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BMS-986484

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment213
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06544655A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 213 — — Oct 10, 2024Oct 14, 2027Apr 17, 20269 United States, Australia +1
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs)
Up to approximately 2 years
Incidence of serious adverse events (SAEs)
Up to approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to approximately 28 days
Incidence of AEs leading to discontinuation
Up to approximately 2 years
Incidence of AEs leading to death
Up to approximately 2 years
Secondary Endpoints
Maximum observed concentration (Cmax)
Up to approximately 2 years
Time of maximum observed concentration (Tmax)
Up to approximately 2 years
Area under the concentration-time curve (AUC)
Up to approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: BMS-986484 Dose EscalationEXPERIMENTAL -
Part 1B: BMS-986484 + Nivolumab Dose EscalationEXPERIMENTAL -
Part 2A: BMS-986484 Dose ExpansionEXPERIMENTAL -
Part 2B: BMS-986484 + Nivolumab Dose ExpansionEXPERIMENTAL -
Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose EscalationEXPERIMENTAL -
Part 1 Co-Admin: BMS-986484 + NivolumabEXPERIMENTAL -
Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose EscalationEXPERIMENTAL -
Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986484DRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
OxaliplatinDRUGSpecified dose on specified days
CapecitabineDRUGSpecified dose on specified days
FluorouracilDRUGSpecified dose on specified days
Calcium folinateDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squ...

Countries:United StatesAustraliaCanada
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06544655Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06544655studyFirstPostDate: changed