Comparing Trastuzumab Deruxtecan with Rilvegostomig to Standard Chemotherapy and Durvalumab for Advanced HER2-Positive Biliary Tract Cancer

What this Trial Is About

This research is investigating the safety and effectiveness of combining Trastuzumab deruxtecan T-DXd with rilvegostomig, compared to T-DXd alone or the standard chemotherapy regimen of gemcitabine plus cisplatin with durvalumab in patients who have advanced HER2-expressing biliary tract cancer and have not received prior treatment. The study focuses on patients with unresectable, locally advanced, or metastatic biliary tract adenocarcinoma that expresses HER2 protein. Participants are randomly assigned to one of three groups one receiving T-DXd combined with rilvegostomig, another receiving T-DXd alone, and a third group receiving standard chemotherapy with gemcitabine and cisplatin plus durvalumab. All therapies are given by intravenous infusion. The study includes an initial safety run-in phase where participants complete at least one 21-day treatment cycle, followed by a randomized portion that will assess overall survival and other efficacy measures over an estimated period of up to 50 months. During the study, participants will undergo assessments including tumor tissue testing to confirm HER2 expression, evaluations of tumor lesions using RECIST criteria, and monitoring of physical function and adverse effects. Blood samples will be collected to analyze drug levels and immune responses. Researchers will track overall survival, progression-free survival, response rates, and patient-reported tolerability throughout the treatment and up to the studys end. The study duration extends until the final data collection, which may be up to several years after enrollment.

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer