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Activity Number: 148 - Statistical Methods, Challenges and Impacts on Early Phase Trials
Type: Invited
Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
Sponsor: ENAR
Abstract #300427
Title: Model-Based Phase I Designs for Immuno-Oncology
Author(s): Jun Yin* and Yu Du and Sumithra Mandrekar
Companies: Mayo Clinic and Eli Lilly and Company and Mayo Clinic

In the era of cancer immunotherapies, several aspects of phase I designs need to evolve in order to adapt to the changing nature of cancer therapies. We have developed novel phase I designs to incorporate toxicity scores from multiple treatment cycles, as well as evaluation of early efficacy, for identification of tolerable and efficacious doses. The designs are calibrated with respect to specific operating characteristics. We conducted extensive simulations to assess the performance of our proposed designs with comparison to previous published work.

Authors who are presenting talks have a * after their name.

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