Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2026
  • participants needed
    1232
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 14 July 2021
Investigator
Toll Free Number
Primary Contact
Gallipoli Medical Research Foundation ( Site 0309) (8.6 mi away) Contact
+223 other location

Summary

This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).

Details
Condition Metastatic Hormone Sensitive Prostate Cancer
Treatment Placebo, Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT)
Clinical Study IdentifierNCT04191096
SponsorMerck Sharp & Dohme Corp.
Last Modified on14 July 2021

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