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NCT05309421 — Evaxion EVX-01 neoantigen vaccine trial

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

TrackingPhase 2Active Not RecruitingRegistry updated 22 Sept 2025
Phase 2phaseActive Not Recruitingregistry status17enrollment2025-09-30primary completion

EVX-01, Evaxion Biotech — with pembrolizumab in advanced melanoma, Phase 2

Registry IDNCT05309421
Lead sponsorEvaxion Biotech A/S
CollaboratorsMerck Sharp & Dohme LLC
PhasePhase 2
StatusActive Not Recruiting
IndicationMelanoma Stage IV, Unresectable Melanoma
Enrollment17 participants (target)
Start date2022-09-19
Primary completion2025-09-30 (est.)
Last registry update22 Sept 2025

Every field above is mirrored from the study record on ClinicalTrials.gov (NCT05309421), which the sponsor maintains and which carries the full protocol summary, eligibility criteria, sites and contacts. No neoantigen vaccine is approved anywhere yet — every program here is investigational, and inclusion is not an endorsement. See the methodology for how the tracker is built.

Daily coverage of the modality, tumor type and players this study touches:

What phase is NCT05309421?

NCT05309421 (A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma) is registered on ClinicalTrials.gov as Phase 2, sponsored by Evaxion Biotech A/S.

Is NCT05309421 recruiting?

As of the 2025-09-22 registry update, NCT05309421 is listed as "Active Not Recruiting". Eligibility criteria, study sites and contacts are maintained by the sponsor on the ClinicalTrials.gov record.

Who is running NCT05309421?

The lead sponsor is Evaxion Biotech A/S. Collaborators: Merck Sharp & Dohme LLC.

What condition does NCT05309421 study?

The registered conditions are Melanoma Stage IV, Unresectable Melanoma. Primary completion is listed as 2025-09-30 (estimated).

Are results available for NCT05309421?

neoag.ai mirrors the registry's factual fields — sponsor, phase, status and dates — and does not publish trial results. Any posted results, publications, or outcome measures appear on the ClinicalTrials.gov record for NCT05309421.

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