Clinical trial · Interventional
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
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)
NCT05771480CI-TRIAL-00119801TOURMALINEactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Biological | Durvalumab | ALIAS |
| Gemcitabine + carboplatin | Drug | — | UNRESOLVED |
| Gemcitabine + cisplatin | Drug | — | UNRESOLVED |
| Gemcitabine + cisplatin + albumin-bound paclitaxel | Drug | — | UNRESOLVED |
| Gemcitabine + cisplatin + S-1 | Drug | — | UNRESOLVED |
| Gemcitabine monotherapy | Drug | — | UNRESOLVED |
| Gemcitabine + oxaliplatin | Drug | — | UNRESOLVED |
| Gemcitabine + S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab + Gemcitabine based chemotherapy
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Number of participants with Grade 3 or 4 possibly related adverse event (PRAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP
References
Publications (1)
- DERIVEDOh 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. PMID 42402265