Evaluating EVX-01 with Pembrolizumab for Advanced 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

This study is testing if a new treatment called EVX-01, when combined with pembrolizumab, can help adults with advanced melanoma feel better and improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Evaxion Biotech A/S (Industry-sponsored)
• Drugs / interventions: radiation, pembrolizumab
• Locations: 4 sites (Wollstonecraft, New South Wales and 3 other locations)
• Trial ID: NCT05309421 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of EVX-01 in combination with pembrolizumab in adults suffering from unresectable or metastatic melanoma. Participants will receive pembrolizumab from the start of the trial and will undergo immunization with EVX-01 starting at Week 12, with a total of 10 doses administered over the course of the study. The trial is designed as a single-arm study, comparing outcomes to historical data of patients treated with pembrolizumab alone. The treatment duration is expected to last up to 18 cycles, approximately two years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed, unresectable or metastatic melanoma Stage III or IV who are treatment naïve to checkpoint inhibitors.

Not a fit: Patients with uveal or ocular melanoma, or those who have previously received checkpoint inhibitor therapy, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel combination.

Eligibility criteria

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 ocular melanoma.
  2. Patients must be treatment naïve to checkpoint inhibitor (CPI) therapy
  3. Patients must have testing for a BRAF mutation prior to study entry.

Note: Patients with BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy as first-line systemic therapy and be eligible for this study as second line treatment. At the discretion of the investigator, patients with BRAF V600E mutant melanoma who have NOT received a BRAF inhibitor are also eligible for this study as first line treatment if they meet the following additional criteria:

i. LDH \< local ULN, ii. No clinically significant tumor related symptoms in the judgment of the investigator, and iii. Absence of rapidly progressing metastatic melanoma in the judgment of the investigator

* Have measurable disease per RECIST 1.1 as assessed by the local site investigator within 4 weeks prior to the first visit. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Patients must be willing and able to provide fresh or frozen tumor tissue from an unresectable or metastatic site of disease for neoepitope and biomarker analyses. If a sufficient amount of tumor tissue from an unresectable or metastatic site is not available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue. In addition, participants may provide additional biopsy at the time of discontinuation due to progression.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.

Where this trial is running

Wollstonecraft, New South Wales and 3 other locations

• Melanoma Institute Australia — Wollstonecraft, New South Wales, Australia (Recruiting)
• Ballarat Health Services (Grampians Health) — Ballarat Central, Victoria, Australia (Recruiting)
• One Clinical Research — Nedlands, Western Australia, Australia (Recruiting)
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Anders Jespersen, MD, PhD

Conditions Melanoma Stage III; Melanoma Stage IV