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

Running, not enrolling · Phase 3

Conditions studied: Biliary Tract Cancer

In brief

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

Key facts

Study ID: NCT05771480
Run by: AstraZeneca
People needed: 142
Starts: 2023-08-16
Expected to finish: 2026-09-17
Last updated by the study team: 2026-07-29

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

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
Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP

Where it is running

Research Site — Mobile, Alabama, United States
Research Site — Orange, California, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Portland, Oregon, United States
Research Site — Clichy, France
Research Site — Dijon, France
Research Site — Montpellier, France
Research Site — Villejuif, France
Research Site — Chemnitz, Germany
Research Site — Hanover, Germany
Research Site — Castelfranco Veneto, Italy
Research Site — Foggia, Italy
Research Site — Palermo, Italy
Research Site — Pisa, Italy
Research Site — Rozzano, Italy
Research Site — Chūōku, Japan
Research Site — Kanazawa, 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 — Singapore, Singapore

Full record on ClinicalTrials.gov

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