Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer

Exclusion Criteria

• •Presence of known lymph node involvement or distant metastases
• •Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
• •Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer
• •Prior immunotherapy/vaccine therapy for prostate cancer
• •Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors (prior use of these agents is allowed).
• •Conditions requiring systemic treatment with either corticosteroids \> 10 mg daily prednisone equivalents or other immunosuppressive medications within 14 days of study treatment administration, except for adrenal replacement steroid doses \> 10 mg daily prednisone equivalent in the absence of active autoimmune disease.
• •(1) Treatment with a short course of steroids (\< 5 days) up to 7 days prior to initiating study treatment is permitted.
• •History of known or suspected autoimmune disease with the following exceptions:
• •* Vitiligo
• •* Resolved childhood atopic dermatitis
• •* Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
• •* Patients with Grave's disease or Hashimoto's thyroiditis that are now euthyroid clinically and by laboratory testing.
• •History of malignancy within the last 2 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
• •Known uncontrolled or significant cardiovascular disease including, but not limited, to any of the following:
• •1. Myocardial infarction or stroke/transient ischemic attack within the past 6 months.
• •2. Uncontrolled angina within the past 3 months.
• •3. Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
• •4. History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, or significant pericardial effusion).
• •5. History of myocarditis, regardless of etiology.
• •6. Cardiovascular disease-related requirement for daily supplemental oxygen therapy.
• •Known prior or current history of HIV.
• •Patients with known untreated hepatitis B/C or those with a detectable viral load.
• •Active infection ≤7 days prior to start of treatment.
• •Live vaccine within 30 days of start of treatment.
• •Prior history of hypersensitivity to a monoclonal antibody.