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Golcadomide

Phase 3

Large B-cell Lymphoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 6, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment850
FDA Designations
No designations recorded
Clinical trial landscape

Golcadomide · 6 trials · 19 indications

Phase 3 2Phase 2 2Phase 1 2
NCT06911502A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)Follicular Lymphoma
RECRUITING400 Analytics
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 LymphomaLarge B-cell Lymphoma
ACTIVE NOT_RECRUITING850 Analytics
PHASE3RECRUITING
A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)
Follicular Lymphoma
NCT06911502400
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PHASE3ACTIVE NOT_RECRUITING
Study 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 Lymphoma
Large B-cell Lymphoma
NCT06356129850
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Study Endpoints
Primary Endpoints
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
Up to approximately 32 Months
Progression-free survival (PFS) assessed by the Investigator
Approximately 24 months after the last participant's first treatment
Proportion of patients who achieve a complete metabolic response in the absence of prohibitive toxicity with induction rituximab, golcadomide with or without nivolumab comprising 8 cycles of therapy with each cycle delivered every 4 weeks.
Consent to 8 weeks after last induction treatment (maximum 44 weeks)

Metabolic response as assessed by PET/CT and defined by Lugano criteria; toxicities as defined by CTCAE v5

Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
Up to approximately 12 months from participant randomization

Golcadomide + Rituximab arms only

Incidence of adverse events
At 30 days post completion of enrollment

Will describe frequency and nature of adverse events associated with CC-99282 + rituximab post CD19 chimeric antigen receptor (CAR) -T cell therapy using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Maximum tolerated dose
At 30 days post completion of enrollment

Will use Bayesian Optimal Interval design to define the maximum tolerated dose.

Maximum observed plasma concentration (Cmax)
Up to Day 67
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to Day 67
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 67
Secondary Endpoints
Overall response rate (ORR) assessed by IRAC
Up to approximately 32 Months
Overall survival (OS)
Up to approximately 83 Months
PFS as assessed by investigator
Up to approximately 32 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Golcadomide + RituximabEXPERIMENTAL -
Rituximab + Lenalidomide/ChemotherapyACTIVE_COMPARATORRituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)EXPERIMENTAL -
Placebo + R-CHOPPLACEBO_COMPARATOR -
Arm A- Golcadomide + RituximabEXPERIMENTALRituximab 375mg/m2 IV infusion Q4W + golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction
Arm B- Nivolumab + golcadomide + RituximabEXPERIMENTALNivolumab 480mg IV infusion Q4W, Rituximab 375mg/m2 IV infusion Q4W and golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction
Rituximab + ChemotherapyEXPERIMENTALR-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Golcadomide Dose 1 + RituximabEXPERIMENTAL -
Golcadomide Dose 2 + RituximabEXPERIMENTAL -
Treatment (rituximab, CC-99282)EXPERIMENTALPatients receive rituximab intravenously (IV) on day 1 of each cycle and CC-99282 orally (PO) once daily (QD) on days 1-14 of each cycle. Treatment repeats every 28 days for up to 6 cycles of rituximab and up to 26 cycles of CC-99282 in the absence of disease progression or unacceptable toxicity. Patients also undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the trial. Patients may undergo biopsy at screening.
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Interventions
NameTypeDescription
GolcadomideDRUGSpecified dose on specified days
RituximabDRUGSpecified dose on specified days
LenalidomideDRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
DoxorubicinDRUGSpecified dose on specified days
VincristineDRUGSpecified dose on specified days
Prednisone/PrednisoloneDRUGSpecified dose on specified days
BendamustineDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
PrednisoneDRUGSpecified dose on specified days
Nivolumab 10 MG/MLDRUGNivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1.
BiopsyPROCEDUREUndergo biopsy
Biospecimen CollectionPROCEDUREUndergo blood sample collection
Computed TomographyPROCEDUREUndergo PET/CT
Positron Emission TomographyPROCEDUREUndergo PET/CT
ItraconazoleDRUGSpecified dose on specified days.
RifampinDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites160

Inclusion Criteria: \- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology ...

Countries:United StatesAustraliaBrazilCanadaChileChinaFinlandFranceGermanyGreeceIndiaItalyJapanNetherlandsPolandSaudi ArabiaSouth KoreaSpainTurkey (Türkiye)United Arab EmiratesUnited KingdomArgentinaAustriaBulgariaColombiaCzechiaDenmarkHungaryMalaysiaMexicoNew ZealandNorwayPortugalPuerto RicoRomaniaSingaporeSlovakiaSwedenTaiwanThailand
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Recent Changes (Last 90 Days)
LOWJul 6, 2026NCT06356129primaryCompletionDate: changed
LOWJul 6, 2026NCT06356129primaryCompletionDate: changed
LOWMay 26, 2026NCT06911502primaryCompletionDate: changed
LOWMay 26, 2026NCT06425302primaryCompletionDate: changed
LOWMay 26, 2026NCT06356129primaryCompletionDate: changed
LOWMay 24, 2026NCT06209619studyFirstPostDate: changed
LOWMay 24, 2026NCT06911502studyFirstPostDate: changed
LOWMay 24, 2026NCT05788081studyFirstPostDate: changed
LOWMay 24, 2026NCT06356129studyFirstPostDate: changed
LOWMay 24, 2026NCT06425302studyFirstPostDate: changed