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BMS-986253

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 24, 2026

Target and mechanism

Molecular targetIL-8
Target classCytokine
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment281

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986253 · 1 trial · 2 indications

Phase 1 1
NCT03400332A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced CancersCancer
COMPLETED281 Analytics
PHASE1COMPLETED
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Adverse Events (AEs) - Part 1
From first dose up to 100 days after last dose (up to 65 months)

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. This endpoint was prespecified in the protocol to include only participants in Part 1.

Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1
From first dose up to 100 days after last dose (up to 65 months)

A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. This endpoint was prespecified in the protocol to include only participants in Part 1.

Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1
From first dose up to 100 days after last dose (up to 65 months)

Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs. This endpoint was prespecified in the protocol to include only participants in Part 1.

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1
From first dose up to 100 days after last dose (up to 65 months)

Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. This endpoint was prespecified in the protocol to include only participants in Part 1.

Number of Participants Who Died - Part 1
From first dose up to 100 days after last dose (up to 65 months)

The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.

Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1
From first dose up to 30 days after last dose (up to 63 months)

Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. This endpoint was prespecified in the protocol to include only participants in Part 1.

Objective Response Rate (ORR) - Part 2
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)

Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.

Secondary Endpoints

Objective Response Rate (ORR) - Part 1
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Duration of Response (DOR) - Part 1
From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Maximum Concentration (Cmax) - Part 1
Cycle 1 Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: BMS-986253 + nivolumabEXPERIMENTAL -
Part 1B: BMS-986253 + nivolumabEXPERIMENTAL -
Part 1C: BMS-986253 + nivolumab + ipilimumabEXPERIMENTAL -
Part 2A: BMS-986253 + nivolumab + ipilimumabEXPERIMENTAL -
Part 2B: Placebo + nivolumab + ipilimumabPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-986253DRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
IpilimumabBIOLOGICALSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites72

Inclusion Criteria: * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 * At least 1 lesion accessible for biopsy * Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Cri...

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyItalyPolandSpainSwedenSwitzerlandUnited Kingdom
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Frequently asked questions about BMS-986253

What is BMS-986253 used for?

BMS-986253 is an investigational small molecule being developed for the treatment of cancer. It is being studied in combination with other therapies for advanced cancers, including melanoma. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does BMS-986253 target?

BMS-986253 targets IL-8, a cytokine involved in inflammatory and tumor-promoting processes. By inhibiting IL-8, the drug aims to modulate the tumor microenvironment and potentially enhance the anti-tumor immune response when used in combination with other cancer immunotherapies.

Who makes BMS-986253?

BMS-986253 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company. Bristol-Myers Squibb is publicly traded on the New York Stock Exchange under the ticker symbol BMY.

What phase is BMS-986253 in?

BMS-986253 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being evaluated for safety, tolerability, and preliminary efficacy in patients with advanced cancers.

What clinical trials is BMS-986253 in?

BMS-986253 has been studied in one completed Phase 1 clinical trial, identified as NCT03400332. This trial evaluated BMS-986253 in combination with nivolumab or nivolumab plus ipilimumab in patients with advanced cancers, including melanoma. The trial enrolled 281 participants across multiple countries.

Is BMS-986253 the same as other drugs?

BMS-986253 is a unique investigational compound developed by Bristol-Myers Squibb. It is not known to be the same as any other marketed drug. Its mechanism of action, targeting IL-8, distinguishes it from other cancer therapies, and it is being studied specifically in combination with checkpoint inhibitors.