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

Detailed criteria

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

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
Drug
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Drug
Rilvegostomig
Experimental therapy by intravenous infusion

Summary

Eligibility

Interventions

Locations (269)