Study identifier:D4191C00140
ClinicalTrials.gov identifier:NCT05771480
EudraCT identifier:2022-002527-35
CTIS identifier:2022-502043-35-01
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)
biliary tract cancer
Phase 3
No
Gemcitabine monotherapy, Gemcitabine + cisplatin, Gemcitabine + oxaliplatin, Gemcitabine + carboplatin, Gemcitabine + cisplatin + S-1, Gemcitabine + S-1, Gemcitabine + cisplatin + albumin-bound paclitaxel
All
142
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
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.
Location
Location
Washington, DC, United States, 20007
Location
Portland, OR, United States, 97213
Location
Seoul, Republic of Korea, 03080
Location
Barcelona, Spain, 08035
Location
Hannover, Germany, 30625
Location
Madrid, Spain, 28041
Location
Montpellier Cedex 5, France, 34090
Location
Villejuif, France, 94800
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab + Gemcitabine based chemotherapy Participants will receive durvalumab 1500mg every 3 or 4 weeks, in combination with continuation of all or some of the original background gemcitabine based chemotherapy every 3 or 2 weeks for up to a maximum of 8 cycles of chemotherapy. Durvalumab 1500mg is given as a 60-minute IV infusion in the first cycle (Day 1) and as a 30-minute IV infusion in following cycles. Upon completing 8 cycles of background gemcitabine-chemotherapy, or after discontinuing any of the combination chemotherapies due to toxicity before completing 8 cycles, participants are eligible to continue receiving durvalumab 1500 mg IV every 4 weeks either alone or in combination with gemcitabine-based chemotherapy (with the exception of paclitaxel), as per investigator’s discretion. | - |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.