This early phase I trial identifies the safety of degeralix acetate alone or in combination with immunotherapy drug (BMS-986218) when given prior to surgery in treating patients with high risk prostate cancer that has not spread to other parts of the body (localized). This study will also assess the effect of degeralix acetate alone or in combination with BMS-986218 in decreasing the chance of cancer coming back. Testosterone may cause the growth of prostate cancer cells. Degarelix acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Immunotherapy with monoclonal antibodies, such as BMS-986218, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04301414.
PRIMARY OBJECTIVE:
I. To confirm the safety and feasibility of degarelix acetate (degarelix) (Arm A) or degarelix plus anti-CTLA4 monoclonal antibody BMS-986218 (BMS-986218) (Arm B) administered using a standard dose/schedule in the neo-adjuvant setting.
SECONDARY OBJECTIVES:
I. To test the hypothesis that neoadjuvant BMS-986218 plus degarelix decreases the regulatory T cell (Treg) density compared to degarelix alone in primary prostate tumors.
II. To estimate CD8+ T cell density and CD8+ T cell/Treg ratio changes after neoadjuvant BMS-986218 plus degarelix treatment as compared to degarelix alone in primary prostate tumors.
III. To estimate the pathologic complete response rate following neoadjuvant BMS-986218 plus degarelix as compared to degarelix alone treatment.
IV. To estimate the undetectable prostate specific antigen (PSA) 12 months with neoadjuvant BMS-986218 plus degarelix following radical prostatectomy compared to degarelix alone treatment.
V. To estimate the PSA response rate (> 50% decrease in PSA) prior to radical prostatectomy with neoadjuvant BMS-986218 plus degarelix compared to degarelix alone treatment.
VI. To estimate time to PSA recurrence following radical prostatectomy after neoadjuvant BMS-986218 plus degarelix compared to degarelix alone treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive degarelix acetate subcutaneously (SQ) on day 1 and undergo standard of care radical prostatectomy on day 15 in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive BMS-986218 intravenously (IV) over 30 minutes on days 1 and 15 and degarelix acetate SQ on day 8. Patients then undergo standard of care radical prostatectomy on day 22 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 90 days, every 3 months for 1 year, and then every 6 months for 1 year.
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorKarie Runcie