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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)

Task Force Methodology Dev, 1-Jun-2020, In : Clinical Cancer Research. 26, 11, p. 2461-2465 5 p.

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  • Design and Conduct of Early Clinical Studies of Immunotherapy

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DOI

  • Task Force Methodology Dev

Purpose: To review key aspects of the design and conduct of early clinical trials (ECT) of immunotherapy agents.

Experimental Design: The Methodology for the Development of Innovative Cancer Therapies Task Force 2019 included experts from academia, nonprofit organizations, 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.

Results: Although early successes have been seen, the landscape continues to be very dynamic, and there are ongoing concerns regarding the capacity to test all new drugs and combinations in clinical trials.

Conclusions: Optimization of drug development methodology is required, taking into account early, late, and lower grade intolerable toxicities, novel response patterns, as well as pharmacodynamic data.

Original languageEnglish
Pages (from-to)2461-2465
Number of pages5
JournalClinical Cancer Research
Volume26
Issue number11
Publication statusPublished - 1-Jun-2020

    Keywords

  • TARGETED ANTICANCER THERAPY, PHASE-I, IMMUNE-RESPONSES, ANTIBODY, AGENTS, TUMOR, METAANALYSIS, OUTCOMES, TRIALS

ID: 135023090