Results of a randomized, double-blind phase II clinical trial of NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in participants with high-risk resected melanoma
Jonathan S Cebon, Martin Gore, John F Thompson, Ian D Davis, Grant A McArthur, Euan Walpole, Mark Smithers, Vincenzo Cerundolo, P Rod Dunbar, Duncan MacGregor, Cyril Fisher, Michael Millward, Paul Nathan, Michael PN Findlay, Peter Hersey, TR Jeffry Evans, Christian Hermann Ottensmeier, Jeremy Marsden, Angus G Dalgleish, Pippa G Corrie Show all
Journal for ImmunoTherapy of Cancer | BMJ PUBLISHING GROUP | Published : 2020
BACKGROUND: To compare the clinical efficacy of New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in a randomized, double-blind phase II study in participants with fully resected melanoma at high risk of recurrence. METHODS: Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1 were randomized to treatment with three doses of NY-ESO-1/ISCOMATRIX or ISCOMATRIX adjuvant administered intramuscularly at 4-week intervals, followed by a further dose at 6 months. Primary endpoint was the proportion free of relapse at 18 months in the intention-to-treat (ITT) population and two per-protocol populations. Se..View full abstract
Awarded by Ian Potter Foundation
Awarded by Cancer Research UK
This clinical study was sponsored and funded by the Ludwig Institute for Cancer Research. Certain proprietary rights to NY--ESO-1 have been licensed by the Ludwig Institute to CSL, which participated in the clinical study through the provision of clinical reagents and additional logistical support. JSC acknowledges support from the Cancer Research Institute, USA. AB acknowledges support from the Ian Potter Foundation, grant No. 20150678, and Operational Infrastructure Support Program Funding of the Victorian State Government. VC acknowledges support from the UK Medical Research Council and from Cancer Research UK (Programme grant #C399/A2291).