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

Phase 2 Unknown 31 enrolled Seoul National University Hospital

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2017-02-25
Primary completion: 2020-05-30
Completion: 2024-12-31

Publications

Oh DY, Lee KH, Lee DW, Yoon J, Kim TY, Bang JH, Nam AR, Oh KS, Kim JM, Lee Y, Guthrie V, McCoon P, Li W, Wu S, Zhang Q, Rebelatto MC, Kim JW. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):522-532. doi: 10.1016/S2468-1253(22)00043-7. Epub 2022 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Subject	Durvalumab	Monoclonal antibody	1.12 g	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Tremelimumab	Monoclonal antibody	75 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications