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

Korábbi kezelés

• 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.
• Known prior or current history of HIV.
• 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.

Más betegség

• Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
• 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:
  • Myocardial infarction or stroke/transient ischemic attack within the past 6 months.
  • Uncontrolled angina within the past 3 months.
  • Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
  • 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).
  • History of myocarditis, regardless of etiology.
  • Cardiovascular disease-related requirement for daily supplemental oxygen therapy.
• Patients with known untreated hepatitis B/C or those with a detectable viral load.

Laborértékek

• 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.

Egyéb

• Presence of known lymph node involvement or distant metastases

• Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs
• Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥4+3
• Radical prostatectomy has been scheduled at Columbia University Irving Medical Center
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)
• Adequate bone marrow, hepatic, and renal function:
  • White blood cell count (WBC) \>3,000 cells/mm3
  • Absolute neutrophil count (ANC)\>1,500 cells/mm3
  • Hemoglobin \>9.0 g/dL
  • Platelet count \>100,000 cells/mm3
  • Serum creatinine \<1.5 × upper limit of normal (ULN)
  • Serum bilirubin \<1.5 × ULN
  • Alanine transaminase (ALT) \<3 × ULN
  • Aspartate aminotransferase (AST)\<3 × ULN
  • Alkaline phosphatase \<3 × ULN
• Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
• Willingness to use barrier contraception from the time of first dose of BMS-986218 until 165 days from the last dose of BMS-986218.