Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
TOURMALINE
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)
3 other identifiers
interventional
142
8 countries
34
Brief Summary
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2023
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedStudy Start
First participant enrolled
August 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2026
ExpectedApril 21, 2026
April 1, 2026
2.1 years
March 6, 2023
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Grade 3 or 4 possibly related adverse event (PRAE)
PRAE is defined as an AE which has been assessed by the investigator to be possibly related to IMP.
Within 6 months after the initiation of Investigational Medicinal Product (IMP)
Secondary Outcomes (10)
Overall Survival (OS)
From the date of the first dose of IMP until death due to any cause [approx. upto 33 months]
Objective Response Rate (ORR)
From the date of first dose of IMP until progression, or the last evaluable assessment in the absence of progression [assessed up to 33 months]
Progression-Free Survival (PFS)
From the date of the first dose of IMP until until the date of objective PD or death [approx. up to 33 months]
Disease Control Rate (DCR)
Week 24 and Week 32
Duration of Response (DOR)
From the date of first documented response until the first date of documented progression or death in the absence of disease progression [approx. up to 33 months]
- +5 more secondary outcomes
Study Arms (1)
Durvalumab + Gemcitabine based chemotherapy
EXPERIMENTALParticipants 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.
Interventions
Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Participants will receive 1500 mg every 3 weeks, or every 4 weeks (in combination with chemotherapy every 3 weeks, or every 2 weeks, respectively) from cycle 1 to cycle 8 of chemotherapy. Upon completion, participants will receive 1500 mg every 4 weeks (as monotherapy)
Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine plus cisplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) for WHO/ECOG PS 2 participants only
Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks (i.e, 4 cycles of durvalumab)
Eligibility Criteria
You may qualify if:
- Histologically confirmed, unresectable advanced or metastatic biliary tract carcinoma (BTC) including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma
- Participants with unresectable or metastatic BTC
- A World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0 to 2
- At least one lesion that qualifies as a Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) target lesion at baseline
- Adequate organ and bone marrow function
- Body weight of \> 30 kg
- Negative pregnancy test (serum) for women of childbearing potential
- Female participants must be one year post-menopausal (amenorrhoeic for 12 months without an alternative medical cause)
- Male and female participants and their partners must be surgically sterile or on their chosen method of birth control as per the protocol.
You may not qualify if:
- Any evidence of diseases such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations, history of uncontrolled or symptomatic cardiac disease, and history of allogenic organ transplant
- Active or prior documented autoimmune or inflammatory disorders
- History of another primary malignancy, except for malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study intervention
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Known to have tested positive for human immunodeficiency virus \[HIV\] (positive HIV 1/2 antibodies) or active tuberculosis infection
- Participants co-infected with Hepatitis B virus (HBV) and Hepatitis C virus (HCV) or co-infected with HBV and Hepatitis D virus (HDV)
- Persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade \> 1) caused by previous anticancer therapy
- Central nervous system metastases requiring treatment or history of spinal cord compression
- Known allergy or hypersensitivity to any of the study intervention or any of the study intervention excipients.
- Any concurrent chemotherapy, other than the one allowed in the study, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment
- Palliative radiotherapy with a limited field of radiation within 2 weeks of the first dose of study intervention, or radiotherapy with a wide field of radiation or radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
- Major surgical procedure within 28 days prior to the first dose of IMP
- Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Mobile, Alabama, 36607, United States
Research Site
Orange, California, 92868, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
Clichy, 92110, France
Research Site
Dijon, 21079, France
Research Site
Montpellier, 34090, France
Research Site
Villejuif, 94800, France
Research Site
Chemnitz, 09131, Germany
Research Site
Hanover, 30625, Germany
Research Site
Castelfranco Veneto, 31033, Italy
Research Site
Foggia, 71122, Italy
Research Site
Palermo, 90146, Italy
Research Site
Pisa, 56126, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Chūōku, 104-0045, Japan
Research Site
Kanazawa, 920-8641, Japan
Research Site
Kashiwa, 227-8577, Japan
Research Site
Kyoto, 606-8507, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Ube, 755-8505, Japan
Research Site
Wakayama, 641-8509, Japan
Research Site
Yokohama, 241-8515, Japan
Research Site
Singapore, 169610, Singapore
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Barcelona, 08035, Spain
Research Site
Madrid, 28027, Spain
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28041, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Seville, 41013, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 16, 2023
Study Start
August 16, 2023
Primary Completion
October 2, 2025
Study Completion (Estimated)
September 17, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.