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
AstraZeneca
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations. * Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease. * Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC. * Patients must provide an FFP…
Interventions
- DrugGemcitabine
Standard of care chemotherapy by intravenous infusion
- DrugCisplatin
Standard of care chemotherapy by intravenous infusion
- DrugDurvalumab
Standard of care immunotherapy by intravenous infusion
- DrugTrastuzumab deruxtecan
Experimental therapy by intravenous infusion
- DrugRilvegostomig
Experimental therapy by intravenous infusion
Locations (266)
- Research SiteScottsdale, Arizona
- Research SiteTucson, Arizona
- Research SiteTucson, Arizona
- Research SiteFullerton, California
- Research SiteLa Jolla, California
- Research SiteLos Alamitos, California