Status:
COMPLETED
Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Bristol-Myers Squibb
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to see whether immunotherapy with BMS-986218 added to degarelix (which suppresses testosterone) given prior to surgery can decrease the chance that cancer will come back c...
Detailed Description
This is a single-center, randomized, two-arm, study evaluating the safety, feasibility and immunogenicity of neoadjuvant degarelix(Arm A) or BMS-986218 plus degarelix (Arm B) prior to radical prostate...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- 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.
- 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.
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04301414
Start Date
February 25 2020
End Date
March 13 2025
Last Update
August 7 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032