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ABP 206

Phase 3

Melanoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 27, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment889
FDA Designations
No designations recorded
Clinical trial landscape

ABP 206 · 2 trials · 1 indication

Phase 3 2
NCT06054555A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic MelanomaMelanoma
ACTIVE NOT_RECRUITING633 Analytics
NCT05907122A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected MelanomaMelanoma
COMPLETED256 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Melanoma
NCT06054555633
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PHASE3COMPLETED
A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Melanoma
NCT05907122256
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Study Endpoints
Primary Endpoints
Objective response by Week 49
Week 49
Objective response at Week 17
Week 17
Progression-free survival (PFS)
From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)
From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)
From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
Day 1 (Postdose) through Day 28

The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
Week 17 through Week 21

The PK similarity (AUCtau\_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

Secondary Endpoints
Number of subjects with treatment-emergent adverse events
Week 1 until Week 105
Number of subjects with treatment-emergent serious adverse events
Week 1 until Week 105
Number of subjects with treatment-emergent adverse events of interest
Week 1 until Week 105
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABP 206EXPERIMENTALSubjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
NivolumabACTIVE_COMPARATORSubjects will receive Dose A of Nivolumab via IV infusion.
FDA-licensed NivolumabACTIVE_COMPARATORSubjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
EU-authorized NivolumabACTIVE_COMPARATORSubjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
Interventions
NameTypeDescription
ABP 206DRUGABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
NivolumabDRUGNivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.
FDA-licensed NivolumabDRUGFDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
EU-authorized NivolumabDRUGFDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
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Eligibility Criteria
Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites180

Key Inclusion Criteria: * At least 18 years of age. * Histologically confirmed unresectable or metastatic melanoma. * Subject has no prior systemic treatment for advanced disease. * Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). ...

Countries:United StatesArgentinaBosnia and HerzegovinaCanadaChileCroatiaCzechiaEstoniaFranceGeorgiaGermanyItalyJordanLebanonLithuaniaMalaysiaMexicoMoldovaNetherlandsPhilippinesPortugalRomaniaSerbiaSouth AfricaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)UkraineVietnamBrazilJapan
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Competitive Landscape -Melanoma 124 trials

Top 20 of 52 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy
Pfizer Inc.PFE3PHASE3Encorafenib, Binimetinib, Pembrolizumab
Amgen Inc.AMGN1PHASE3ABP 206, Nivolumab
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR3PHASE3Tebentafusp
Aura Biosciences IncAURA4PHASE3Bel-sar
Immatics N.V.IMTX2PHASE3IMA203, nivolumab plus relatlimab, lifileucel, pembrolizumab, ipilimumab
Erasca, Inc.ERAS1PHASE3Naporafenib, Dacarbazine, Temozolomide, Trametinib
Novartis AG Sponsored ADRNVS5PHASE2LXH254, LTT462, Trametinib, Ribociclib
IO Biotech, Inc.IOBT2PHASE3IO102-IO103, Pembrolizumab
AstraZeneca PLCAZN3PHASE2Ceralasertib, Durvalumab
Eikon Therapeutics, Inc.EIKN2PHASE2EIK1001, Pembrolizumab
Moderna, Inc.MRNA1PHASE2mRNA-4157, Pembrolizumab
Genmab A/S Sponsored ADRGMAB2PHASE2Acasunlimab, Pembrolizumab
Agenus Inc.AGEN1PHASE2Botensilimab, Balstilimab
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06054555primaryCompletionDate: changed
LOWMay 24, 2026NCT06054555studyFirstPostDate: changed