Tailoring early-phase clinical trial design to address multiple research objectives.

ABSTRACT:

Introduction

In contemporary oncology drug development, implementation of novel early-phase designs with the ability to address multiple research objectives is needed to better refine regimens. This paper describes an adaptive design strategy for identifying a range of optimal regimens based on two endpoints within multiple cohorts. The proposed design was developed to address objectives in an early-phase trial of cancer vaccines in combination with agonistic antibodies to CD40 and CD27.

Materials and methods

We describe a model-based design strategy that was developed for a trial evaluating the safety and immunogenicity of vaccination with (1) peptides plus CD40 antibody and TLR3 ligand, (2) systemic administration of an agonistic CD27 antibody, and (3) to assess immune res

SUBMITTER: Wages NA 

PROVIDER: S-EPMC6952569 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature