Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EVX-01 · 1 trial · 2 indications
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
| Arm | Type | Description |
|---|---|---|
| EVX-01 in combination with pembrolizumab | EXPERIMENTAL | EVX-01 is administered im. Pembrolizumab is administered according to label |
| Name | Type | Description |
|---|---|---|
| EVX-01 | DRUG | Investigational drug given in combination with standard of care |
| Pembrolizumab 25 MG/ML | DRUG | Standard of care |
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 ocul...
EVX-01 is an investigational vaccine being studied for unresectable or metastatic melanoma, including Melanoma Stage IV. It is being evaluated in combination with pembrolizumab in adults 18 years and older. EVX-01 is a personalized cancer vaccine approach in oncology and remains in clinical development.
EVX-01 is being developed by Evaxion A/S, a biotech company whose ticker is EVAX. Evaxion is the sponsor behind the clinical program evaluating EVX-01 in melanoma. The asset is a vaccine modality within the oncology therapeutic area.
EVX-01 is in Phase 2 clinical development. It has not been established as an approved therapy; it is an investigational vaccine still being studied in clinical trials. The Phase 2 program has focused on patients with unresectable or metastatic melanoma treated in combination with pembrolizumab.
EVX-01 has been studied in NCT05309421, a single-arm Phase 2 trial evaluating its efficacy and safety in combination with pembrolizumab in adults with unresectable or metastatic melanoma. The trial enrolled 17 patients across Australia and Italy and is listed as completed. It was uncontrolled, non-randomized, and open-label.
Yes, the EVX-01 Phase 2 trial NCT05309421 was biomarker selected, meaning enrollment was tied to a defined biomarker profile. The study was a single-arm, uncontrolled design with 17 participants, all adults aged 18 years and older, and it enrolled no healthy volunteers. It took place in Australia and Italy.