PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer
Status:
Recruiting
Trial end date:
2021-08-31
Target enrollment:
Participant gender:
Summary
PD-1(programmed death protein 1)antibody has been to approved in patients with MSI-H/dMMR
advanced cancer and has achieved significant efficacy. It is reported that the objective
response rate of Pembrolizumab and Nivolumab are 40% and 31.1% in MSI-H/dMMR (microsatellite
instability-high/deficiency mismatch repair )colorectal cancer. What's more, most of the
patients who had response for PD-1 antibody achieved a long duration of disease control.
However, not all patients with MSI-H/dMMR was sensitive to PD-1 antibody despite it is a
biomarker for PD-1 antibody treatment. There were about 50-60% of patients with MSI-H/dMMR
were insensitive and we don't know why. What's more, it's reported that tumor mutation burden
(TMB) may be another biomarker of response to PD-1 therapy. COX (cyclooxygenase)inhibitor has
been proved to prevent adenomas in colorectal and it is safe for most of the patients.
Preclinical models also showed that COX inhibitor could act with PD-1 antibody in mice and
control disease progress. So, this study aims to evaluated efficacy and safety of combination
of PD-1 antibody and COX inhibitor in patients with MSI-H/dMMR or high tumor mutation burden
colorectal cancer.