A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma
NCT05309421 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2025-09-22
Summary
The purpose of this single arm, multi-national clinical trial in patients with metastatic or unresectable melanoma is to evaluate the BOR and compare it to historical data on patients on anti-PD1 treatment with pembrolizumab alone.
Conditions
- Melanoma Stage IV
- Unresectable Melanoma
Interventions
- DRUG
-
EVX-01
Investigational drug given in combination with standard of care
- DRUG
-
Pembrolizumab 25 MG/ML
Standard of care
Sponsors & Collaborators
- collaborator INDUSTRY
-
Evaxion Biotech A/S
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-19
- Primary Completion
- 2025-09-30
- Completion
- 2026-03-30
- FDA Drug
- Yes
Countries
- Australia
- Italy
Study Locations
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