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NCT03400332

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Completed Phase 1, PHASE2 Results posted Last updated 24 February 2026
What this trial tests

Phase 1, PHASE2 trial testing BMS-986253 in Cancer in 281 participants. Completed in 4 December 2025.

Timeline
12 February 2018
Primary endpoint
26 April 2024
4 December 2025

Quick facts

Lead sponsorBristol-Myers Squibb
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment281
Start date12 February 2018
Primary completion26 April 2024
Estimated completion4 December 2025
Sites72 locations across France, Italy, Belgium, Sweden, United Kingdom, Germany, Poland, Canada

Drugs / interventions tested

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Cancer or Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Experiencing Adverse Events (AEs) - Part 1 Primary · 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 a

GroupValue95% CI
Part 1: 600 Q4W16
Part 1: 1200 Q4W14
Part 1: 2400 Q4W18
Part 1: 1200 Q2W12
Part 1: 2400 Q2W60
Part 1: 3600 Q2W20
Part 1: 3600Q2W + Nivo + Ipi15
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1 Primary · 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.

GroupValue95% CI
Part 1: 600 Q4W13
Part 1: 1200 Q4W10
Part 1: 2400 Q4W13
Part 1: 1200 Q2W7
Part 1: 2400 Q2W31
Part 1: 3600 Q2W12
Part 1: 3600Q2W + Nivo + Ipi9
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1 Primary · 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.

GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W0
Part 1: 2400 Q4W0
Part 1: 1200 Q2W0
Part 1: 2400 Q2W0
Part 1: 3600 Q2W0
Part 1: 3600Q2W + Nivo + Ipi0
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1 Primary · 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.

GroupValue95% CI
Part 1: 600 Q4W3
Part 1: 1200 Q4W2
Part 1: 2400 Q4W3
Part 1: 1200 Q2W3
Part 1: 2400 Q2W7
Part 1: 3600 Q2W1
Part 1: 3600Q2W + Nivo + Ipi3
Number of Participants Who Died - Part 1 Primary · 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.

GroupValue95% CI
Part 1: 600 Q4W14
Part 1: 1200 Q4W15
Part 1: 2400 Q4W17
Part 1: 1200 Q2W10
Part 1: 2400 Q2W53
Part 1: 3600 Q2W13
Part 1: 3600Q2W + Nivo + Ipi8
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1 Primary · 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.

Hemoglobin - Grade 3
GroupValue95% CI
Part 1: 600 Q4W2
Part 1: 1200 Q4W1
Part 1: 2400 Q4W2
Part 1: 1200 Q2W2
Part 1: 2400 Q2W7
Part 1: 3600 Q2W3
Part 1: 3600Q2W + Nivo + Ipi3
Alanine aminotransferase - Grade 3
GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W1
Part 1: 2400 Q4W0
Part 1: 1200 Q2W0
Part 1: 2400 Q2W0
Part 1: 3600 Q2W0
Part 1: 3600Q2W + Nivo + Ipi2
Alkaline phosphatase - Grade 3
GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W0
Part 1: 2400 Q4W2
Part 1: 1200 Q2W0
Part 1: 2400 Q2W2
Part 1: 3600 Q2W3
Part 1: 3600Q2W + Nivo + Ipi2
Aspartate aminotransferase - Grade 3
GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W1
Part 1: 2400 Q4W0
Part 1: 1200 Q2W0
Part 1: 2400 Q2W0
Part 1: 3600 Q2W2
Part 1: 3600Q2W + Nivo + Ipi1
Phosphate - Grade 3
GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W1
Part 1: 2400 Q4W2
Part 1: 1200 Q2W0
Part 1: 2400 Q2W3
Part 1: 3600 Q2W1
Part 1: 3600Q2W + Nivo + Ipi0
Sodium - Grade 3
GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W2
Part 1: 2400 Q4W1
Part 1: 1200 Q2W0
Part 1: 2400 Q2W5
Part 1: 3600 Q2W1
Part 1: 3600Q2W + Nivo + Ipi2
Lipase - Grade 3
GroupValue95% CI
Part 1: 600 Q4W1
Part 1: 1200 Q4W1
Part 1: 2400 Q4W2
Part 1: 1200 Q2W1
Part 1: 2400 Q2W3
Part 1: 3600 Q2W0
Part 1: 3600Q2W + Nivo + Ipi2
Lipase - Grade 4
GroupValue95% CI
Part 1: 600 Q4W0
Part 1: 1200 Q4W0
Part 1: 2400 Q4W0
Part 1: 1200 Q2W1
Part 1: 2400 Q2W2
Part 1: 3600 Q2W0
Part 1: 3600Q2W + Nivo + Ipi2
Objective Response Rate (ORR) - Part 1 Secondary · 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)

Objective Response Rate per investigator 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

GroupValue95% CI
Part 1: 600 Q4W6.30.2 – 30.2
Part 1: 1200 Q4W6.70.2 – 31.9
Part 1: 2400 Q4W16.73.6 – 41.4
Part 1: 1200 Q2W00.0 – 26.5
Part 1: 2400 Q2W3.20.4 – 11.0
Part 1: 3600 Q2W10.01.2 – 31.7
Part 1: 3600Q2W + Nivo + Ipi13.31.7 – 40.5
Duration of Response (DOR) - Part 1 Secondary · 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)

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis computed using Kaplan-Meier method. Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameter

GroupValue95% CI
Part 1: 600 Q4W3.73.7 – 3.7
Part 1: 1200 Q4W28.928.9 – 28.9
Part 1: 2400 Q4W44.68.4 – 44.6
Part 1: 2400 Q2W21.094.0 – 21.1
Part 1: 3600 Q2W3.43.4 – 3.4
Part 1: 3600Q2W + Nivo + IpiNA3.7 – 24.0
Maximum Concentration (Cmax) - Part 1 Secondary · Cycle 1 Day 1

Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose. 1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

GroupValue95% CI
Part 1: 600 Q4W142.91± 52.1
Part 1: 1200 Q4W352.12± 62.7
Part 1: 2400 Q4W779.90± 43.1
Part 1: 1200 Q2W325.67± 24.0
Part 1: 2400 Q2W919.44± 32.8
Part 1: 3600 Q2W1227.67± 23.3
Part 1: 3600Q2W + Nivo + Ipi999.60± 29.4
AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1 Secondary · 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1

AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. 1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

GroupValue95% CI
Part 1: 600 Q4W19594.22± 52.7
Part 1: 1200 Q4W44821.39± 44.5
Part 1: 2400 Q4W105171.46± 29.7
Part 1: 1200 Q2W42835.41± 28.1
Part 1: 2400 Q2W112123.35± 34.2
Part 1: 3600 Q2W148321.77± 32.0
Part 1: 3600Q2W + Nivo + Ipi118041.10± 40.3
AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1 Secondary · Cycle 1 Day 1

Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. 1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)

GroupValue95% CI
Part 1: 600 Q4W21301.74± 49.5
Part 1: 1200 Q4W48664.06± 42.9
Part 1: 2400 Q4W106916.11± 27.3
Part 1: 1200 Q2W43844.97± 24.8
Part 1: 2400 Q2W113969.47± 30.8
Part 1: 3600 Q2W153791.84± 27.9
Part 1: 3600Q2W + Nivo + Ipi137809.44± 29.5
Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1 Secondary · Cycle 1 Day 1

BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. 1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group

GroupValue95% CI
Part 1: 600 Q4W6.81± 173.8
Part 1: 1200 Q4W14.92± 144.4
Part 1: 2400 Q4W23.68± 692.4
Part 1: 1200 Q2W55.82± 53.0
Part 1: 2400 Q2W141.89± 42.6
Part 1: 3600 Q2W181.84± 46.3
Part 1: 3600Q2W + Nivo + Ipi175.29± 46.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: 600 Q4W
Serious: 13/16 (81%)
Deaths: 14/16
Part 1: 1200 Q4W
Serious: 10/15 (67%)
Deaths: 15/15
Part 1: 2400 Q4W
Serious: 13/18 (72%)
Deaths: 17/18
Part 1: 1200 Q2W
Serious: 7/12 (58%)
Deaths: 10/12
Part 1: 2400 Q2W
Serious: 31/63 (49%)
Deaths: 53/63
Part 1: 3600 Q2W
Serious: 12/20 (60%)
Deaths: 13/20
Part 1: 3600Q2W + Nivo + Ipi
Serious: 9/15 (60%)
Deaths: 8/15
Part 2 Arm A: BMS+Nivo+Ipi
Serious: 44/62 (71%)
Deaths: 30/62
Part 2 Arm B: Placebo+Nivo+Ipi
Serious: 42/57 (74%)
Deaths: 17/60

Serious adverse events (146 terms)

ReactionSystemPart 1: 600 Q4WPart 1: 1200 Q4WPart 1: 2400 Q4WPart 1: 1200 Q2WPart 1: 2400 Q2WPart 1: 3600 Q2WPart 1: 3600Q2W + Nivo + IpiPart 2 Arm A: BMS+Nivo+IpiPart 2 Arm B: Placebo+Nivo…
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)
ColitisGastrointestinal disorders
PneumoniaInfections and infestations
HyponatraemiaMetabolism and nutrition disorders
DiarrhoeaGastrointestinal disorders
DeathGeneral disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
PyrexiaGeneral disorders
Haemophagocytic lymphohistiocytosisImmune system disorders
Urinary tract infectionInfections and infestations
Alanine aminotransferase increasedInvestigations
AnaemiaBlood and lymphatic system disorders
DysphagiaGastrointestinal disorders
AstheniaGeneral disorders
FatigueGeneral disorders
General physical health deteriorationGeneral disorders
CholecystitisHepatobiliary disorders
Aspartate aminotransferase increasedInvestigations
HypercalcaemiaMetabolism and nutrition disorders
HaemoptysisRespiratory, thoracic and mediastinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
Febrile neutropeniaBlood and lymphatic system disorders
PancytopeniaBlood and lymphatic system disorders
Acute coronary syndromeCardiac disorders
Other adverse events (267 terms — click to expand)

ReactionSystemPart 1: 600 Q4WPart 1: 1200 Q4WPart 1: 2400 Q4WPart 1: 1200 Q2WPart 1: 2400 Q2WPart 1: 3600 Q2WPart 1: 3600Q2W + Nivo + IpiPart 2 Arm A: BMS+Nivo+IpiPart 2 Arm B: Placebo+Nivo…
DiarrhoeaGastrointestinal disorders
FatigueGeneral disorders
PyrexiaGeneral disorders
AnaemiaBlood and lymphatic system disorders
Decreased appetiteMetabolism and nutrition disorders
NauseaGastrointestinal disorders
AstheniaGeneral disorders
Alanine aminotransferase increasedInvestigations
PruritusSkin and subcutaneous tissue disorders
Aspartate aminotransferase increasedInvestigations
ConstipationGastrointestinal disorders
HyperglycaemiaMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Gamma-glutamyltransferase increasedInvestigations
Lipase increasedInvestigations
HeadacheNervous system disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
Abdominal painGastrointestinal disorders
VomitingGastrointestinal disorders
Oedema peripheralGeneral disorders
Blood lactate dehydrogenase increasedInvestigations
InsomniaPsychiatric disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
LymphopeniaBlood and lymphatic system disorders
Amylase increasedInvestigations
Protein total decreasedInvestigations
HypocalcaemiaMetabolism and nutrition disorders
HyponatraemiaMetabolism and nutrition disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Urinary tract infectionInfections and infestations
Blood albumin decreasedInvestigations
Weight decreasedInvestigations
HypercalcaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Abdominal pain upperGastrointestinal disorders
ColitisGastrointestinal disorders
Blood bilirubin increasedInvestigations

Most-reported serious reactions: Malignant neoplasm progression, Colitis, Pneumonia, Hyponatraemia, Diarrhoea, Death, Dyspnoea, Pyrexia.

Data from ClinicalTrials.gov NCT03400332 adverse events section.

Sponsor's own description

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cytokines in clinical cancer immunotherapy.
    Berraondo P, Sanmamed MF, Ochoa MC, Etxeberria I, et al · · 2019 · cited 834× · PMID 30413827 · DOI 10.1038/s41416-018-0328-y
  2. Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
    Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
  3. Interleukins in cancer: from biology to therapy.
    Briukhovetska D, Dörr J, Endres S, Libby P, et al · · 2021 · cited 587× · PMID 34083781 · DOI 10.1038/s41568-021-00363-z
  4. Elevated serum interleukin-8 is associated with enhanced intratumor neutrophils and reduced clinical benefit of immune-checkpoint inhibitors.
    Schalper KA, Carleton M, Zhou M, Chen T, et al · · 2020 · cited 429× · PMID 32405062 · DOI 10.1038/s41591-020-0856-x
  5. Next generation of immune checkpoint inhibitors and beyond.
    Marin-Acevedo JA, Kimbrough EO, Lou Y. · · 2021 · cited 401× · PMID 33741032 · DOI 10.1186/s13045-021-01056-8
  6. The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
    Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
  7. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
    Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
  8. Interleukin-8: A chemokine at the intersection of cancer plasticity, angiogenesis, and immune suppression.
    Fousek K, Horn LA, Palena C. · · 2021 · cited 278× · PMID 32980444 · DOI 10.1016/j.pharmthera.2020.107692

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