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Biliary Tract CancerPhase 3TOURMALINENCT05771480

Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)

A Phase 3 study testing Durvalumab, Gemcitabine monotherapy and Gemcitabine + cisplatin in people with Biliary Tract Cancer, run by AstraZeneca at 34 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC. Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Durvalumab, Gemcitabine monotherapy and Gemcitabine + cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
34 sitesin 8 countries
Study dates
16 Aug 2023to 17 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP

Trial locations and contacts

34 sites in 8 countries.

34 sites in 8 countries

Japan9 sites

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Kanazawa, 920-8641

  • Research Site

    Kashiwa, 227-8577

  • Research Site

    Kyoto, 606-8507

  • Research Site

    Osaka, 541-8567

  • Research Site

    Sendai, 980-8574

  • Research Site

    Ube, 755-8505

  • Research Site

    Wakayama, 641-8509

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

Spain6 sites

  • Research Site

    Barcelona, 08035

  • Research Site

    Madrid, 28027

  • Research Site

    Madrid, 28040

  • Research Site

    Madrid, 28041

  • Research Site

    Pamplona, 31008

  • Research Site

    Seville, 41013

Other trials in Spain

Italy5 sites

  • Research Site

    Castelfranco Veneto, 31033

  • Research Site

    Foggia, 71122

  • Research Site

    Palermo, 90146

  • Research Site

    Pisa, 56126

  • Research Site

    Rozzano, 20089

Other trials in Italy

United States4 sites

  • Research Site

    Mobile, Alabama, 36607

  • Research Site

    Orange, California, 92868

  • Research Site

    Portland, Oregon, 97213

  • Research Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

France4 sites

  • Research Site

    Clichy, 92110

  • Research Site

    Dijon, 21079

  • Research Site

    Montpellier, 34090

  • Research Site

    Villejuif, 94800

Other trials in France

South Korea3 sites

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

Other trials in South Korea

Germany2 sites

  • Research Site

    Chemnitz, 09131

  • Research Site

    Hanover, 30625

Other trials in Germany

Singapore1 site

  • Research Site

    Singapore, 169610

Other trials in Singapore

About this study

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)

A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.

Read the 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.

Being tested
Durvalumab, Gemcitabine monotherapy, Gemcitabine + cisplatin, Gemcitabine + oxaliplatin, Gemcitabine + carboplatin
Keywords
monoclonal antibodies, PD-L1 antagonist, Durvalumab
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabBiological

    Also called Background Gemcitabine-based Chemotherapy Regimen

    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 monotherapyDrug

    Also called Background Gemcitabine-based Chemotherapy Regimen

    Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

  • Gemcitabine + cisplatinDrug

    Also called Background Gemcitabine-based Chemotherapy Regimen

    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 + oxaliplatinDrug

    Also called Background Gemcitabine-based Chemotherapy Regimen

    Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

  • Gemcitabine + carboplatinDrug

    Also called Background Gemcitabine-based Chemotherapy Regimen

    Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

  • Gemcitabine + cisplatin + S-1Drug

    Also called Background Gemcitabine-based Chemotherapy Regimen., This regimen is not allowed for countries in the European Union.

    Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks (i.e, 4 cycles of durvalumab)

  • Gemcitabine + S-1Drug

    Also called Background Gemcitabine-based Chemotherapy Regimen, This regimen is not allowed for countries in the European Union.

    Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

  • Gemcitabine + cisplatin + albumin-bound paclitaxelDrug

    Also called Background gemcitabine-based chemotherapy Regimen, This regimen is not allowed for countries in the European Union.

    Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)

Study groups in NCT05771480
Study groupRoleWhat they receive
Durvalumab + Gemcitabine based chemotherapyExperimentalParticipants 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.
Receives: Biological: Durvalumab; Drug: Gemcitabine monotherapy; Drug: Gemcitabine + cisplatin; Drug: Gemcitabine + oxaliplatin; Drug: Gemcitabine + carboplatin; Drug: Gemcitabine + cisplatin + S-1; Drug: Gemcitabine + S-1; Drug: Gemcitabine + cisplatin + albumin-bound paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 6 months after the initiation of Investigational Medicinal Product (IMP)

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS is defined as the time from the date of the first dose of IMP until death due to any cause.

    Measured: From the date of the first dose of IMP until death due to any cause [approx. upto 33 months]

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1.

    Measured: 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]

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose of IMP until the date of disease progression (PD) or death due to any cause.

    Measured: From the date of the first dose of IMP until until the date of objective PD or death [approx. up to 33 months]

  4. Disease Control Rate (DCR)

    DCR is defined as the % of participants who have a best objective response of complete response or partial response (by week 24 or 32), or who have stable disease for 24 or 32 weeks.

    Measured: Week 24 and Week 32

  5. Duration of Response (DOR)

    DOR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

    Measured: 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]

  6. Duration of Treatment (DOT)

    DOT is defined as time on study intervention.

    Measured: From date of start of IMP, until 27 days after last dose of IMP or date of death [approx. up to 33 months]

  7. Number of participants with AEs, including PRAEs, adverse events of special interest (AESIs), immune-mediated adverse events (imAEs) and serious adverse events (SAEs)

    To assess the safety and tolerability profile of durvalumab combined with background gemcitabine-based chemotherapy

    Measured: From the date of first dose of IMP until long-term follow-up i.e. until 90 days following discontinuation of the last dose of IMP [approx. up to 33 months]

  8. Number of participants with IRRs and hypersensitivity/anaphylactic reactions

    To assess the safety and tolerability profile of durvalumab combined with background gemcitabine-based chemotherapy

    Measured: From the date of first dose of IMP until 90 days following discontinuation of the last dose of IMP [approx. up to 33 months]

  9. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30)

    To assess disease and treatment related symptoms and HRQoL. EORTC QLQ-C30 consists of 30 items and measures symptoms, functioning, and global health status/QoL for all cancer types. Questions are grouped into 5 multi-item functional scales (physical, role, emotional, cognitive, and social), 3 multi-item symptom scales (fatigue, pain, and nausea/vomiting), a 2-item global QoL scale, 5 single items assessing additional symptoms commonly reported by cancer participants (dyspnoea, loss of appetite, insomnia, constipation, and diarrhoea), and one item on the financial impact of the disease. The EORTC QLQ-C30 is a valid and reliable PRO instrument in this participant population

    Measured: From date of first dose of IMP, until the date of the first clinically meaningful deterioration [approx. up to 33 months]

  10. EORTC QLQ-BIL21 Score

    To assess disease- and treatment related symptoms and HRQoL. The EORTC QLQ-BIL21 is a disease-specific (cholangiocarcinoma and cancer of the gallbladder) questionnaire. It consists of 21 items including one question each for side effects, equipment issues, and weight loss, as well as 5 scales (eating symptoms, jaundice symptoms, tiredness, pain, and anxiety). A higher score indicates greater difficulties. The EORTC QLQ-BIL21 is a valid and reliable PRO instrument in this participant population.

    Measured: From date of first dose of IMP, until the date of the first clinically meaningful deterioration [approx. up to 33 months]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start16 Aug 2023
  3. Primary completion2 Oct 2025
  4. Study completion17 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single arm study with durvalumab in combination with investigator's choice of 7 different background gemcitabine-based chemotherapy regimens in participants with aBTC.
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05771480
Sponsor's protocol ID
D4191C00140
Other IDs
2022-502043-35, 2022-002527-35
Acronym
TOURMALINE
Status last verified
Jul 2026
First submitted
6 Mar 2023
Last updated
29 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Oh DY, Ikeda M, Macarulla T, He AR, Park JO, Kitano M, Giordano G, Kim KP, Wirth T, Tai D, Bouattour M, Pressiani T, Dayyani F, Lamarca A, Emeribe U, Radke S, Sun P, Baur B, Vogel A. Durvalumab with gemcitabine-based chemotherapy regimens in advanced biliary tract cancer: primary results from the phase IIIb TOURMALINE study. J Hepatol. 2026 Jul 6:S0168-8278(26)02658-9. doi: 10.1016/j.jhep.2026.06.025. Online ahead of print.

    PubMed 42402265

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab, Gemcitabine monotherapy and Gemcitabine + cisplatin in people with Biliary Tract Cancer, run by AstraZeneca at 34 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Japan, Spain, Italy, United States, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Grade 3 or 4 possibly related adverse event (PRAE) (time frame: Within 6 months after the initiation of Investigational Medicinal Product (IMP)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05771480, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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