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BMS-986213

Phase 2

Gastric Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 3, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment274

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986213 · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT03662659An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) CancersGastric Cancer
COMPLETED274 Analytics
PHASE2COMPLETED
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
Up to 25 months

The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection
From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

Number of Participants with Adverse Events (AEs)
Approximately 3 years
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Approximately 3 years
Number of Deaths
Approximately 3 years
Number of Participants with AEs Leading to Discontinuation
Approximately 3 years
Number of Participants with Laboratory Abnormalities
Approximately 3 years
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Approximately 3 years
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Approximately 3 years
Trough Observed Plasma Concentration (Ctrough) of Relatlimab
Approximately 3 years
Concentration of Relatlimab at the end of a dosing interval (Ctau)
Approximately 3 years
Average concentration of Relatlimab over a dosing interval (Cavg(TAU))
Approximately 3 years
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab
Approximately 3 years
Total Body Clearance (CLT) of Relatlimab
Approximately 3 years
Observed Concentration of Relatlimab at End of Infusion (Ceoi)
Approximately 3 years

Secondary Endpoints

Objective Response Rate (ORR)
From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
Duration of Response (DOR)
From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
Overall Survival (OS)
From the date of randomization to the date of death due to any cause (Up to 63 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986213 + investigator's choice chemotherapyEXPERIMENTALBMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
Nivolumab + investigator's choice chemotherapyEXPERIMENTALNivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
Cohort A: BMS-986213 Fixed Dose CombinationEXPERIMENTAL -
Cohort B: BMS-986213 Fixed Dose CombinationEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986213BIOLOGICALRelatlimab + Nivolumab specified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
XELOXDRUGOxaliplatin + capecitabine
FOLFOXDRUGOxaliplatin + leucovorin + fluorouracil
SOXDRUGOxaliplatin + tegafur/gimeracil/oteracil potassium
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites79

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Histologically- or cytologically-confirmed diagnosis of unresectable and eithe...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaChileCzechiaFranceGermanyItalyNorwayPolandPuerto RicoSingaporeSpainUnited KingdomChina
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Competitive Landscape -Gastric Cancer 112 trials

Top 20 of 45 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab, paclitaxel, Paclitaxel, Docetaxel
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY6PHASE2Pumitamig, Folfox, Capox, Nivolumab
Pfizer Inc.PFE7PHASE2disitamab vedotin, tucatinib
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography/Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106- Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed/m2, Cisplatin/m2
Incyte CorporationINCY1PHASE2Capecitabine, Oxaliplatin, Retifanlimab
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
Enliven Therapeutics, Inc.ELVN1PHASE1ELVN-002, Trastuzumab, 5-Fluorouracil, Oxaliplatin, Capecitabine
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Frequently asked questions about BMS-986213

What is BMS-986213 used for?

BMS-986213 is an investigational small molecule being studied for the treatment of gastric cancer and advanced solid tumors. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does BMS-986213 target?

BMS-986213 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated in combination with chemotherapy for gastric or gastroesophageal junction cancers and in a fixed-dose combination with relatlimab and nivolumab for advanced solid tumors.

Who makes BMS-986213?

BMS-986213 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.

What phase is BMS-986213 in?

BMS-986213 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy.

What clinical trials is BMS-986213 in?

BMS-986213 has been studied in two completed clinical trials. NCT03662659 was a Phase 2 study of immunotherapy combinations with chemotherapy in gastric or gastroesophageal junction cancers, enrolling 274 participants. NCT05134948 was a Phase 1 study of relatlimab and nivolumab fixed-dose combination in Chinese participants with advanced solid tumors, enrolling 24 participants.

Is BMS-986213 the same as relatlimab and nivolumab?

BMS-986213 is not the same as relatlimab and nivolumab. It is a separate investigational small molecule. However, it has been studied in combination with relatlimab and nivolumab as a fixed-dose combination in a clinical trial for advanced solid tumors.