A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer

NCT07335796 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-262
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to find out whether BMS986365 in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Memorial Sloan Kettering Cancer Center; 25-262

Outcome Measures

Primary Outcomes (1)

• Frequency of pathologic complete response/pCR

  The primary objective is to determine the frequency of achieving a pathologic complete response (pCR) and/or minimal residual disease (MRD defined as ≤ 5 mm tumor) .

  42 months

Study Arms (1)

Participants with high-risk localized prostate cancer

EXPERIMENTAL

Eligible participants with high-risk localized prostate cancer based on one or more of the following: PSA \>20ng/ml, Gleason Score ≥8, or Clinical stage ≥cT3a.

Drug: BMS-986165; Drug: Degarelix

Interventions

BMS-986165 DRUG

BMS986365 (CC-94676) is an androgen receptor (AR) ligand-directed degrader that was designed to target the AR for degradation in castration-resistant prostate cancer (CRPC)

Participants with high-risk localized prostate cancer

Degarelix DRUG

Degarelix is a GnRH antagonist that blocks the action of GnRH on the pituitary and effectively suppresses testosterone production

Participants with high-risk localized prostate cancer

Eligibility Criteria

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

You may qualify if:

• Participant or participant's legally authorized representative (LAR) is willing and able to provide written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
• Individuals with prostate cancer 18 years of age and above
• Histological or cytological evidence of prostate cancer
• Documented high-risk localized prostate cancer based on one or more of the following NCCN criteria:
• PSA ≥ 20ng/ml or
• Gleason ≥8 or
• Clinical stage ≥cT3a
• Candidate for RP as determined by treating physician
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Normal organ function with acceptable initial laboratory values within 28 days of registration:
• ANC ≥ 1.5 K/mcL Hemoglobin ≥ 9g/dL Platelet count ≥ 100 K/mcL Potassium\* within institutional normal range Calcium\* within institutional normal range Magnesium\* within institutional normal range Total Bilirubin ≤ 1.5 x ULN (Note: In participants with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible) SGOT (AST) ≤ 2.5 x ULN SGPT (ALT) ≤ 2.5 x ULN CrCl\*\* \> 60 mL/min \*If these electrolytes are corrected with supplements, eligibility should be confirmed prior to the first dose of study intervention.
• \*\*Using Cockcroft-Gault equation or measured CrCl using 24-hour urine collection
• \- Male Participants: i) A participant who is sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for method(s) of contraception as described below and included in the informed consent form.
• Note: Azoospermic males are not exempt from contraceptive requirements and will be required to always use a latex or other synthetic condom during any sexual activity (e.g., vaginal, anal, oral) with IOCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant. ii) Participants will be required to always use a latex or other synthetic condom during any sexual activity (e.g., vaginal, anal, oral) with IOCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male (as assigned at birth) participants should continue to use a condom during the intervention period and for at least 2 months (for BMS-986365) and as per the label for degarelix after the last dose of study intervention.
• iii) IOCBP partners of participants should be advised to use a highly effective method of contraception during the intervention period and for at least 2 months (for BMS-986365) and as per the label for degarelix after the last dose of study intervention for the male participant.

You may not qualify if:

• Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan (any PET modality)
• Patients with N1 disease may be eligible for the study if planned for a radical prostatectomy per standard-of-care/institutional guidelines.
• On ADT (GnRH agonists or antagonists) for \> 4 weeks at time of consent
• Other than ADT as mentioned in 6.2.2, prior systemic therapy for treatment of their prostate cancer, including but not limited to chemotherapy, immunotherapy, etc.
• Prior local therapy to the prostate for prostate cancer, including but not limited to radiation, HIFU, phototherapy, etc.
• Participants who are considered a poor medical risk due to a serious, uncontrolled medical disorder, or recovering from a recent surgery (approximately within 1 month, or as deemed recent per surgeon), for which in the opinion of the investigator would interfere with treatment on this study.
• Any patient who cannot swallow oral medications or have gastrointestinal disorders in the opinion of the investigator are likely to interfere with absorption.
• Participant has impaired cardiac function or clinically significant cardiac disease, including any of the following:
• i. LVEF \< 50% as determined by ECHO or MUGA scan at Screening. ii. Complete left bundle branch, high-grade AV block (eg, bifascicular block, Mobitz type II and third-degree AV block), or other clinically significant abnormal ECG finding at Screening. Participant with a permanent pacemaker are excluded. iii. History of clinically significant sinus bradycardia or sick sinus syndrome or bradycardia with heart rate \< 50 bpm at Screening. (Note: All is determined by the average of the triplicate Screening ECG, based on local reading.)
• A prolongation of the QT interval on Screening ECG as defined by repeated demonstration of a QTc interval ≥ 450 ms using QTcF.
• Participant would be excluded if the QTcF interval cannot be determined on the Screening ECG (eg, unreadable or not interpretable).
• In the presence of right bundle branch block, if measured QTcF is \> 450 ms at baseline, then the ECG for QTc reading should be verified by a cardiologist to confirm eligibility. iv. A history of sustained ventricular tachycardia, ventricular fibrillation, TdP, or resuscitated cardiac arrest, individual or family history of long QT syndrome, or cardiomyopathy. v. Concurrent treatment with antiarrhythmic or other drugs that prolong the QT interval.
• For study eligibility, a washout period of ≥ 5 half-lives must have elapsed prior to the first dose of study intervention. vi. Congestive heart failure (New York Heart Association Class III or IV) ≤ 12 months prior to the first dose of study intervention. vii. Myocardial infarction, myocarditis, or pericarditis ≤ 6 months prior to the first dose of study intervention. viii. Unstable or poorly controlled angina pectoris (including the Prinzmetal variant of angina pectoris) or symptomatic peripheral vascular disease. ix. Poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg).
• Participants with a history of hypertension can be enrolled if the investigator considers that BP is controlled by antihypertensive treatment.
• Participants with clinically significant venous thromboembolism (eg, pulmonary embolism and deep vein thrombosis) within 3 months prior to the first dose of study intervention.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (6)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

deucravacitinib; 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

• Kristine Lacuna, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristine Lacuna, MD

CONTACT

646-888-4321; lacunak@mskcc.org

Dana Rathkopf, MD

CONTACT

646-422-4379; rathkopd@MSKCC.ORG

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 13, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): January 9, 2030
• Study Completion (Estimated): January 9, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (6)