KEYNOTE – D36: personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma

Author:

Long Georgina V1ORCID,Ferrucci Pier Francesco2ORCID,Khattak Adnan3ORCID,Meniawy Tarek M4,Ott Patrick Alexander5,Chisamore Michael6,Trolle Thomas7ORCID,Hyseni Agon7,Heegaard Erik7

Affiliation:

1. Melanoma Institute Australia, The University of Sydney, & Royal North Shore & Mater Hospitals, Sydney, New South Wales, 2065, Australia

2. Cancer Biotherapy Unit, Department of Experimental Oncology, European Institute of Oncology IRCCS, Milan, 20139, Italy

3. Hollywood Private Hospital & Edith Cowan University, Perth, 6009, Australia

4. Linear Cancer Trials, Nedlands, 6009, Australia

5. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA

6. Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, NJ 07065, USA

7. Evaxion Biotech A/S, Dr. Neergaards Vej 5F, Hørsholm, 2970, Denmark

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 )

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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