drugset / Trial / NCT03435107

Durvalumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer

NCT03435107 ↗

Phase 2 Completed 33 enrolled Asan Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The POLE mutations represent high somatic mutation loads in patients with colorectal cancer, especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations might be susceptible to immune checkpoint blockade. Based on these reasons, the investigators planned a phase II study of durvalumab monotherapy in patients with previously treated, metastatic, MMR deficient (MSI-H) or POLE mutated colorectal cancer.

Timeline

Start
2018-04-12
Primary completion
2023-04-26
Completion
2023-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 20 mg/kg —
Subject Durvalumab Monoclonal antibody 1500 mg —

Indications