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IOV-3001

Phase 1

Unresectable Melanoma | Monoclonal antibody | Oncology |Iovance Biotherapeutics, Inc.|Last Updated: Dec 3, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06940739A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive LifileucelPHASE1 RECRUITING 42Mar 11, 2025Jul 1, 2032Dec 3, 20254 United States, Australia
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Study Endpoints
Primary Endpoints
Safety and Tolerability
Up to 30 days

The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered

Recommended Dose for Phase 2
Up to 30 days

Determine the recommended dose for Phase 2

Secondary Endpoints
Pharmacokinetics (PK) profile of IOV-3001
Up to 8 days
Pharmacodynamic (PD) Profile of IOV-3001
Up to 8 days
Antidrug Antibody (ADA) Profile
Up to 5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Assigned InterventionsEXPERIMENTALDose escalation participants with unresectable or metastatic melanoma
Interventions
NameTypeDescription
IOV-3001BIOLOGICALIOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Participant must be ≥ 18 years of age at the time of signing the informed consent. 2. Participant has unresectable or metastatic melanoma. 3. Participant has melanoma not of uveal/ocular origin and experienced documented radiographic disease progression during systemic therap...

Countries:United StatesAustralia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06940739primaryCompletionDate: changed
LOWMay 24, 2026NCT06940739studyFirstPostDate: changed