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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05309421
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Evaxion Biotech A/S
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma Stage III, Melanoma Stage IV

Additional Details

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.

Arms & Interventions

Arms

Experimental: EVX-01 in combination with pembrolizumab

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

Interventions

Drug: - EVX-01

Investigational drug given in combination with standard of care

Drug: - Pembrolizumab 25 MG/ML

Standard of care

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia

Status

Recruiting

Address

Melanoma Institute Australia

Wollstonecraft, New South Wales, 2065

Site Contact

Georgina Long

[email protected]

+61 (0) 2-9911-7200

Ballarat Central, Victoria, Australia

Status

Recruiting

Address

Ballarat Health Services (Grampians Health)

Ballarat Central, Victoria, 3350

Site Contact

Sharad Sharma, MD

[email protected]

+61 (0) 3-5320-8500

One Clinical Research, Nedlands, Western Australia, Australia

Status

Recruiting

Address

One Clinical Research

Nedlands, Western Australia, 6009

Site Contact

Adnan Khattak, Prof

[email protected]

+61 (08) 6279 9466

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Status

Recruiting

Address

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009

Site Contact

Tarek Meniawy

[email protected]

+61 (08) 6457 333

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