NCT05309421

A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

An Open Label, Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Checkpoint Inhibitor Treatment naïve Adults With Unresectable or Metastatic Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Evaxion Biotech A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will initiate treatment with pembrolizumab at the start of the trial and receive up to 18 treatment cycles (approximately 2 years). Immunization with the EVX-01 will be initiated at Week 12. In total, 10 doses of EVX-01 will be administered intramuscularly, with 6 doses given two weeks apart and 4 booster doses at later time points.

Conditions

• Melanoma Stage IV
• Unresectable Melanoma

Interventions

Type	Name	Description
DRUG	EVX-01	Investigational drug given in combination with standard of care
DRUG	Pembrolizumab 25 MG/ML	Standard of care

Timeline

• Start date: 2022-09-19
• Primary completion: 2025-09-30
• Completion: 2026-03-30
• First posted: 2022-04-04
• Last updated: 2025-09-22

Locations

4 sites across 2 countries: Australia, Italy

Regulatory

• FDA-regulated drug study