Abstract:
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In oncology, vaccine-based immunotherapy often investigates regimens that demonstrate minimal toxicity overall and higher doses may not correlate with greater immune response. Rather than determining the maximum tolerated dose, the goal of the study becomes locating the optimal biological dose, which is defined as a safe dose demonstrating the greatest immunogenicity, based on some predefined measure of immune response. Incorporation of adjuvants, new or optimized peptide vaccines, and combining vaccines with immune modulators may enhance immune response, with the aim of improving clinical response. Innovative dose finding strategies are needed to establish the safety and immunogenicity of new immunologic combinations. This talk describes the implementation of an adaptive early-phase method for identifying the optimal regimen of a novel vaccination approach in an ongoing study. Operating characteristics of the design are demonstrated under various possible true scenarios via simulation studies. The results demonstrate the method's ability to effectively recommend optimal regimens in a high percentage of trials with manageable sample sizes.
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