Bayesian sequential monitoring strategies for trials of digestive cancer therapeutics.

ABSTRACT:

Background

New therapeutics in oncology have presented challenges to existing paradigms and trial designs in all phases of drug development. As a motivating example, we considered an ongoing phase II trial planned to evaluate the combination of a MET inhibitor and an anti-PD-L1 immunotherapy to treat advanced oesogastric carcinoma. The objective of the paper was to exemplify the planning of an adaptive phase II trial with novel anti-cancer agents, including prolonged observation windows and joint sequential evaluation of efficacy and toxicity.

Methods

We considered various candidate designs and computed decision rules assuming correlations between efficacy and toxicity. Simulations were conducted to evaluate the operating characteristics of all designs.

Results

Design

SUBMITTER: Mulier G 

PROVIDER: S-EPMC11526600 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature