Study on Nivolumab for Prostate Cancer with Biochemical Recurrence and MMR Deficiency

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04019964

Provider View

This clinical trial is exploring the use of nivolumab, an immune therapy, as a potential treatment for men with prostate cancer that has returned after initial treatment and shows specific genetic markers. The study aims to provide an alternative to hormone therapy for these patients.

Patient Parameters

Program Overview

This study is investigating whether nivolumab, an immune therapy, can be an effective treatment for men whose prostate cancer has returned after initial treatment and who have specific genetic markers indicating MMR deficiency. These markers include high microsatellite instability (MSI-H), high tumor mutational burden (TMB), or alterations in certain genes. Currently, the standard treatment for such cases is either monitoring or hormone therapy, which may not improve survival. Nivolumab offers a non-hormonal option for patients with these genetic markers.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older who can provide informed consent.
  • Previously treated with surgery or radiation for prostate cancer.
  • PSA level of at least 1.0 ng/mL at screening.
  • Must have specific genetic changes in the cancer, such as MSI-H, MMR protein loss, or high TMB.
  • Testosterone level of at least 150 ng/dL.
  • No signs of cancer spread on recent scans.
  • Good overall health with a performance status of 70% or higher.
  • Normal organ and bone marrow function based on recent tests.
  • Life expectancy of at least 6 months.
  • Agree to use effective contraception during and after the study.
  • No other cancers in the past 5 years, except certain skin cancers.

Exclusion Criteria

  • Cancer that has spread or another active cancer.
  • Recent hormone therapy for prostate cancer.
  • Recent use of certain prostate cancer medications.
  • Participation in another clinical trial recently.
  • Previous treatment with certain immune therapies.
  • Active autoimmune diseases, except for certain stable conditions.
  • Need for high-dose steroids or other immune-suppressing drugs.
  • Positive tests for hepatitis B, hepatitis C, or HIV.
  • Severe allergies to study drugs.
  • Serious medical conditions that could make the study unsafe, such as uncontrolled infections or heart failure.

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