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Golcadomide

Phase 3

Large B-cell Lymphoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 12, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment850
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06356129Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell LymphomaPHASE3 ACTIVE NOT_RECRUITING 850Jun 19, 2024Nov 20, 2029Feb 12, 2026325 United States, Argentina +36
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Study Endpoints
Primary Endpoints
Progression-free survival (PFS) assessed by the Investigator
Up to approximately 67 months
Secondary Endpoints
PFS assessed by the Investigator
Up to approximately 67 months
Overall survival (OS)
Up to approximately 67 months
Event-free survival (EFS)
Up to approximately 67 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)EXPERIMENTAL -
Placebo + R-CHOPPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
GolcadomideDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
RituximabDRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
DoxorubicinDRUGSpecified dose on specified days
VincristineDRUGSpecified dose on specified days
PrednisoneDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites325

Inclusion Criteria \- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including: i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including ge...

Countries:United StatesArgentinaAustraliaAustriaBrazilBulgariaCanadaChileChinaColombiaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIndiaItalyJapanMalaysiaMexicoNetherlandsNew ZealandNorwayPolandPortugalPuerto RicoRomaniaSaudi ArabiaSingaporeSlovakiaSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06356129primaryCompletionDate: changed
LOWMay 24, 2026NCT06356129studyFirstPostDate: changed