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AVT32

Phase 1

Melanoma | Monoclonal antibody | Oncology |Alvotech|Last Updated: Aug 24, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as AVT32-DRL_PB

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

AVT32 · 1 trial · 1 indication

Phase 1 1
NCT07475572Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected MelanomaMelanoma
RECRUITING120 Analytics
PHASE1RECRUITING
Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
Melanoma
NCT07475572120
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Study Endpoints

Primary Endpoints

To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Cycle 1 (each cycle is 21 days)

AUC0-3w (Cycle 1)

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVT32-DRL_PBEXPERIMENTALAVT32-DRL\_PB will be administered during double blind period and open label period
KeytrudaACTIVE_COMPARATORKeytruda will be administered during double blind period

Interventions

NameTypeDescription
AVT32-DRL_PBBIOLOGICALAVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.
KeytrudaBIOLOGICALKeytruda at a dose 200 mg administered intravenously every 3 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participants (male/female) ≥18 years of age at the time of signing the ICF. * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment. * Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma ...

Countries:Ukraine
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Competitive Landscape -Melanoma 122 trials

Top 20 of 50 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib
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)

LOWAug 24, 2026NCT07475572Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07475572Status: NOT_YET_RECRUITING → RECRUITING