KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer

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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 )

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Author and article information

Contributors

Julie N Graff: (View ORCID Profile)

Journal

Title: Future Oncology

Abbreviated Title: Future Oncology

Publisher: Future Medicine Ltd

ISSN (Print): 1479-6694

ISSN (Electronic): 1744-8301

Publication date Created: August 2021

Publication date (Print): August 2021

Volume: 17

Issue: 23

Pages: 3017-3026

Affiliations

[1 ]Portland VA Health Care System, 3710 SW US Veterans Hospital Road, P3HOC, Portland, OR 97239, USA

[2 ]Knight Cancer Institute, 3485 SW Bond Avenue, Portland, OR 97239, USA

[3 ]MSD China, Building 21 Rongda Road, Chaoyang District, Beijing, China

[4 ]Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA

[5 ]Hoppe-Seylerstrasse 3, University of Tuebingen Medical Center, Tuebingen, D-72076, Germany

Article

DOI: 10.2217/fon-2020-1008

PubMed ID: 34044584

SO-VID: f95a0f2c-8677-4615-9b65-43eba82edd49

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KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer

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Abstract

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Most cited references 50

Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

The blockade of immune checkpoints in cancer immunotherapy.

Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade

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Cited by 11

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