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

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Durvalumab; Gemcitabine; Oxaliplatin; Paclitaxel

Criteria

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 use an acceptable method of contraception 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 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 > 2) caused by previous anticancer therapy

• History of, or current, brain metastases or 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