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