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 Burgents; Karim Fizazi

doi:10.2217/fon-2020-1133

KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer

Future Oncol. 2021 Sep;17(25):3291-3299. doi: 10.2217/fon-2020-1133. Epub 2021 Jun 8.

Authors

Affiliations

¹ Department of Internal Medicine, Smilow Cancer Hospital, Yale School of Medicine, New Haven, CT 06511, USA.
² Department of Medical Oncology, Foch Hospital, Suresnes, 92151, France.
³ Department of Oncourology, Russian Scientific Center of Roentgen Radiology, Moscow, 117997, Russia.
⁴ Departmental Unit of Experimental Uro-Androlo, Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale, Naples, 80131, Italy.
⁵ Department of Medical Oncology, Catalan Institute of Oncology, Barcelona, 08908, Spain.
⁶ Department of Urology, Medical University of Vienna, Vienna, 1090, Austria.
⁷ Department of Medicine, University of Colorado School of Medicine, Aurora, CO 80045, USA.
⁸ Department of Medical Oncology, Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI 49503, USA.
⁹ Department of Clinical Research, Merck & Co., Inc., Kenilworth, NJ 07033, USA.
¹⁰ Department of Cancer Medicine, Institut Gustave Roussy and University of Paris Saclay, Villejuif, 94800, France.

PMID: 34098744
DOI: 10.2217/fon-2020-1133

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).

Keywords: metastatic castration-resistant prostate cancer; pembrolizumab.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Antibodies, Monoclonal, Humanized / administration & dosage*
Antibodies, Monoclonal, Humanized / adverse effects
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Clinical Trials, Phase III as Topic
Docetaxel / administration & dosage*
Docetaxel / adverse effects
Double-Blind Method
Humans
Male
Middle Aged
Multicenter Studies as Topic
Prednisolone / administration & dosage
Prednisolone / adverse effects
Prednisone / administration & dosage
Prednisone / adverse effects
Progression-Free Survival
Prostate / diagnostic imaging
Prostate / pathology
Prostatic Neoplasms, Castration-Resistant / diagnosis
Prostatic Neoplasms, Castration-Resistant / drug therapy*
Prostatic Neoplasms, Castration-Resistant / mortality
Prostatic Neoplasms, Castration-Resistant / pathology
Randomized Controlled Trials as Topic

Substances

Antibodies, Monoclonal, Humanized
Docetaxel
Prednisolone
pembrolizumab
Prednisone

Associated data

ClinicalTrials.gov/NCT03834506

Grants and funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA