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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 ...
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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.
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.
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.
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.
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.
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.