KEYNOTE - D36: personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma
Georgina V Long, Pier Francesco Ferrucci, Adnan Khattak, Tarek M Meniawy, Patrick Alexander Ott, Michael Chisamore, Thomas Trolle, Agon Hyseni, Erik Heegaard, Georgina V Long, Pier Francesco Ferrucci, Adnan Khattak, Tarek M Meniawy, Patrick Alexander Ott, Michael Chisamore, Thomas Trolle, Agon Hyseni, Erik 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).
Keywords: AI-guided cancer vaccine design; EVX-01; PD-1; PD-L1; checkpoint inhibitor; immunotherapy; melanoma; neoantigen; pembrolizumab; personalized neoepitope vaccine.
Source: PubMed