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CC 5013

Phase 3

Melanoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 8, 2019

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment548
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00057616Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.PHASE3 COMPLETED 274Oct 1, 2002Jul 15, 2005Nov 8, 201949 Australia, Estonia +7
NCT00055562Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant MelanomaPHASE2 COMPLETED 274Jan 1, 2003Dec 1, 2004Jun 24, 200531 United States, Canada
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
CC-5013DRUG -
CC 5013DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites49

* Understand and voluntarily sign an informed consent form * Able to adhere to the study visit schedule and other protocol requirements * Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy * Women of childbearing potential must have a negative serum or ...

Countries:AustraliaEstoniaGermanyLatviaLithuaniaNetherlandsSouth AfricaUkraineUnited KingdomUnited StatesCanada
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Competitive Landscape -Melanoma 127 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab, pembrolizumab, Pembrolizumab Berahyaluronidase alfa
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab, Nivolumab + Relatlimab, rHuPH20, Relatlimab, relatlimab+nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab, fianlimab, cemiplimab
Pfizer Inc.PFE4PHASE3Encorafenib, Binimetinib, Pembrolizumab, PF-08046049, PF-07799933
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib, IDE196, Crizotinib, Pembrolizumab, Ipilimumab
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period, Lifileucel, LN-145/LN-144, Cyclophosphamide
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy, RP1
Amgen Inc.AMGN1PHASE3ABP 206, Nivolumab
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR3PHASE3Tebentafusp, Brenetafusp, Nivolumab
Immatics N.V.IMTX2PHASE3IMA203, nivolumab plus relatlimab, lifileucel, pembrolizumab, ipilimumab
Aura Biosciences IncAURA4PHASE3Bel-sar
Novartis AG Sponsored ADRNVS6PHASE2LXH254, LTT462, Trametinib, Ribociclib, DYP688
IO Biotech, Inc.IOBT2PHASE3IO102-IO103, Pembrolizumab, Pembrolizumab KEYTRUDA
Erasca, Inc.ERAS1PHASE3Naporafenib, Dacarbazine, Temozolomide, Trametinib
AstraZeneca PLCAZN3PHASE2Ceralasertib, Durvalumab, AZD6750, rilvegostomig, Trastuzumab deruxtecan
Eikon Therapeutics, Inc.EIKN2PHASE2EIK1001, Pembrolizumab, Association atezolizumab + BDB001 + RT
Moderna, Inc.MRNA1PHASE2mRNA-4157, Pembrolizumab
Genmab A/S Sponsored ADRGMAB2PHASE2Acasunlimab, Pembrolizumab, GEN1042, Cisplatin, Carboplatin
Agenus Inc.AGEN1PHASE2Botensilimab, Balstilimab
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
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