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

Phase 2 Active not recruiting 17 enrolled Evaxion Biotech A/S Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2022-09-19
Primary completion: 2025-09-30
Completion: 2026-03-30

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EVX-01	Vaccine	—	Intramuscular
Background	Pembrolizumab	Monoclonal antibody	25 mg/ml	—

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

Summary

Timeline

Publications

Drugs

Indications