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BMS-986218 and Degarelix

Phase 1

Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 7, 2025

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986218 and Degarelix · 1 trial · 1 indication

Early Phase 1 1
NCT04301414Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate CancerProstate Cancer
COMPLETED26 Analytics
EARLY_PHASE1COMPLETED
Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Safety lead-inOTHERThe first 4 subjects enrolled will be given degarelix plus BMS-986218.
Arm AACTIVE_COMPARATORDegarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy
Arm BEXPERIMENTALBMS-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.

Interventions

NameTypeDescription
BMS-986218 and DegarelixDRUGBMS-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.
DegarelixDRUGDegarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 ...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about BMS-986218 and Degarelix

What is BMS-986218 used for in prostate cancer?

BMS-986218 is being studied for use in men with high-risk localized prostate cancer. It is a non-fucosylated anti-CTLA-4 agent being evaluated in combination with degarelix acetate, a hormone therapy, to treat this condition. The drug is currently in early clinical development.

What does BMS-986218 target?

BMS-986218 targets CTLA-4, an immune checkpoint protein. As a non-fucosylated anti-CTLA-4 antibody, it is designed to modulate the immune system's response against cancer cells. This mechanism is being investigated in the context of prostate cancer treatment.

Who makes BMS-986218?

BMS-986218 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this investigational drug for the treatment of prostate cancer.

What phase is BMS-986218 in?

BMS-986218 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What clinical trials is BMS-986218 in?

BMS-986218 is being studied in clinical trial NCT04301414, titled "Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer." This early Phase 1 trial has been completed and enrolled 26 participants in the United States.

Is BMS-986218 the same as degarelix?

No, BMS-986218 is not the same as degarelix. BMS-986218 is an investigational anti-CTLA-4 agent, while degarelix acetate is a separate hormone therapy. In the clinical trial, they are being studied in combination, with BMS-986218 plus degarelix compared against degarelix alone.