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BMS-986504

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 25, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986504 · 6 trials · 6 indications

Phase 2 4Phase 1 2
NCT07492680A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)Solid Tumors
RECRUITING260 Analytics
NCT07602946SELECTmeso A Trial for Patients With Relapsed Malignant Mesothelioma SELECTmeso1 A Trial of BMS-986504 in Patients With MTAP-deficient Relapsed MesotheliomaMesothelioma
NOT YET_RECRUITING30 Analytics
NCT07063745A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP DeletionMetastatic Non-small Cell Lung Cancer With MTAP Deletion
RECRUITING590 Analytics
NCT06855771A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)Carcinoma, Non-Small-Cell Lung
RECRUITING130 Analytics
PHASE2RECRUITING
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
NCT07492680260
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PHASE2NOT YET_RECRUITING
SELECTmeso A Trial for Patients With Relapsed Malignant Mesothelioma SELECTmeso1 A Trial of BMS-986504 in Patients With MTAP-deficient Relapsed Mesothelioma
Mesothelioma
NCT0760294630
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PHASE2RECRUITING
A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
Metastatic Non-small Cell Lung Cancer With MTAP Deletion
NCT07063745590
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PHASE2RECRUITING
A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)
Carcinoma, Non-Small-Cell Lung
NCT06855771130
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Study Endpoints

Primary Endpoints

Part 1: Number of participants who achieve Objective Response (OR)
Up to approximately 2 years

OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1

Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Up to approximately 2 years
SELECTmeso Platform : Molecular profiling of participant's tumour block SELECTmeso1: Disease Control Rate (DCR) using RECIST 1.1 at 12 weeks.
SELECTmeso Platform: Baseline SELECTmeso1: at 12 weeks of treatment
Progression-free survival (PFS) by RECIST v1.1
Up to 2 years

Phase 2

PFS by RECIST v1.1 per BICR
Up to 5 years

Phase 3

Overall Survival (OS)
Up to 5 years

Phase 3

Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 3 years after the last participant's last dose of study treatment

OR is defined as confirmed complete response (CR) or partial response (PR)

Maximum Plasma Concentration (Cmax) of BMS-986504
Up to approximately Day 64
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
Up to approximately Day 64
Area Under Curve (AUC) of BMS-986504
Up to approximately Day 64
Mean Elimination Half-life (T-HALF) of BMS-986504
Up to approximately Day 64
Apparent Total Body Clearance (CLT/F) of BMS-986504
Up to approximately Day 64
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504
Up to approximately Day 64
Maximum observed concentration (Cmax)
Up to 2 weeks
Time of maximum observed drug concentration (Tmax)
Up to 2 weeks
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 2 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to 2 weeks
Terminal elimination half-life (T-HALF)
Up to 2 weeks
Apparent total body clearance (CLT/F)
Up to 2 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Up to 2 weeks
Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))
Up to 2 weeks
Blood-to-plasma total radioactivity (TRA) ratio
Up to 2 weeks
Total amount of administered dose recovered in urine (UR)
Up to 2 weeks
Percent of administered dose recovered in urine (%UR)
Up to 2 weeks
Renal clearance (CLR) in urine
Up to 2 weeks
Total radioactivity in UR
Up to 2 weeks
Total radioactivity in %UR
Up to 2 weeks
Total radioactivity in total amount of administered dose recovered in feces (FR)
Up to 2 weeks
Total radioactivity in percent of administered dose recovered in feces (%FR)
Up to 2 weeks
Total amount of radioactivity recovered (Rtotal)
Up to 2 weeks
Total percent of radioactivity recovered (%TOTAL)
Up to 2 weeks
TRA amount recovered and fraction of the radioactive dose in vomit if applicable
Up to 2 weeks

Secondary Endpoints

Part 1 and 2: Time to objective response (TTOR)
Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Up to approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1aEXPERIMENTALBMS-986504
Part 1bEXPERIMENTALBMS-986504
Part 2: Cohort 1EXPERIMENTALBMS-986504 + Pumitamig + Chemotherapy
Part 2: Cohort 2aEXPERIMENTALBMS-986504 + Daraxonrasib
Part 2: Cohort 2bEXPERIMENTALBMS-986504 + Daraxonrasib
Part 2: Cohort 2cEXPERIMENTALBMS-986504 + Daraxonrasib + Chemotherapy
Part 2: Cohort 3EXPERIMENTALBMS-986504 + Nivolumab + Relatlimab FDC
Part 2: Cohort 4EXPERIMENTALBMS-986504 + Temozolomide + Radiotherapy
A phase II trial of BMS-986504 in patients with MTAP-deficient relapsed mesotheliomaEXPERIMENTAL -
Arm A: BMS-986504 + Pembrolizumab + ChemotherapyACTIVE_COMPARATOR -
Arm B: BMS-986504 + Pembrolizumab + ChemotherapyACTIVE_COMPARATOR -
Arm C: Placebo + Pembrolizumab + ChemotherapyPLACEBO_COMPARATOR -
Arm D: Placebo + Pembrolizumab + ChemotherapyPLACEBO_COMPARATOR -
Arm E: BMS-986504 + Pembrolizumab + ChemotherapyACTIVE_COMPARATOR -
Arm F: Placebo + Pembrolizumab + ChemotherapyPLACEBO_COMPARATOR -
Arm A: BMS-986504 Dose 1EXPERIMENTAL -
Arm B: BMS-986504 Dose 2EXPERIMENTAL -
BMS-986504 ArmEXPERIMENTAL -
[14C]-BMS-986504 followed by BMS-986504 MonotherapyEXPERIMENTALPart A: Participants will receive a single oral dose of radiolabeled \[14C\]-BMS-986504 on C1D1. Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met.

Interventions

NameTypeDescription
BMS-986504DRUGSpecified dose on specified days
DaraxonrasibDRUGSpecified dose on specified days
Nivolumab + Relatlimab FDCDRUGSpecified dose on specified days
TemozolomideDRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
PemetrexedDRUGSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
CisplatinDRUGSpecified dose on specified days
[14C]-BMS-986504DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate ...

Countries:United StatesBelgiumCanadaChinaFranceGermanyHong KongIrelandItalyJapanNorwaySouth KoreaSpainUnited KingdomArgentinaAustraliaAustriaBrazilBulgariaChileColombiaCzechiaDenmarkGreeceHungaryIndiaIsraelMalaysiaMexicoNetherlandsPolandRomaniaSwedenTaiwanThailandTurkey (Türkiye)
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Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT07492680lastUpdatePostDate: changed
LOWAug 25, 2026NCT07063745lastUpdatePostDate: changed
LOWAug 25, 2026NCT07492680lastUpdatePostDate: changed
LOWAug 25, 2026NCT07063745lastUpdatePostDate: changed
LOWAug 11, 2026NCT07063745lastUpdatePostDate: changed
LOWAug 11, 2026NCT07063745lastUpdatePostDate: changed
LOWAug 11, 2026NCT07063745lastUpdatePostDate: changed
LOWJul 30, 2026NCT07492680Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 30, 2026NCT07492680Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 20, 2026NCT07063745lastUpdatePostDate: changed
LOWJul 20, 2026NCT07063745lastUpdatePostDate: changed
LOWJul 15, 2026NCT07492680primaryCompletionDate: changed
LOWJul 15, 2026NCT07492680primaryCompletionDate: changed
LOWJun 26, 2026NCT07063745lastUpdatePostDate: changed
LOWJun 26, 2026NCT07063745lastUpdatePostDate: changed
LOWJun 10, 2026NCT06855771lastUpdatePostDate: changed
LOWJun 10, 2026NCT06855771lastUpdatePostDate: changed
MEDIUMJun 8, 2026NCT06672523primaryCompletionDate: changed

Frequently asked questions about BMS-986504

What is BMS-986504 used for?

BMS-986504, also known as navlimetostat, is an investigational small molecule being studied for the treatment of several cancers, including mesothelioma, advanced solid tumors, and non-small cell lung cancer with homozygous MTAP deletion. It is currently in clinical development for these oncology indications.

What does BMS-986504 target?

BMS-986504 is being studied in patients with tumors that have homozygous MTAP deletion, a genetic alteration that may make cancer cells vulnerable to certain treatments. The drug is designed to exploit this vulnerability, though the specific molecular target is not disclosed in the available clinical trial information.

Who is developing BMS-986504?

BMS-986504 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.

What phase is BMS-986504 in?

BMS-986504 is in Phase 1 and Phase 2 clinical trials. Phase 1 trials are assessing safety, tolerability, and drug levels in advanced solid tumors, while Phase 2 trials are evaluating its efficacy in non-small cell lung cancer with MTAP deletion and mesothelioma. It is not yet approved by regulatory authorities.

What clinical trials is BMS-986504 in?

BMS-986504 is being studied in several clinical trials, including NCT06855771 for pre-treated advanced or metastatic non-small cell lung cancer with homozygous MTAP deletion, NCT07063745 for first-line metastatic non-small cell lung cancer with MTAP deletion, NCT07077434 for advanced solid tumors, and NCT07602946 for relapsed malignant mesothelioma.

Is BMS-986504 the same as navlimetostat?

Yes, BMS-986504 is also known as navlimetostat. Clinical trial titles refer to the drug as navlimetostat (BMS-986504), confirming that these names refer to the same investigational agent being developed by Bristol-Myers Squibb.