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ACTIVE NOT RECRUITING
NCT03046862
PHASE2

Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

\<Research Hypothesis\> The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered. The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer. \<Purpose of the study\> To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients.

Official title: Biomarker-oriented Study of Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2017-02-25

Completion Date

2024-12-31

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

Durvalumab 1.12 g iv on D1 every 3 weeks

DRUG

Tremelimumab

Tremelimumab 75mg iv on D1 every 3 weeks

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 iv on D1\& D8 every 3 weeks

DRUG

Cisplatin

Cisplatin 25 mg/m2 iv on D1\& D8 every 3 weeks

Locations (1)

Seoul National University Hospital

Seoul, South Korea