Study identifier:D781PC00001
ClinicalTrials.gov identifier:NCT06467357
EudraCT identifier:N/A
CTIS identifier:2023-508057-19-00
DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer
biliary tract cancer
Phase 3
No
Gemcitabine, Cisplatin, Durvalumab, Trastuzumab deruxtecan, Rilvegostomig
All
620
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
Location
Status
Location
Montreal, QC, Canada, H3A 1A1
Status
Recruiting
Location
Halifax, NS, Canada, B3H 1V7
Status
Recruiting
Location
Wien, Austria, 1090
Status
Not yet recruiting
Location
Linz, Austria, 4010
Status
Not yet recruiting
Location
Salzburg, Austria, 5020
Status
Not yet recruiting
Location
Porto Alegre, Brazil, 90035-000
Status
Recruiting
Location
Sao Paulo, Brazil, 01246-000
Status
Recruiting
Location
Toronto, ON, Canada, M5G 2M9
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Trastuzumab deruxtecan + rilvegostomig Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm | Drug: Trastuzumab deruxtecan Experimental therapy by intravenous infusion Other Name: DS-8201a; T-DXd Drug: Rilvegostomig Experimental therapy by intravenous infusion Diagnostic Test: Agilent HercepTest™ mAb pharmDx A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE breast cancer tissues routinely processed for histological evaluation. Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression utilising a fully automated IHC platform (Dako Omnis). Diagnostic Test: Ventana PD-L1 SP263 assay A qualitative immunohistochemical assay to determine the level of PD-L1 expression in FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1 protein using a VENTANA BenchMark ULTRA instrument |
Experimental: Trastuzumab deruxtecan Trastuzumab deruxtecan (T-DXd; DS-8201a) arm | Drug: Trastuzumab deruxtecan Experimental therapy by intravenous infusion Other Name: DS-8201a; T-DXd Diagnostic Test: Agilent HercepTest™ mAb pharmDx A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE breast cancer tissues routinely processed for histological evaluation. Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression utilising a fully automated IHC platform (Dako Omnis). Diagnostic Test: Ventana PD-L1 SP263 assay A qualitative immunohistochemical assay to determine the level of PD-L1 expression in FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1 protein using a VENTANA BenchMark ULTRA instrument |
Active Comparator: Standard of Care Gemcitabine and cisplatin in combination with durvalumab arm | Drug: Gemcitabine Standard of care chemotherapy by intravenous infusion Drug: Cisplatin Standard of care chemotherapy by intravenous infusion Drug: Durvalumab Standard of care immunotherapy by intravenous infusion Diagnostic Test: Agilent HercepTest™ mAb pharmDx A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE breast cancer tissues routinely processed for histological evaluation. Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression utilising a fully automated IHC platform (Dako Omnis). Diagnostic Test: Ventana PD-L1 SP263 assay A qualitative immunohistochemical assay to determine the level of PD-L1 expression in FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1 protein using a VENTANA BenchMark ULTRA instrument |
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