Trial Purpose

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.

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

Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide 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.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT03834493

When speaking to your doctor, please have the trial identifier number available.

About The Trial

All patients who enroll in the trial will receive medication while on the study.

50% will receive pembrolizumab along with enzalutamide

50% will receive placebo along with enzalutamide

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Phase 3

Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.

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Dates

  • Actual study start date July 28, 2019
  • Estimated primary completion date December 12, 2022
  • Estimated study completion date May 31, 2024

Eligibility

Conditions Icon

Conditions

Prostatic Neoplasms

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Age Range

18 - No Age Maximum

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Sex

Male

Trial locations

What Can You Do Next?

If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.

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Discuss With Your Doctor

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CLINICALTRIALS.GOV IDENTIFIER:

NCT03834493

When speaking to your doctor, please have the trial identifier number available.

Participating in a clinical trial is an important decision.

Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.