Design and conduct of early clinical studies of immunotherapy: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies 2019 (MDICT)

Martin Smoragiewicz, Alex A. Adjei, Emiliano Calvo, Josep Tabernero, Aurélien Marabelle, Christophe Massard, Jun Tang, Elisabeth G E de Vries, Jean-Yves Douillard, Lesley Seymour
2020 Clinical Cancer Research  
To review key aspects of the design and conduct of early clinical trials (ECT) of immunotherapy agents. The Methodology for the Development of Innovative Cancer Therapies (MDICT) Task Force 2019 included experts from academia, non-profit organisations, industry and regulatory agencies. The review focus was on methodology for ECTs testing immune-oncology therapies (IO) used in combination with other IO or chemotherapy. Although early successes have been seen, the landscape continues to be very
more » ... namic, and there are ongoing concerns regarding the capacity to test all new drugs and combinations in clinical trials. Optimisation of drug development methodology is required, taking in account early, late and lower grade intolerable toxicities, novel response patters, as well as pharmacodynamic data.
doi:10.1158/1078-0432.ccr-19-3136 pmid:32086344 fatcat:tll2z5npljbx7htvpdj2w5orym