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Activity Number: 140 - Design and Analysis of Cancer Immunotherapy Trials
Type: Invited
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #326596 Presentation
Title: A Bayesian Phase I/II Trial Design for Immunotherapy
Author(s): Suyu Liu* and Beibei Guo and Ying Yuan
Companies: MD Anderson Cancer Center and Louisiana State University and University of Texas M.D. Anderson Cancer Center
Keywords: Immunotherapy; phase I/II trial; dose finding; risk-benefit tradeoff

Immunotherapy is an innovative treatment approach that stimulates a patient's immune system to fight cancer. It demonstrates characteristics distinct from conventional chemotherapy and stands to revolutionize cancer treatment. We propose a Bayesian phase I/II dose-finding design that incorporates the unique features of immunotherapy by simultaneously considering three outcomes: immune response, toxicity and efficacy. The objective is to identify the biologically optimal dose, defined as the dose with the highest desirability in the risk-benefit tradeoff. An Emax model is utilized to describe the marginal distribution of the immune response. Conditional on the immune response, we jointly model toxicity and efficacy using a latent variable approach. Using the accumulating data, we adaptively randomize patients to experimental doses based on the continuously updated model estimates. A simulation study shows that our proposed design has good operating characteristics in terms of selecting the target dose and allocating patients to the target dose.

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

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