Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.

Journal Article (Journal Article;Review)

Clinical trials that have a pharmacokinetic or a pharmacodynamic immunologic mechanism of action-based primary outcome could substantially improve the validity and efficiency of early development of immuno-oncology agents. Here, we outline different trial design options in this area, review examples from the literature and their unique immunologic aspects, and highlight how these trials have been underutilized. We illustrate how new technologies and translationally focused approaches can be successfully used to develop different classes of immunotherapeutic agents.

Full Text

Duke Authors

Cited Authors

  • Isaacs, J; Tan, AC; Hanks, BA; Wang, X; Owzar, K; Herndon, JE; Antonia, SJ; Piantadosi, S; Khasraw, M

Published Date

  • January 1, 2022

Published In

Volume / Issue

  • 28 / 1

Start / End Page

  • 13 - 22

PubMed ID

  • 34312214

Pubmed Central ID

  • PMC8738124

Electronic International Standard Serial Number (EISSN)

  • 1557-3265

Digital Object Identifier (DOI)

  • 10.1158/1078-0432.CCR-21-1593


  • eng

Conference Location

  • United States