Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    780
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 30 June 2021
ct scan
cancer
prednisone
androgens
MRI
testosterone
metastasis
docetaxel
antiandrogen therapy
androgen suppression
abiraterone
orchiectomy
enzalutamide
serum testosterone
castration-resistant prostate cancer
tumor progression
adenocarcinoma
bisphosphonate
adenocarcinoma of prostate
metastatic castration-resistant prostate cancer
diphosphonates

Summary

The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.

The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:

  1. Overall Survival (OS) and
  2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate tumor, prostate tumors
Treatment prednisone, Pembrolizumab, Enzalutamide, olaparib, abiraterone acetate
Clinical Study IdentifierNCT03834519
SponsorMerck Sharp & Dohme Corp.
Last Modified on30 June 2021

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