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A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma
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.
Study 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-08-30
Primary completion: 2025-06-28
Study completion finish: 2025-07-25
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05309421
Intervention or treatment
DRUG: EVX-01
DRUG: Pembrolizumab 25 MG/ML
Conditions
- • Melanoma Stage III
- • Melanoma Stage IV
Find a site
Closest Location:
Melanoma Institute Australia
Research sites nearby
Select from list below to view details:
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Ballarat Health Services (Grampians Health)
Ballarat Central, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: EVX-01 in combination with pembrolizumab
| DRUG: EVX-01
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in overall response rate | Overall response rate, defined as the proportion of the patients who have best response as CR or PR assessed 2 years after initiation of treatment with pembrolizumab, as per RECIST 1.1 criteria | Measurements at Baseline through study completion (up to 102 weeks) |
Change in progression free survival (PFS) | PFS in patients with an assessment of SD, PR, or CR at the time of first EVX-01 administration, assessed 2 years after initiation of treatment with pembrolizumab and defined as the time from the first EVX-01 administration to the first documented disease progression per RECIST 1.1. criteria or death due to any causes, whichever occurs first | Measurements at Baseline through study completion (up to 102 weeks) |
Change in overall survival (OS) | OS assessed 2 years after initiation of treatment with pembrolizumab and defined as the time from initiation of treatment of pembrolizumab to death due to any cause | Measurements at Baseline through study completion (up to 102 weeks) |
Number, type and severity of adverse events (AEs) and serious adverse events (SAEs) | Number, type and severity of adverse events (AEs) and serious adverse events (SAEs) to evaluate the safety of EVX-01 in patients with metastatic or unresectable melanoma on pembrolizumab treatment | Measurements at Baseline through study completion (up to 102 weeks) |
Immunologic response induced by EVX-01 | Activation and level of neoepitope specific CD4+ and CD8+ T-cells before, during and after EVX-01 immunization | Measurements at Baseline through study completion (up to 102 weeks) |
Percentage of patients in which EVX-01 is generated, produced, and administered | Percentage of patients in which EVX-01 is generated, produced, and administered to evaluate the manufacturing feasibility of EVX-01 | From tumor biopsy sampling to first dose of EVX-01 (up to 16 weeks) |
Frequently Asked Questions
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