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

NCT04455503 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

  • Melanoma Stage IV
  • Melanoma Stage III

Interventions

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Evaxion Biotech A/S

    lead INDUSTRY

Principal Investigators

  • Dr Bavanthi Balakrishnar · Liverpool Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2023-02-28
Completion
2023-03-28

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455503 on ClinicalTrials.gov