Study on Combining Ipilimumab, Degarelix, and Surgery for Men with Newly Diagnosed or Recurrent Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02020070

Provider View

This clinical trial is exploring the effects of combining the drugs ipilimumab and degarelix with surgery to treat men with newly diagnosed or recurrent prostate cancer that is sensitive to hormone therapy. The study aims to determine if this combination is safe and effective in managing prostate cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effects, both positive and negative, of using ipilimumab and degarelix before and after prostate surgery in men with prostate cancer. The trial aims to assess the safety and effectiveness of combining hormone therapy and immunotherapy in prostate cancer cases that are typically treated with hormones alone. There are two groups in this study: one for men with newly diagnosed prostate cancer that has spread to a few areas and is sensitive to hormone therapy, and another for men who have had surgery but whose cancer has returned.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older who can provide informed consent.
  • Diagnosed with prostate cancer that is sensitive to hormone therapy.
  • For Cohort A: Newly diagnosed prostate cancer with up to 10 bone metastases or distant lymph node involvement, and no more than 5 months of prior hormone therapy.
  • For Cohort B: Prostate cancer with rising PSA levels after surgery, indicating recurrence.
  • Good overall health with a performance status score of 80-100.
  • Normal organ function based on specific blood test results.
  • No active infections like HIV, Hepatitis B, or Hepatitis C.
  • Medically fit for prostate surgery.
  • Men must use effective contraception during the study and for 26 weeks after the last dose of ipilimumab.

Exclusion Criteria

  • Any other cancer within the last 5 years, except for certain skin or bladder cancers.
  • Major surgery within 4 weeks before starting the study.
  • Prior radiation therapy to the prostate, except for palliative treatment.
  • More than 5 months of prior hormone therapy.
  • Previous use of certain prostate cancer treatments like ketoconazole or enzalutamide.
  • Current or past use of experimental drugs for prostate cancer.
  • History of autoimmune diseases like rheumatoid arthritis or lupus.
  • Medical conditions that make ipilimumab treatment risky.
  • Recent use of non-oncology vaccines.
  • Previous treatment with ipilimumab or similar drugs.
  • Use of certain immunotherapy or immunosuppressive drugs within 6 weeks before the study.
  • Men unwilling to use contraception during and after the study.
  • History of certain gastrointestinal conditions that increase the risk of bowel perforation.

Get This Program In Your Inbox

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