Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-na ve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    1000
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 16 June 2021
Investigator
Toll Free Number
Primary Contact
Meir Medical Center ( Site 0544) (0.0 mi away) Contact
+226 other location
ct scan
cancer
prednisone
androgens
MRI
dexamethasone
testosterone
metastasis
docetaxel
antiandrogen therapy
androgen suppression
orchiectomy
enzalutamide
serum testosterone
castration-resistant prostate cancer
apalutamide
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 pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate tumor, prostate tumors
Treatment prednisone, docetaxel, Placebo, Dexamethasone, Pembrolizumab
Clinical Study IdentifierNCT03834506
SponsorMerck Sharp & Dohme Corp.
Last Modified on16 June 2021

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