Study identifier:D781PC00001
ClinicalTrials.gov identifier:NCT06467357
EudraCT identifier:N/A
CTIS identifier:N/A
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 Sept 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
No locations available
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 |