Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986249 · 1 trial · 1 indication
Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.
Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Number of Participants who Died
Number of Participants with Shifts from Baseline in Laboratory Tests
Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.
Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Part 1A: BMS-986249 | EXPERIMENTAL | - |
| Part 1B: BMS-986249 + nivolumab (nivo) | EXPERIMENTAL | - |
| Part 2A Arm C: BMS-986249 + nivo | EXPERIMENTAL | Previously untreated unresectable stage III-IV melanoma |
| Part 2A Arm D: ipilimumab + nivo then nivo | EXPERIMENTAL | Previously untreated unresectable stage III-IV melanoma |
| Part 2A Arm F: BMS-986249 + nivo | EXPERIMENTAL | Previously untreated unresectable stage III-IV melanoma |
| Part 2B Cohort 1: BMS-986249 + nivo | EXPERIMENTAL | Advanced or intermediate hepatocellular carcinoma (HCC) |
| Part 2B Cohort 2: BMS-986249 + nivo | EXPERIMENTAL | Metastatic castration-resistant prostate cancer (CRPC) |
| Part 2B Cohort 3: BMS-986249 + nivo | EXPERIMENTAL | Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) |
| Part 2A Arm A: BMS-986249 + nivo then nivo | EXPERIMENTAL | * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm |
| Part 2A Arm B: BMS-986249 + nivo | EXPERIMENTAL | * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm |
| Part 2A Arm E: Nivo | EXPERIMENTAL | * Previously untreated unresectable stage III-IV melanoma * Enrollment is closed for this Arm |
| Name | Type | Description |
|---|---|---|
| BMS-986249 | BIOLOGICAL | Specified dose on specified days |
| Nivolumab | BIOLOGICAL | Specified dose on specified days |
| Ipilimumab | BIOLOGICAL | Specified dose on specified days |
Inclusion Criteria: * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cance...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
BMS-986249 is an investigational monoclonal antibody being developed for the treatment of advanced cancer. It is currently in Phase 1 clinical development, and it has been studied alone and in combination with nivolumab in patients with advanced solid tumors.
BMS-986249 is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody in patients with advanced cancer.
BMS-986249 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 in clinical trials. One Phase 1 trial has been completed, with a total enrollment of 356 participants.
BMS-986249 has been studied in one clinical trial, identified as NCT03369223. This Phase 1 trial evaluated BMS-986249 alone and in combination with nivolumab in advanced solid tumors. The trial was completed and enrolled 356 participants across multiple countries, including the United States, Argentina, Australia, and Canada.
No, BMS-986249 is not the same as nivolumab. BMS-986249 is a distinct investigational monoclonal antibody being studied alone and in combination with nivolumab in a clinical trial for advanced solid tumors. Nivolumab is a separate drug that is also developed by Bristol-Myers Squibb.