Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986218 and Degarelix · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Safety lead-in | OTHER | The first 4 subjects enrolled will be given degarelix plus BMS-986218. |
| Arm A | ACTIVE_COMPARATOR | Degarelix 240mg subcutaneous (SQ) x1 dose 2 weeks prior to radical prostatectomy |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Degarelix | DRUG | Degarelix 240mg SQ x1 dose 2 weeks prior to radical prostatectomy |
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 ...
Top 20 of 55 competitors
BMS-986218 plus degarelix is being studied for high-risk localized prostate cancer. The combination pairs an investigational anti-CTLA-4 antibody with degarelix acetate, a hormone therapy that lowers testosterone. It is not approved and remains in clinical development.
BMS-986218 targets CTLA-4, an immune checkpoint receptor on T cells. It is a non-fucosylated anti-CTLA-4 antibody designed to enhance immune responses against tumor cells. Bristol-Myers Squibb is developing it in combination with degarelix acetate for prostate cancer.
Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is developing BMS-986218 in combination with degarelix acetate. The company sponsored the clinical trial evaluating this combination in men with high-risk localized prostate cancer.
The combination of BMS-986218 and degarelix acetate is in Phase 1 development. The single trial was conducted as an early Phase 1 study. BMS-986218 is investigational and has not been approved by the FDA for any indication.
BMS-986218 plus degarelix acetate was evaluated in one completed trial, NCT04301414, titled Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer. It enrolled 26 male participants aged 18 and older in the United States.
NCT04301414 was a randomized, active-controlled early Phase 1 trial comparing BMS-986218 plus degarelix acetate against degarelix acetate alone. It was not double-blinded, enrolled 26 men with high-risk localized prostate cancer, and has been completed.