Pembrolizumab + Enzalutamide for Prostate Cancer

Recruiting at265 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

Men with metastatic castration-resistant prostate cancer who haven't had chemotherapy for it, are either naive to or have not progressed on abiraterone acetate, and whose cancer has worsened despite hormone therapy. Participants must have a low testosterone level, be willing to avoid fathering children during the study, and cannot have had certain prior treatments including specific anti-cancer drugs.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I have a recent biopsy from a non-irradiated area or from a tumor in a previously radiated area.

I have been on a stable dose of medication for bone health before joining the study.

Exclusion Criteria

I am currently being treated for an active infection.

I have a condition that affects how my body absorbs food or I can't swallow pills.

I have or had lung inflammation that needed steroids.

Treatment Details

Interventions

• Enzalutamide (Hormone Therapy)
• Pembrolizumab (Checkpoint Inhibitor)
• Placebo ()

Trial Overview The trial is testing if pembrolizumab combined with enzalutamide improves survival compared to placebo plus enzalutamide in men with advanced prostate cancer. It looks at overall survival and time without disease progression using scans reviewed by experts blinded to treatment assignment.

Participant Groups

Group I: Pembrolizumab + Enzalutamide Experimental Treatment 2 Interventions

Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.

Group II: Placebo + Enzalutamide Placebo Group 2 Interventions

Participants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.

Enzalutamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Japan as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University