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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 verydoi:10.1158/1078-0432.ccr-19-3136 pmid:32086344 fatcat:tll2z5npljbx7htvpdj2w5orym