TU-04
Research type
Research Study
Full title
A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma (TROPION-Urothelial04)
IRAS ID
1012445
Contact name
Ghada Chaabani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2025-525030-57
Research summary
This study is for adults with muscle‑invasive urothelial cancer (MIUC) who have had surgery to remove all visible cancer but still have a higher chance of it returning. It is a Phase 3, randomized, open‑label study, meaning participants are randomly assigned to a treatment group, and both patients and doctors know which treatment is given. Most people receive treatment for up to one year.
The trial is testing how well datopotamab deruxtecan (Dato-DXd) alone or with rilvegostomig works, how safe they are, and how they act in the body compared to the standard of care (SoC). Standard of care in this study depends on what was given before surgery and may include nivolumab, durvalumab, or enfortumab vedotin with pembro.
Dato‑DXd is designed to attach to a protein called TROP2 on cancer cells and deliver chemotherapy directly to those cells. Rilvegostomig is an immunotherapy that helps the immune system find and attack cancer by blocking two signals on immune cells called PD‑1 and TIGIT.
This trial will include about 915 participants. To join this trial, participants must have had surgery less than 4 months ago intended to remove all detected cancer cells, but the doctors still consider that their cancer has a high risk of coming back. Participants are followed closely with regular checkups, blood and urine tests, scans (CT/MRI and bone scans), and heart and lung tests (including ECGs). During the treatment period, the visits frequency will be every 3 weeks in Arms 1 and 2 or every 2 to 4 weeks depending on SoC in Arm 3.
Researchers will monitor how long patients stay cancer‑free after surgery (disease‑free survival, DFS) and how long they live (overall survival, OS), with DFS also reviewed by an independent blinded committee. Blood tests will measure levels of Dato‑DXd and rilvegostomig and check for anti‑drug antibodies that might affect how the medicines work.
The study is sponsored by AstraZeneca and conducted across multiple countries.REC name
South Central - Oxford B Research Ethics Committee
REC reference
26/SC/0201
Date of REC Opinion
17 Jul 2026
REC opinion
Further Information Favourable Opinion