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EVX-01

Phase 2

Melanoma Stage IV | Small molecule | Oncology |Evaxion A/S|Last Updated: Sep 22, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05309421A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic MelanomaPHASE2 ACTIVE NOT_RECRUITING 17Sep 19, 2022Mar 30, 2026Sep 22, 20254 Australia, Italy
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Study Endpoints
Primary Endpoints
Change in the best overall response (BOR)
Measurements at Baseline through study completion (up to 102 weeks)

Composite of a BOR of complete response (CR) or PR for patients with SD at the time of first EVX-01 administration and a BOR of CR for patients with PR at the time of first EVX-01 administration, within 2 years of treatment with pembrolizumab, as per RECIST 1.1 criteria

Secondary Endpoints
Change in overall response rate
Measurements at Baseline through study completion (up to 102 weeks)
Change in progression free survival (PFS)
Measurements at Baseline through study completion (up to 102 weeks)
Change in overall survival (OS)
Measurements at Baseline through study completion (up to 102 weeks)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EVX-01 in combination with pembrolizumabEXPERIMENTALEVX-01 is administered im. Pembrolizumab is administered according to label
Interventions
NameTypeDescription
EVX-01DRUGInvestigational drug given in combination with standard of care
Pembrolizumab 25 MG/MLDRUGStandard of care
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Be at least 18 years of age on day of signing informed consent. * Histologically confirmed, and not amenable to local therapy, metastatic or unresectable melanoma Stage III or Stage IV, as per AJCC 8th ed. staging system. 1. Patient may not have a diagnosis of uveal or ocul...

Countries:AustraliaItaly
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05309421primaryCompletionDate: changed
LOWMay 24, 2026NCT05309421studyFirstPostDate: changed