BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations.

ABSTRACT:

Background

Personalized cancer treatment using combination therapies offers substantial therapeutic benefits over single-agent treatments in most cancers. However, unmet clinical needs and increasing market competition pressure drug developers to quickly optimize combination doses and clearly demonstrate the contribution of each component when developing and evaluating new combination treatments.

Methods

We propose a Bayesian optimal phase II drug-combination (BOP2-Comb) design that optimizes the combination dose and evaluates the proof-of-concept as well as the contribution of each component in two seamless stages. Our optimal calibration scheme minimizes the total trial sample size while controlling incorrect decision rates at nominal levels. This calibration procedure is

SUBMITTER: Chi X 

PROVIDER: S-EPMC12614245 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature