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EVX-01

Phase 2

Melanoma Stage IV | Small molecule | Oncology |Evaxion A/S|Last Updated: Sep 22, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

EVX-01 · 1 trial · 2 indications

Phase 2 1
NCT05309421A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic MelanomaMelanoma Stage IV
ACTIVE NOT_RECRUITING17 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma
Melanoma Stage IVUnlock trial analytics

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 to 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

Frequently asked questions about EVX-01

What is EVX-01 used for in melanoma?

EVX-01 is an investigational small molecule being studied for the treatment of Stage IV melanoma, specifically in adults with unresectable or metastatic melanoma. It is currently in Phase 2 clinical development and is being evaluated in combination with pembrolizumab.

Who is developing EVX-01?

EVX-01 is being developed by Evaxion A/S, a biotech company listed on the stock exchange under the ticker EVAX. The company is conducting a Phase 2 clinical trial to evaluate the safety and efficacy of EVX-01 in combination with pembrolizumab in patients with advanced melanoma.

What phase is EVX-01 in?

EVX-01 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and efficacy for treating Stage IV melanoma.

What clinical trials is EVX-01 in?

EVX-01 is being studied in a single Phase 2 clinical trial with the identifier NCT05309421. This trial is evaluating the efficacy and safety of EVX-01 in combination with pembrolizumab in adults with unresectable or metastatic melanoma. The trial is active but not recruiting participants.

How does EVX-01 work?

EVX-01 is a small molecule therapeutic. The specific molecular target or mechanism of action has not been disclosed in available information, so its precise mode of action in treating melanoma is not publicly detailed.