@article{f84310472af64e0e844a71fc4b8102f9,
title = "KEYNOTE-641: A Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer",
abstract = "Current treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) are noncurative, and median survival upon development of mCRPC is approximately 3 years. The novel hormonal agent enzalutamide has an established role in the mCRPC treatment paradigm, and emerging evidence suggests potential synergism with enzalutamide and the PD-1 inhibitor pembrolizumab in men with mCRPC. Here, we describe the design and rationale for the multicenter, randomized, double-blind, Phase III KEYNOTE-641 study, which will be conducted to compare the efficacy and safety of pembrolizumab plus enzalutamide with that of enzalutamide plus placebo in mCRPC. Clinical trial registration: NCT03834493 (ClinicalTrials.gov.",
keywords = "PD-1, PD-L1, castration resistant, enzalutamide, mCRPC, pembrolizumab, prostate cancer",
author = "Graff, {Julie N.} and Liang, {Li Wen} and Jeri Kim and Arnulf Stenzl",
note = "Funding Information: Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. JN Graff: Institutional Research funding from Merck, Astellas/Pfizer, Janssen and Sanofi. LW Liang: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and a stockholder of Merck & Co., Inc., Kenilworth NJ, USA. J Kim: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and a stockholder of Merck & Co., Inc., Kenilworth NJ, USA. A Stenzl: Received research funding from Merck associated with the submitted work; is a consultant for Ipsen Pharma, Janssen, Alere, Bristol Myers Squibb, Stebabiotech, Synergo, Ferring and Astellas; is a speaker for Janssen, Ipsen Pharma, CureVac, Astellas, Amgen and Sanofi Aventis; has received grant support (outside submitted work) for clinical studies from Johnson & Johnson, Roche, Cepheid, Bayer AG, Immatics Biotechnologies, GmbH; and received research grants (outside submitted work) from Ipsen Pharma, Janssen, Stebabiotech, Ferring, Astellas, Amgen, Immatics Biotechnologies, GmbH, Novartis AG and Karl Storz AG. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} 2021 Future Medicine Ltd.. All rights reserved.",
year = "2021",
month = aug,
doi = "10.2217/fon-2020-1008",
language = "English (US)",
volume = "17",
pages = "3017--3026",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "23",
}