The first adaptive platform trial in melanoma—and one of the only adaptive platform trials that will be in existence for any cancer—is managed and funded by AIM at Melanoma.
What’s an adaptive platform trial?
In traditional clinical trials, new therapies are tested one or two at a time against the standard of care, a methodical but slow approach to finding new treatments. Patients are randomized to the standard therapy or the new therapy, and regardless of how they are faring, continue with their therapy until the end of the study or, sadly, their death. Unfortunately, the majority of clinical trials end with the finding that the new treatment is no better than the standard approach.
Adaptive platform trials are different. First, they have multiple arms, allowing several new treatments to be simultaneously compared to a standard arm. Second, unlike traditional clinical trials, the adaptive trial protocol allows researchers to review results as the study progresses and reassign patients to treatment arms that are performing better. Finally, adaptive trials are biomarker-driven, allowing researchers to collect and use data that will yield personalized treatments. In short, adaptive trials lead to personalized therapies and faster answers on a drug’s efficacy—and, thus, save lives in the process.
Adaptive platform trials can run for years. Unsuccessful drugs are dropped, and new arms can be added as soon as they’re ready to be tested. Adaptive platform trials are the most efficient way to find successful treatments.
Melanoma needs an adaptive platform trial. AIM will give us MICAT.
In 2018 AIM moved ever closer to the opening of the trial. The board of directors was formed; the key researchers were signed on; the sites for patient accrual were selected; and preliminary discussions were begun with the FDA.
AIM is now seeking philanthropic support for the start-up costs of the study, which total $5.5M. The goal for 2019 is to get that seed funding and open the trial.
It’s worth noting that the initial funding for MICAT might come from an entity without a specific interest in melanoma. Why? Because melanoma has the most mutations of any solid cancer, which makes it a solid testing ground for new immunotherapies and targeted therapies for all cancers: Treatments that have been viable for melanoma have also proved to be viable in other cancers.
MICAT will be a transformational project for melanoma, but we must get it funded. 2019, here we come!