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

Publication ,  Journal Article
Isaacs, J; Tan, AC; Hanks, BA; Wang, X; Owzar, K; Herndon, JE; Antonia, SJ; Piantadosi, S; Khasraw, M
Published in: Clin Cancer Res
January 1, 2022

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.

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Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

January 1, 2022

Volume

28

Issue

1

Start / End Page

13 / 22

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • Neoplasms
  • Medical Oncology
  • Immunotherapy
  • Immunologic Factors
  • Humans
  • Clinical Trials as Topic
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
  • 1112 Oncology and Carcinogenesis
 

Citation

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Isaacs, J., Tan, A. C., Hanks, B. A., Wang, X., Owzar, K., Herndon, J. E., … Khasraw, M. (2022). Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res, 28(1), 13–22. https://doi.org/10.1158/1078-0432.CCR-21-1593
Isaacs, James, Aaron C. Tan, Brent A. Hanks, Xiaofei Wang, Kouros Owzar, James E. Herndon, Scott J. Antonia, Steven Piantadosi, and Mustafa Khasraw. “Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.Clin Cancer Res 28, no. 1 (January 1, 2022): 13–22. https://doi.org/10.1158/1078-0432.CCR-21-1593.
Isaacs J, Tan AC, Hanks BA, Wang X, Owzar K, Herndon JE, et al. Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res. 2022 Jan 1;28(1):13–22.
Isaacs, James, et al. “Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.Clin Cancer Res, vol. 28, no. 1, Jan. 2022, pp. 13–22. Pubmed, doi:10.1158/1078-0432.CCR-21-1593.
Isaacs J, Tan AC, Hanks BA, Wang X, Owzar K, Herndon JE, Antonia SJ, Piantadosi S, Khasraw M. Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res. 2022 Jan 1;28(1):13–22.

Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

January 1, 2022

Volume

28

Issue

1

Start / End Page

13 / 22

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • Neoplasms
  • Medical Oncology
  • Immunotherapy
  • Immunologic Factors
  • Humans
  • Clinical Trials as Topic
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
  • 1112 Oncology and Carcinogenesis