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

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...

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Autores principales: Isaacs, James, Tan, Aaron C., Hanks, Brent A., Wang, Xiaofei, Owzar, Kouros, Herndon, James E., Antonia, Scott J., Piantadosi, Steven, Khasraw, Mustafa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Association for Cancer Research 2022
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8738124/
https://www.ncbi.nlm.nih.gov/pubmed/34312214
http://dx.doi.org/10.1158/1078-0432.CCR-21-1593
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author Isaacs, James
Tan, Aaron C.
Hanks, Brent A.
Wang, Xiaofei
Owzar, Kouros
Herndon, James E.
Antonia, Scott J.
Piantadosi, Steven
Khasraw, Mustafa
author_facet Isaacs, James
Tan, Aaron C.
Hanks, Brent A.
Wang, Xiaofei
Owzar, Kouros
Herndon, James E.
Antonia, Scott J.
Piantadosi, Steven
Khasraw, Mustafa
author_sort Isaacs, James
collection PubMed
description 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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spelling pubmed-87381242022-01-07 Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage Isaacs, James Tan, Aaron C. Hanks, Brent A. Wang, Xiaofei Owzar, Kouros Herndon, James E. Antonia, Scott J. Piantadosi, Steven Khasraw, Mustafa Clin Cancer Res Reviews 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. American Association for Cancer Research 2022-01-01 2022-01-05 /pmc/articles/PMC8738124/ /pubmed/34312214 http://dx.doi.org/10.1158/1078-0432.CCR-21-1593 Text en ©2021 The Authors; Published by the American Association for Cancer Research https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs International 4.0 License.
spellingShingle Reviews
Isaacs, James
Tan, Aaron C.
Hanks, Brent A.
Wang, Xiaofei
Owzar, Kouros
Herndon, James E.
Antonia, Scott J.
Piantadosi, Steven
Khasraw, Mustafa
Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage
title Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage
title_full Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage
title_fullStr Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage
title_full_unstemmed Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage
title_short Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage
title_sort clinical trials with biologic primary endpoints in immuno-oncology: concepts and usage
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8738124/
https://www.ncbi.nlm.nih.gov/pubmed/34312214
http://dx.doi.org/10.1158/1078-0432.CCR-21-1593
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