Phase 3 Study of T-DXd and Rilvegostomig versus SoC in Advanced HER2-expressing Biliary Tract Cancer - DESTINY-BTC01

Study identifier:D781PC00001

ClinicalTrials.gov identifier:NCT06467357

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

biliary tract cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Gemcitabine, Cisplatin, Durvalumab, Trastuzumab deruxtecan, Rilvegostomig

Sex

All

Estimated Enrollment

620

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 12 Aug 2024
Estimated Primary Completion Date: 12 Jun 2028
Estimated Study Completion Date: 16 May 2029

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Inclusion and exclusion criteria