Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Relatlimab, Neoadjuvant relatlimab
BMS-986016 · 1 trial · 1 indication
Number of participants with any grade adverse events (AEs), any grade serious adverse events (SAEs) and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of participants who died due to any cause.
Number of participants with laboratory abnormalities in specific hepatic tests based on SI unit convention. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Investigator-assessed ORR per International Working Group (IWG 2007) response criteria for malignant lymphoma is defined as the number of participants with a best overall documented response (BOR) of either a complete response (CR) or partial response (PR). Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. \>= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions). Progressive disease: Any new lesion or increase by \>=50% of previously involved sites from nadir.
Investigator-assessed DoR per International Working Group (IWG 2007)) response criteria for malignant lymphoma is defined as the time between the date of first documented response (complete response or partial response) to the date of the first objectively documented progression, or death due to any cause, whichever occurs first. Complete response: Disappearance of all evidence of disease. Partial response: Regression of measurable disease and no new sites. \>= 50% decrease in sum of the produce of the diameters of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions). Progressive disease: Any new lesion or increase by \>=50% of previously involved sites from nadir.
| Arm | Type | Description |
|---|---|---|
| Part A - relatlimab (Dose escalation) | EXPERIMENTAL | - |
| Part C - relatlimab + nivolumab (Dose escalation) | EXPERIMENTAL | - |
| Part B - relatlimab (Cohort expansion) | EXPERIMENTAL | - |
| Part D - relatlimab + nivolumab (Cohort expansion) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986016 | BIOLOGICAL | Specified Dose on Specified Days |
| BMS-936558 | BIOLOGICAL | Specified Dose on Specified Days |
Inclusion Criteria: * Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment * Must have progressed or been refractory to, at least ...
BMS-986012 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors, melanoma, extensive-stage small cell lung cancer, hepatocellular carcinoma, and other cancers. It is currently in Phase 2 clinical development for these oncology indications.
BMS-986012 is a monoclonal antibody, classified under the -mab (antibody) target class. It is being evaluated in combination with other therapies for the treatment of small cell lung cancer and other solid tumors.
BMS-986012 is being developed by Bristol-Myers Squibb Company, traded on the stock exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
BMS-986012 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of advanced solid tumors, melanoma, extensive-stage small cell lung cancer, and hepatocellular carcinoma.
BMS-986012 has been studied in several clinical trials, including NCT02247349, NCT02815592, NCT02949895, and NCT05498480. These trials have evaluated the drug in small cell lung cancer and advanced solid tumors, with some studies completed and others ongoing.
Yes, BMS-986012 is also known as relatlimab. It is being studied in combination with nivolumab, and the fixed-dose combination of relatlimab and nivolumab is also referred to as BMS-986016. The drug is being evaluated for the treatment of various cancers.