NCT04298008

AZD6738 Plus Durvalumab in Biliary Tract Cancer

Combination of AZD6738 Plus Durvalumab in Refractory Biliary Tract Cancer in Patients Who Have Failed Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This trial will enroll advanced biliary tract cancer patients who have been previously treated with immunotherapy in either the 2nd or 3rd line. Patients will be treated with AZD6738 and Durvalumab combination.

Detailed description

This is a single arm, phase II study. Advanced BTC patients who have been previously treated with immunotherapy in either the 2nd or 3rd line will be enrolled. Patients will be treated with AZD6738 and Durvalumab combination. One cycle consists of 4weeks. Response evaluation will be done every 8 weeks (every 2 cycles) of treatment 1. Tumor biopsy is mandatory: screening, after 8weeks (1st-response evaluation), at disease progression (PD) 2. blood sampling for biomarker study is mandatory: every cycles 3. To evaluate the metabolic changes by AZD6738 and Durvalumab combination : 18 F-FDG PET is mandatory : screening, after 8 weeks (1st-response evaluation)

Conditions

• Bile Duct Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	AZD6738	AZD6738 (240 ) mg bid on D15-D28 Every 4 weeks
DRUG	Durvalumab	Durvalumab 1500 mg iv on D1 Every 4 weeks

Timeline

• Start date: 2020-06-25
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2020-03-06
• Last updated: 2024-04-19

Locations

1 site across 1 country: South Korea