NCT04455503

Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1

A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Evaxion Biotech A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD, and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma who are at high risk of recurrence.

Detailed description

This study will be conducted in two parts: a safety, efficacy and PD response part using two different drug delivery methods and an expansion cohort. All patients will be administered with anti-PD-1 once every 4 weeks for up to 1 year commencing on Day 1 and with EVX-02 vaccine as soon as it is produced. Part 1 will consist of two cohorts: Cohort A: Will receive EVX- 02A delivered by delivery methodology 1. Cohort B: Will receive EVX- 02B delivered by delivery device 2. Part 2 (Cohort C) will be an expansion cohort. In this part, only one delivery methods, either EVX-02A or EVX-02B with will be used.

Conditions

• Melanoma Stage IV
• Melanoma Stage III

Interventions

Type	Name	Description
DRUG	EVX-02A	Up to 8 patients will receive EVX-02A administered IM.
DRUG	EVX-02B	Up to 8 patients will receive EVX-02B administered IM.
DRUG	EVX-02A OR EVX-02B	EVX-02A or EVX-02B will be used. Patients: 24 to 30

Timeline

• Start date: 2020-07-13
• Primary completion: 2023-02-28
• Completion: 2023-03-28
• First posted: 2020-07-02
• Last updated: 2024-02-21

Locations

6 sites across 1 country: Australia