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

NCT04301414 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: AAAS3560
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 compared to degarelix alone. People who usually have this type of prostate cancer usually do not receive any additional therapy prior to surgery. Approximately 24 individuals will be asked to participate in this study.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with an adverse event will be reported with an exact binomial 95% confidence interval

  Characterizing the safety, tolerability, and feasibility of degarelix with or without BMS-986218 in the neoadjuvant setting. All subjects receiving at least one dose of the study drug(s) will be evaluable for toxicity.

  42 months

Secondary Outcomes (5)

• Mean Treg cell staining percentage in harvested prostate tissues will be reported and compared post-treatment between the treatment groups using paired sample test.

  42 months

• Pathological complete responses (pCR)- an absence of tumor identification on standard histological analysis of the resected prostate specimens.

  42 months

• Undetectable PSA at 12 months- the proportion of patients who achieve an undetectable PSA (<0.1 ng/mL) by 12 months after prostatectomy

  42 months

• PSA response rates- a 50% change in pre-treatment and post-treatment PSA.

  42 months

• Time to PSA recurrence- the interval from the time of prostatectomy to the time when the first of at least two serial rises in PSA (≥2 weeks apart) with a PSA ≥0.2 ng/mL.

  42 months

Study Arms (3)

Safety lead-in

OTHER

The first 4 subjects enrolled will be given degarelix plus BMS-986218.

Drug: BMS-986218 and Degarelix

Arm A

ACTIVE COMPARATOR

Degarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy

Drug: Degarelix

Arm B

EXPERIMENTAL

BMS-986218 20mg IV every 2 weeks x 2 doses starting 3 weeks prior to radical prostatectomy plus degarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy.

Drug: BMS-986218 and Degarelix

Interventions

BMS-986218 and Degarelix DRUG

BMS-986218 20mg IV every 2 weeks x 2 doses starting 3 weeks prior to radical prostatectomy plus degarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy.

Arm B; Safety lead-in

Degarelix DRUG

Degarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Bristol-Myers Squibb: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Karie D. Runcie, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: February 25, 2020
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)