Study on Nivolumab and BMS-986253 for Treating Hormone-Sensitive Prostate Cancer (MAGIC-8)

Sponsor: Mark Stein

Sponsor score: 0

ClinicalTrials ID:NCT03689699

Provider View

This clinical trial is exploring whether the immunotherapy drugs Nivolumab and BMS-986253, combined with hormone therapy using Degarelix, can safely reduce the risk of prostate cancer returning in men with hormone-sensitive prostate cancer.

Patient Parameters

Program Overview

The MAGIC-8 study is testing two different treatments for men with hormone-sensitive prostate cancer that shows a rising PSA level. The study aims to find out if using Nivolumab alone or with BMS-986253, along with Degarelix (a hormone therapy that lowers testosterone), is safe and effective in preventing the cancer from coming back. Researchers will look at how many patients experience a rise in PSA levels after 10 months of treatment and assess the safety of these treatments. They will also study how long patients remain free from cancer and how PSA levels change with the treatment.

Description

Prostate cancer is a common disease in men and can lead to serious health issues. After initial treatments like surgery or radiation, some men experience a return of cancer, either through rising PSA levels or visible spread of the disease. Hormone therapy, which reduces testosterone, is a common treatment but can have side effects like tiredness, hot flashes, and bone loss. This study is looking for new ways to reduce the time men need hormone therapy, improving their quality of life.

The study involves using hormone therapy either continuously or in cycles, but over time, the effectiveness of these cycles can decrease. New treatment strategies are needed to better control the disease while reducing hormone therapy exposure for men with early-stage prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer from a biopsy or surgery.
  • Must be 18 years or older.
  • Must have had initial treatment for prostate cancer, with any additional treatments like radiation or cryotherapy done at least 6 months before joining the study.
  • Must have a rising PSA level, defined as:
    • For those who had surgery, two rising PSA levels above 0.2 ng/mL, with the last one above 2.0 ng/mL.
    • For those who had other treatments, a rise according to specific criteria.
  • Must be willing to have biopsies before and during treatment.
  • Must have a PSA doubling time of 12 months or less, calculated from at least three PSA tests.
  • Must be in good health with a performance status score of 0-1.
  • Must have testosterone levels of at least 150 ng/dL within 28 days before joining.
  • Must have adequate blood, liver, and kidney function based on specific tests.
  • Must agree to use contraception during and after treatment for a specified period.
  • Must be willing to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Have received experimental immunotherapy within a year before joining.
  • Have a PSA level over 50 at enrollment.
  • Have extensive disease with more than 5 bone metastases or large lymph nodes.
  • Have a different type of prostate cancer, except for a limited number of cases with ductal prostate cancer.
  • Have had recent radiation or hormone therapy within 6 months before joining.
  • Have had chemotherapy or certain growth factors within 90 days before joining.
  • Have had major surgery within 28 days before joining.
  • Have an active infection or fever within a week before joining.
  • Have been on immunosuppressive therapy recently, except for certain conditions.
  • Have participated in an anti-IL8 study before.
  • Are scheduled for additional prostate cancer treatments during the study.
  • Are taking other hormonal therapies or certain medications.
  • Have a history of autoimmune diseases, with some exceptions.
  • Have had another cancer within the last 2 years, except for certain skin or bladder cancers.
  • Have uncontrolled infections or other serious health issues.
  • Have a history of HIV or hepatitis B/C.
  • Have had an organ transplant.

Locations

FACILITYZIPCITYSTATE
Winship Cancer Institute, Emory University30322AtlantaGeorgia
Weill Cornell Medical Center10021New YorkNew York
Columbia University Irving Medical Center10032New YorkNew York
Sidney Kimmel Cancer Center- Thomas Jefferson University19107PhiladelphiaPennsylvania

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