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BMS-986016

Phase 1

Hematologic Neoplasms | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 24, 2023

Target and mechanism

Molecular targetLAG3
Target classInhibitor
ModalityMonoclonal antibody

Also known as Relatlimab, Neoadjuvant relatlimab

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986016 · 1 trial · 1 indication

Phase 1 1
NCT02061761A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell MalignanciesHematologic Neoplasms
COMPLETED106 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies
Hematologic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
From first dose to 100 days post last dose (Up to 51 months)

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
From first dose to 135 days post last dose (Up to 52 months)

Number of participants who died due to any cause.

Number of Participants With On-Treatment Laboratory Abnormalities in Specific Hepatics Tests
From first dose to 30 days post last dose (Up to 49 months)

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

Objective Response Rate (ORR) - Part D
From first dose date to the date of disease progression per investigator or the date of subsequent therapy, whichever occurs first (Up to approximately 95 months)

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.

Duration of Response (DoR) - Part D
From first dose to the date of the first objectively documented progression, or death due to any cause, whichever occurs first (Up to approximately 95 months)

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.

Secondary Endpoints

BMS-986016 Maximum Observed Serum Concentration (Cmax)
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Time of Maximum Observed Serum Concentration (Tmax)
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
BMS-986016 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
PK assessment include the following timepoints: pre-dose, 1, 4, 24, 48, 96, 144, 192 hours end-of-infusion on cycle 1 Day 1, Cycle 3 Day 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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 -

Interventions

NameTypeDescription
BMS-986016BIOLOGICALSpecified Dose on Specified Days
BMS-936558BIOLOGICALSpecified Dose on Specified Days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 ...

Countries:United StatesCanada
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Frequently asked questions about BMS-986016

What is BMS-986012 used for?

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.

What does BMS-986012 target?

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.

Who makes BMS-986012?

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.

What phase is BMS-986012 in?

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.

What clinical trials is BMS-986012 in?

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.

Is BMS-986012 the same as relatlimab?

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.