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

NCT05309421 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: EVX-01-0012024-512393-10-00KEYNOTE-D36
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

Personalized immunotherapy; Personal cancer vaccine; cancer vaccine; EVX-01

Outcome Measures

Primary Outcomes (1)

• Change in the best overall response (BOR)

  Composite of a BOR of complete response (CR) or PR for patients with SD at the time of first EVX-01 administration and a BOR of CR for patients with PR at the time of first EVX-01 administration, within 2 years of treatment with pembrolizumab, as per RECIST 1.1 criteria

  Measurements at Baseline through study completion (up to 102 weeks)

Secondary Outcomes (6)

• Change in overall response rate

  Measurements at Baseline through study completion (up to 102 weeks)

• Change in progression free survival (PFS)

  Measurements at Baseline through study completion (up to 102 weeks)

• Change in overall survival (OS)

  Measurements at Baseline through study completion (up to 102 weeks)

• Number, type and severity of adverse events (AEs) and serious adverse events (SAEs)

  Measurements at Baseline through study completion (up to 102 weeks)

• Immunologic response induced by EVX-01

  Measurements at Baseline through study completion (up to 102 weeks)

Study Arms (1)

EVX-01 in combination with pembrolizumab

EXPERIMENTAL

EVX-01 is administered im. Pembrolizumab is administered according to label

Drug: EVX-01; Drug: Pembrolizumab 25 MG/ML

Interventions

EVX-01 DRUG

Investigational drug given in combination with standard of care

EVX-01 in combination with pembrolizumab

Pembrolizumab 25 MG/ML DRUG

Standard of care

Also known as: Keytruda

EVX-01 in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient may not have a diagnosis of uveal or ocular melanoma.
• Patients must be treatment naïve to checkpoint inhibitor (CPI) therapy
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evaxion Biotech A/S: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

Melanoma Institute Australia

Wollstonecraft, New South Wales, 2065, Australia

Location

One Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Divisione di Oncologia Medica del Melanoma

Milan, Italy

Location

Instituto Nazionale Tumori IRCCS Fondazione

Napoli, Italy

Location

Related Publications (1)

• Long GV, Ferrucci PF, Khattak A, Meniawy TM, Ott PA, Chisamore M, Trolle T, Hyseni A, Heegaard E. KEYNOTE - D36: personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma. Future Oncol. 2022 Oct;18(31):3473-3480. doi: 10.2217/fon-2022-0694. Epub 2022 Sep 1.

  PMID: 36047545 DERIVED

Related Links

• PR

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 4, 2022
• Study Start: September 19, 2022
• Primary Completion: September 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

IT (2); AU (2)