Document Type
Journal Article
Publication Title
Future oncology (London, England)
Volume
18
Issue
31
First Page
3473
Last Page
3480
PubMed ID
36047545
Publisher
Future Medicine Ltd
School
School of Medical and Health Sciences
RAS ID
54204
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).
DOI
10.2217/fon-2022-0694
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Comments
Long, G. V., Ferrucci, P. F., Khattak, A., Meniawy, T. M., Ott, P. A., Chisamore, M., ... & Heegaard, E. (2022). KEYNOTE–D36: Personalized immunotherapy with a neoepitope vaccine, EVX-01 and pembrolizumab in advanced melanoma. Future Oncology, 18(31), 3473-3480. https://doi.org/10.2217/fon-2022-0694