Durvalumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

April 12, 2018

Primary Completion Date

April 26, 2023

Study Completion Date

April 26, 2023

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Durvalumab

"Study treatment consists of durvalumab 1500 mg Q4W for patients \> 30 kg, and will be repeated every 4 weeks. For patients ≤ 30 kg, weight based dosing of 20 mg/kg durvalumab Q4W will be used.~Response evaluation will be performed every 8 weeks (± 1-week window period). Treatment will be continued until disease progression, unacceptable adverse events or the patient's refusal.~Treatment through progression is at the investigator's discretion, and the investigator should ensure that patients do not have any significant, unacceptable, or irreversible toxicity that indicate that continuing treatment will not further benefit the patient. The Investigator should ensure that patients still meet all of the inclusion criteria and none of the exclusion criteria for this study."

Trial Locations (1)

05505

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER