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.

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