Durvalumab with Chemotherapy as First Line Treatment in Patients with Advanced Biliary Tract Cancers (aBTCs) - TOURMALINE

Study identifier:D4191C00140

ClinicalTrials.gov identifier:NCT05771480

EudraCT identifier:2022-002527-35

CTIS identifier:2022-502043-35

Recruiting

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)

Medical condition

biliary tract cancer

Phase

Phase 3

Healthy volunteers

Study drug

Gemcitabine monotherapy, Gemcitabine + cisplatin, Gemcitabine + oxaliplatin, Gemcitabine + carboplatin, Gemcitabine + cisplatin + S-1, Gemcitabine + S-1, Gemcitabine + cisplatin + albumin-bound paclitaxel

Sex

All

Estimated Enrollment

140

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Aug 2023

Estimated Primary Completion Date: 17 Sept 2025

Estimated Study Completion Date: 17 Mar 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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 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

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No locations available

Arms	Assigned Interventions
Experimental: Durvalumab + Gemcitabine based chemotherapy 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.	-

Arms

Assigned Interventions

Experimental: Durvalumab + Gemcitabine based chemotherapy
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.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]