At a glance
ClinicalIndex Comparison Record- ✓At least 18 years of age
- ✓Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma
- ✓Prior adjuvant treatment allowed if >3 months elapsed before advanced/metastatic disease diagnosis
- ✓Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC
- ✕Prior HER2-targeting therapies, ADCs, checkpoint inhibitors, or therapeutic anticancer vaccines
- ✕Histologically confirmed ampullary carcinoma
- ✕Clinically significant cardiac or psychological conditions interfering with participation
- ✕Spinal cord compression or clinically active CNS metastases (untreated, symptomatic, requiring corticosteroids/anticonvulsants)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Gemcitabine, Cisplatin, and 3 other interventions for Biliary Tract Cancer. Currently recruiting, targeting 620 participants across 270 sites in 27 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm
Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
Gemcitabine and cisplatin in combination with durvalumab arm
Interventions
Standard of care chemotherapy by intravenous infusion
Standard of care chemotherapy by intravenous infusion
Standard of care immunotherapy by intravenous infusion
Experimental therapy by intravenous infusion
Experimental therapy by intravenous infusion