Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies
09/2017
Journal Article
Authors:
Siu, L. L.;
Ivy, S. P.;
Dixon, E. L.;
Gravell, A. E.;
Reeves, S. A.;
Rosner, G. L.
Volume:
23
Pagination:
4950-4958
Issue:
17
Journal:
Clin Cancer Res
PMID:
28864723
URL:
https://www.ncbi.nlm.nih.gov/pubmed/28864723
DOI:
10.1158/1078-0432.CCR-16-3079
Keywords:
Clinical Trials as Topic Humans Immunotherapy/*trends Medical Oncology/trends Neoplasms/*drug therapy/*immunology
Abstract:
Immunotherapy adds an exciting new dimension to the treatment of cancer, joining other approaches as a key pillar in the oncotherapeutics armamentarium. Immuno-oncology agents harbor unique mechanisms of antitumor activity by leveraging the host immune system, which may result in response patterns, resistance kinetics, and toxicity profiles that differ from other systemic therapies. These features have led to many discussions on ways to optimally integrate immunotherapy into cancer clinical trials. This overview provides an introduction to the four CCR Focus articles that ensue, with special thoughts paid to clinical trial endpoints, biomarker development and validation, combination strategies, and limitations that arise with increasing use of these agents. In addition, this overview examines design concepts that may be applied to invigorate clinical trials and to maximize their impact in the immuno-oncology era.
