P43: Innovation in Collaborating and Funding an International Cancer Clinical Trial

International guidelines vary in recommendations for the width of excision for intermediate and thick primary cutaneous melanoma due to lack of high level evidence.  An international randomized trial, MelMart-II, is comparing 1 cm v 2 cm margins for patients with pT2b to pT4b melanoma. Results of the trial will have implications for patient morbidity, QOL, and cost of care. Sample size calculations indicate a total study size of 2998 patients necessitating an international multicenter approach.

The aim of this report is to describe the development and enablers of the international collaborative effort for this study.

Methods: MelMarT-II study is an international randomized study funded initially by the Australian Government National Health and Medical Research Council in 2018.

Results:

As of September 2023 1573 patients have been recruited from 142 sites in 12 countries including US (102 sites 543 patients), Canada (10, 166) UK (19, 347) and Australia (6, 205).

Factors contributing to the success of this study include

1 Recognition by melanoma surgeons internationally of this crucial issue requiring a randomized trial

2 Existing personal and collaborative relationships fostered by previous melanoma trials (eg MSLT-I, II), previous exchange of trainees and major melanoma meetings facilitated the planning and participation in this study

3 Initial pilot study of 400 patients from Australia, US, UK, Canada and Sweden permitted refinement of study eligibility criteria and processes and collection of health economic and QOL data, justifying funding

4 Australian Government regulations permitted funding for central trial activities including data management and randomization etc but prohibited off shore capitation payments. This required multiple international funding agreements in participating countries with either national grant bodies including US National Cancer Institute, Cancer Clinical Trials Canada, National Institute for Health Research UK and individual hospitals / institutions including Sweden, New Zealand, Netherlands, Slovenia

5 The COVID pandemic created barriers that delayed uptake of the trial and mandated extensive use of international teleconferencing and brought forward the use of telehealth and online collection of QOL and health economics data by participants.

Conclusions:

The Mel-Mart-II study is currently recruiting strongly with no significant issues. The size of this study necessitated a multinational, multicenter approach and a unique funding model with national grant bodies responsible for each individual nation’s trial activities.