Facchini, Josep M. Piulats, Gero Kramer, Thomas W. Flaig, Sreenivasa R Chandana, Ben Li, Joseph E. Burgents, Karim Fizazi
Abstract
Despite recent advances, treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) progressing after next-generation hormonal agents (NHAs) are limited and provide only modest survival benefit. Thus, an unmet need remains for mCRPC patients after treatment with targeted endocrine therapy or NHA therapy. Pembrolizumab, a humanized monoclonal antibody for PD-1, has been found to have activity as monotherapy in patients with mCRPC and as combination therapy in a Phase Ib/II study with docetaxel and prednisone/prednisolone for patients previously treated with enzalutamide or abiraterone acetate. The aim of the randomized, double-blind, Phase III KEYNOTE-921 study is to evaluate the efficacy and safety of pembrolizumab plus docetaxel in patients with mCRPC who were previously treated with an NHA. Clinical trial registration: NCT03834506 (ClinicalTrials.gov)