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.

Advanced HER2-expressing Biliary Tract Cancer

To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population

To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the FAS population (HER2 IHC 3+/2+)., To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations., To further evaluate efficacy of T‑DXd with rilvegostomig or in monotherapy vs SoC in terms of PFS in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations., To further evaluate the efficacy of T-DXd with rilvegostomig or in monotherapy vs SoC in terms of ORR in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations., To further evaluate efficacy of T‑DXd with rilvegostomig or in monotherapy vs SoC in terms of DoR in patients with HER2‑expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations., To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of OS, PFS, DoR and ORR in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations., To assess the safety and tolerability of T‑DXd with rilvegostomig or in monotherapy vs SoC., To assess the safety and tolerability of TDXd with rilvegostomig vs T-DXd monotherapy., To describe patient-reported tolerability of TDXd with rilvegostomig or in monotherapy in comparison to SoC based on a summary of symptomatic AEs and overall side-effect bother., To describe patient-reported tolerability of TDXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs and overall side-effect bother., To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig or in monotherapy vs SoC., To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy., To assess the PK of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in serum., To investigate the immunogenicity of T-DXd and of rilvegostomig.

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