Melanoma International Collaboration for Adaptive Trials (MICAT), a collaborative platform trial using adaptive trial design to test new agents and combinations in biomarker defined treatments for post-PD-1 treated metastatic melanoma, is transforming the development of melanoma therapies.
Building on Advances from I-SPY 2
I-SPY 2 is a Phase II screening trial that accelerates identification of active agents or combinations of drugs, and predictive biomarkers in the neo-adjuvant breast cancer treatment setting.
MICAT is a global academic-industry collaboration with advocacy and regulatory participation which will test multiple lines of therapy. MICAT will use adaptive statistical methods to enhance strategic decisions in Phase II and Phase III oncology trials. This patient-centric trial will bring effective therapies to the market sooner.
The MICAT Collaboration
PPD, AIM at Melanoma (AIM), International Melanoma Working Group (IMWG), Berry Consultants, and TechAtlas, a division of RA Capital Management are the key participants responsible for establishing MICAT.
The MICAT collaborative platform is designed to increase the speed of decision-making about:
- Specific drug or combination of compounds
- Relevant biomarkers
- Disease progression
- Optimal intervention strategies related to patient subpopulations
|MICAT Research Goals
- Concurrent evaluation of multiple candidate drugs
- Efficiency through use of single reference arms with multiple investigational arms
- Response adaptive allocation: assigns patients in each subpopulation to treatment based on Bayesian probability
- Tests treatment interaction with established and emerging biomarkers
- Drops or graduates candidate treatments based on posterior probabilities of success in Phase III
- Addresses key questions about the impact of the order in which treatments are given
- Identify therapies most likely to increase progression-free survival in advanced melanoma
- Test multiple regimens, including combinations
- Test sequencing of therapies
- Identify biomarker signatures to predict outcomes
- Accelerate key development decisions
Please contact PPD to learn more about this next-generation collaborative clinical trial platform. micat.SM@ppdi.com