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Prostate CancerPhase 2NCT07335796

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

A Phase 2 study testing BMS-986165 and Degarelix in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
BMS-986165 and Degarelix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
6 sitesUnited States
Study dates
9 Jan 2026to 9 Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • 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.
  • Participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, 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. v) Participants must refrain from donating sperm 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. vi) Breastfeeding partners of participants should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms.
  • See Appendix B for further guidelines and definitions.

Who cannot join

  • 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.
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  • 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:
  • 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.
  • Active viral hepatitis, including the following:
  • Any positive test result for HBV indicating presence of virus, eg, HBV DNA positive would be excluded. Participants with anti-HBs positive in line with prior vaccination are eligible to enroll. ii. Any positive test result for HCV indicating presence of active viral replication (detectable HCV-RNA). iii. Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll.
  • Known HIV positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if: i. Participant has received ART for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled on study and an HIV viral load less than 400 copies/mL prior to enrollment. ii. Participant continues on ART as clinically indicated while enrolled on study.
  • In the case ART is at risk of drug-drug interaction, participants should be switched to an alternate effective ART regimen (with minimal drug-drug interaction potential) before study participation or should be excluded from the study if their regimen cannot be altered. iv. CD4 counts and viral load are monitored per standard of care by a local health care provider.
  • Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for basal or squamous cell skin cancer or superficial bladder cancer that has previously been treated.
  • Use of any prohibited concomitant medications including herbal supplements (Section 10.4) within 2 weeks prior to treatment start
  • Receiving any other investigational agents within 4 weeks or 5x the half-life of investigational agent (whichever is longer) from this study's treatment start
  • Known allergy to any of the compounds under investigation
  • Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New York, 11553

Other trials in United States

About this study

Official title: A Phase 2 Study of Androgen Deprivation Therapy and BMS986365 in High-Risk Localized Prostate Cancer Patients Prior to Radical Prostatectomy

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
Being tested
BMS-986165, Degarelix
Keywords
Prostate Cancer, Memorial Sloan Kettering Cancer Center, 25-262
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986165Drug

    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)

  • DegarelixDrug

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

Study groups in NCT07335796
Study groupRoleWhat they receive
Participants with high-risk localized prostate cancerExperimentalEligible 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.
Receives: Drug: BMS-986165; Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  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) .

    Measured: 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start9 Jan 2026
  3. Primary completion9 Jan 2030 (estimated)
  4. Study completion9 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07335796
Sponsor's protocol ID
25-262
Status last verified
Oct 2026
First submitted
9 Jan 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986165 and Degarelix in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of pathologic complete response/pCR (time frame: 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07335796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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