Early 3+3 trial dose-escalation phase I clinical trial design and suitability for immune checkpoint inhibitors.

CONCLUSION: Our analysis shows a lack of consistent dose-toxicity or dose-response correlation with ICIs. Therefore, dose-escalation is not an appropriate design to conduct ICIs studies. Here we present an innovative trial design for immune modulating agents.
PMID: 33082209 [PubMed - as supplied by publisher]

Source: Clinical Cancer Research - October 20, 2020 Category: Cancer & Oncology Authors: Rahma OE, Reuss JE, Giobbie-Hurder A, Shoja E Razavi G, Abu-Shawer O, Mehra P, Gupta S, Simon R, Khleif SN Tags: Clin Cancer Res Source Type: research