Spots Global Cancer Trial Database for Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
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Trial Identification
Brief Title: Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
Official Title: A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination With Chemotherapy for the First Line Treatment for Patients With Advanced Biliary Tract Cancers (TOURMALINE)
Study ID: NCT05771480
Conditions
Study Description
Brief Summary: A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
Detailed Description: This study involves assessing the safety and efficacy of durvalumab in combination with different gemcitabine-based chemotherapy regimens as first line therapy for aBTC. The target population of interest in this study is participants with aBTC who are ≥ 18 years of age and above legal age per local regulations with WHO/ECOG PS of 0 to 2 at enrolment and who are not eligible for locoregional therapy. Participants with WHO/ECOG PS 2 will be capped at 20% of the overall treated participant population. The study consists of 4 periods: screening period (Day-28 to Day -1), treatment period up to 8 cycles of gemcitabine-based chemotherapy regimens with durvalumab, maintenance treatment with durvalumab alone or in combination with gemcitabine-based chemotherapy (with the exception of paclitaxel), and then safety and survival follow-up.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Mobile, Alabama, United States
Research Site, Orange, California, United States
Research Site, Washington, District of Columbia, United States
Research Site, Washington, District of Columbia, United States
Research Site, New York, New York, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Portland, Oregon, United States
Research Site, Clichy, , France
Research Site, Dijon, , France
Research Site, Lyon Cedex 03, , France
Research Site, Montpellier Cedex 5, , France
Research Site, Pessac, , France
Research Site, Rennes, , France
Research Site, Villejuif, , France
Research Site, Chemnitz, , Germany
Research Site, Freudenstadt, , Germany
Research Site, Hannover, , Germany
Research Site, Muenchen, , Germany
Research Site, Castelfranco Veneto, , Italy
Research Site, Foggia, , Italy
Research Site, Palermo, , Italy
Research Site, Pisa, , Italy
Research Site, Rozzano, , Italy
Research Site, Chuo-ku, , Japan
Research Site, Kanazawa-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kyoto, , Japan
Research Site, Osaka, , Japan
Research Site, Sendai, , Japan
Research Site, Ube, , Japan
Research Site, Wakayama, , Japan
Research Site, Yokohama, , Japan
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Pamplona, , Spain
Research Site, Sevilla, , Spain
Contact Details
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