Study of Opevesostat (MK-5684) Versus Other Treatments in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06136624

Provider View

This clinical trial is comparing the new drug opevesostat with other existing treatments for men with metastatic castration-resistant prostate cancer (mCRPC) to see which is more effective in extending life and delaying cancer progression.

Patient Parameters

Program Overview

This study is testing a new drug called opevesostat against other treatments like abiraterone acetate or enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC). The goal is to see if opevesostat can help patients live longer and slow down the progression of their cancer. Participants in this study have already been treated with hormonal therapy and chemotherapy. The study will measure overall survival and how long patients live without their cancer getting worse, using specific criteria to evaluate the results.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that has spread and does not respond to hormone therapy.
  • Cancer has progressed while on hormone therapy or after surgical removal of the testicles.
  • Evidence of cancer spread to bones or soft tissues.
  • Cancer worsened during or after treatment with one novel hormonal agent (NHA).
  • Received one or two chemotherapy treatments for mCRPC and cancer continued to progress.
  • Ongoing hormone therapy with low testosterone levels.
  • Provided a tumor sample from a recent biopsy.
  • Good overall health with a performance status score of 0 or 1.
  • Previously treated with or ineligible for certain other cancer treatments.
  • Stable on bone-strengthening therapy if applicable.
  • Well-controlled HIV, hepatitis B, or hepatitis C infections if present.
  • Men who can father children must agree to use contraception during and after treatment.

Exclusion Criteria

  • Digestive issues affecting medication absorption.
  • History of pituitary gland problems.
  • Poorly controlled diabetes.
  • Abnormal blood potassium or sodium levels.
  • History of serious heart or blood vessel problems.
  • Recent seizures or conditions that increase seizure risk.
  • History of serious heart rhythm problems.
  • Recent treatment with certain cancer antibodies or not recovered from their side effects.
  • Recent major surgery or not fully recovered from surgery.
  • Use of certain herbal or medicinal products affecting prostate cancer.
  • Recent treatment with specific cancer therapies or not recovered from their side effects.
  • History of other active cancers or treatments within the last three years.
  • Active brain cancer spread or meningitis.
  • Active autoimmune diseases needing treatment in the last two years.
  • Active infections needing treatment.
  • Active hepatitis B or C infections.
  • History of long QT syndrome.
  • Blood pressure issues not controlled with medication.
  • Difficulty swallowing pills.
  • Use of certain medications affecting liver enzymes or hormone levels.

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