Study of Cabozantinib and Nivolumab in Advanced Prostate Cancer Resistant to Hormone Therapy

Sponsor: Rana McKay, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05502315

Provider View

This clinical trial is testing a combination of two drugs, cabozantinib and nivolumab, to see if they can help treat advanced prostate cancer that no longer responds to hormone therapy. The study involves taking these medications and undergoing regular health checks to monitor progress.

Patient Parameters

Program Overview

This study is exploring the effects of combining two drugs, cabozantinib and nivolumab, in treating advanced prostate cancer that has become resistant to hormone therapy. Participants will take cabozantinib daily by mouth and receive nivolumab through an IV every four weeks. The study will monitor the cancer's response through regular scans and blood tests, and participants will continue treatment until the cancer progresses, side effects become too severe, or they choose to stop.

Description

Participants in this study will first have a biopsy to collect a sample of their cancer before starting treatment. They will then begin taking cabozantinib daily and receive nivolumab every four weeks. Another biopsy will be done during the second cycle of treatment to see how the cancer is responding. The treatment will continue until the cancer shows signs of growing, side effects become too severe, or the participant decides to stop. Prostate-specific antigen (PSA) levels will be checked every cycle, and scans will be done every two cycles for the first year, then every three cycles after that. Each cycle lasts 28 days.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older.
  • Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
  • Have a specific level of physical health (ECOG status of 0 to 2).
  • Cancer must be progressing, shown by rising PSA levels or scans.
  • Must have tried one taxane chemotherapy and one AR-targeting therapy, unless unable or unwilling to do so.
  • Must have normal organ function and acceptable blood test results.
  • Must agree to use effective birth control during the study.
  • HIV-positive individuals can participate if their viral load is controlled and CD4 count is above 350.

Exclusion Criteria

  • Cancer has progressed on previous checkpoint inhibitor treatment.
  • Previously treated with cabozantinib.
  • Recent use of certain cancer treatments or vaccines.
  • Active autoimmune disease requiring high-dose steroids.
  • Uncontrolled or significant health issues, such as heart problems or infections.
  • Recent major surgery or significant bleeding issues.
  • Known allergies to study drugs.
  • Inability to swallow tablets.

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