Study on Pembrolizumab, Enzalutamide, and Hormone Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04191096

Provider View

This clinical trial is comparing the effectiveness and safety of a combination of pembrolizumab, enzalutamide, and hormone therapy against a placebo with enzalutamide and hormone therapy in men with metastatic hormone-sensitive prostate cancer.

Patient Parameters

Program Overview

The purpose of this study is to determine if combining pembrolizumab with enzalutamide and hormone therapy is more effective than using a placebo with enzalutamide and hormone therapy in treating metastatic hormone-sensitive prostate cancer. The study will look at how long patients live without the cancer getting worse and overall survival rates. As of January 2023, the study was unblinded, meaning all participants stopped receiving pembrolizumab or placebo and will continue with standard care if they are benefiting. Safety will be analyzed at the end of the study, but no further effectiveness data will be collected. Participants who are benefiting from the combination of enzalutamide and pembrolizumab may continue treatment after consulting with their doctor and the study sponsor.

Eligibility Criteria

Inclusion Criteria

  • Men with confirmed prostate cancer that has spread to other parts of the body.
  • Cancer must be visible on scans, either in bones or other organs.
  • Willing to continue hormone therapy during the study or have had surgical removal of the testicles.
  • Good overall health with a performance status score of 0 or 1.
  • Stable doses of bone-strengthening therapy if applicable.
  • Adequate organ function.
  • Provide a recent biopsy sample from a tumor.
  • Agree to avoid fathering children during the study and for 120 days after the last dose, using contraception or abstaining from sex.
  • Agree to use a condom during sexual activity.

Exclusion Criteria

  • Have another active cancer that required treatment in the last 3 years.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have an immune deficiency or are on long-term steroid therapy.
  • Have had major surgery within 28 days before starting the study and not fully recovered.
  • Have a digestive disorder affecting medication absorption or cannot swallow pills.
  • Have an active infection needing treatment.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have active HIV, hepatitis B, or hepatitis C infection.
  • Have cancer spread to the brain or spinal cord.
  • Have a history of seizures or conditions that may cause seizures.
  • Have had a heart attack or severe heart issues in the past 6 months.
  • Have uncontrolled blood pressure issues.
  • Have severe heart rhythm problems.
  • Are allergic to pembrolizumab or enzalutamide.
  • Have had hormone therapy for prostate cancer for more than 39 months or within 9 months before starting the study.
  • Have had previous treatment with certain hormonal or immune therapies.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a specific type of bone scan result known as a "superscan."
  • Have had a tissue or organ transplant.
  • Plan to have children during the study or within 120 days after the last dose.
  • Have had previous treatments for metastatic prostate cancer, except for specific allowed therapies.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.