Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.
James IsaacsAaron C TanBrent A HanksXiaofei WangKouros OwzarJames E HerndonScott J AntoniaSteven PiantadosiMustafa KhasrawPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2021)
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.