Study on Combining Ipilimumab with Abiraterone Acetate and Prednisone for Patients with Advanced Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT01688492

This clinical trial is exploring the effects of combining ipilimumab with abiraterone acetate and prednisone in patients with advanced prostate cancer that has spread and is resistant to hormone therapy. The study aims to determine how well these drugs work together and their impact on the cancer and the patient's health.

Patient Parameters

Program Overview

The purpose of this study is to see how the combination of ipilimumab, abiraterone acetate, and prednisone affects patients with advanced prostate cancer that has spread and is resistant to hormone therapy. Abiraterone acetate and prednisone are used to lower testosterone levels, which can help slow the growth of prostate cancer. This study will test how these drugs work when used together with ipilimumab, an immunotherapy drug. Each participant will receive all three medications as part of the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to give informed consent.
  • Have a confirmed diagnosis of prostate cancer that has spread and is resistant to hormone therapy.
  • Must have low testosterone levels due to ongoing hormone therapy or surgical removal of the testicles.
  • Cancer must be visible on imaging tests, such as bone scans or CT/MRI scans, and must have spread beyond the pelvic lymph nodes.
  • Must show signs of cancer progression based on PSA levels or imaging tests.
  • Must have a good overall health status with a performance score of 80-100 and an expected life expectancy of at least 6 months.
  • Any side effects from previous treatments must have improved to a mild level or be considered stable.
  • Must be able to swallow pills and follow study procedures.

Exclusion Criteria

  • Have had another type of cancer within the last 5 years, except for certain skin cancers.
  • Have low blood cell counts or low hemoglobin levels at the screening visit.
  • Have high liver enzyme levels or bilirubin levels, unless due to Gilbert's disease.
  • Have high creatinine levels, low albumin, or low potassium levels at the screening visit.
  • Have significant heart disease or uncontrolled high blood pressure.
  • Have had major surgery or radiation therapy within 4 weeks before starting the study.
  • Have used certain hormone-blocking medications within 4 weeks before starting the study.
  • Have a history of prostate cancer progression while on ketoconazole or similar treatments.
  • Have allergies to any study drugs.
  • Have uncontrolled medical conditions that could interfere with the study.
  • Have autoimmune diseases like inflammatory bowel disease or lupus.
  • Have known or suspected brain cancer spread or untreated brain lining disease.
  • Have active infections or medical conditions that make prednisone use unsafe.
  • Have active or symptomatic viral hepatitis or chronic liver disease.

Locations

FACILITYZIPCITYSTATE
Northwestern University60208EvanstonIllinois
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Oregon Health & Science University97239PortlandOregon

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