Design considerations for early-phase clinical trials of immune-oncology agents.

ABSTRACT:

Background

With numerous and fast approvals of different agents including immune checkpoint inhibitors, monoclonal antibodies, or chimeric antigen receptor (CAR) T-cell therapy, immunotherapy is now an established form of cancer treatment. These agents have demonstrated impressive clinical activity across many tumor types, but also revealed different toxicity profiles and mechanisms of action. The classic assumptions imposed by cytotoxic agents may no longer be applicable, requiring new strategies for dose selection and trial design.

Description

This main goal of this article is to summarize and highlight main challenges of early-phase study design of immunotherapies from a statistical perspective. We compared the underlying toxicity and efficacy assumptions of cytotoxic ver

SUBMITTER: Wages NA 

PROVIDER: S-EPMC6103998 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature