KEYNOTE – D36: Personalized Immunotherapy with a Neoepitope Vaccine, EVX-01 and Pembrolizumab in Advanced Melanoma
Georgina V. Long, Pier Francesco Ferrucci, Adnan Khattak, Tarek Meniawy, Patrick A. Ott, Michael Chisamore, Thomas Trolle, A. Hyseni, Erik D. Heegaard
Abstract
Despite improvements made with checkpoint inhibitor (CPI) therapy, a need for new approaches to improve outcomes for patients with unresectable or metastatic melanoma remains. EVX-01, a personalized neoepitope vaccine, combined with pembrolizumab treatment, holds the potential to fulfill this need. Here we present the rationale and novel design behind the KEYNOTE – D36 trial: an open label, single arm, phase II trial aiming to establish the clinical proof of concept and evaluate the safety of EVX-01 in combination with pembrolizumab in CPI naive patients with unresectable or metastatic melanoma. The primary objective is to evaluate if EVX-01 improves best overall response after initial stable disease or partial response to pembrolizumab treatment, in patients with advanced melanoma. The novel end points ensure a decisive readout which may prove helpful before making major investments in phase III trials with limited phase I data. Clinical Trial Registration: NCT05309421 (ClinicalTrials.gov)