TY - JOUR
T1 - Design and Conduct of Early Clinical Studies of Immunotherapy
T2 - Recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies 2019 (MDICT)
AU - the task force on Methodology for the Development of Innovative Cancer Therapies
AU - Smoragiewicz, Martin
AU - Adjei, Alex A.
AU - Calvo, Emiliano
AU - Tabernero, Josep
AU - Marabelle, Aurelien
AU - Massard, Christophe
AU - Tang, Jun
AU - de Vries, Elisabeth G.E.
AU - Douillard, Jean Yves
AU - Seymour, Lesley
N1 - Publisher Copyright:
© 2020 American Association for Cancer Research.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85085905220&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-19-3136
DO - 10.1158/1078-0432.CCR-19-3136
M3 - Review article
C2 - 32086344
AN - SCOPUS:85085905220
SN - 1078-0432
VL - 26
SP - 2461
EP - 2465
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 11
ER -