An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
NCT07720284 · TU-04 Phase 3Recruiting
- Lead sponsor
- AstraZeneca (Industry)
- Enrollment
- 915 (estimated)
- Start date
- 16 Jul 2026
- Primary completion
- 11 Sep 2030 (estimated)
- Study completion
- 23 Nov 2032
- Last update posted
- 22 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Single
- Arms
- 3
Interventions
- Dato-DXd Drug
- Rilvegostomig Drug
- Durvalumab Drug
- Nivolumab Drug
- Pembrolizumab Drug
- Enfortumab vedotin Drug
Conditions and primary outcome
- High-risk Muscle Invasive Urothelial Carcinoma
Primary outcome
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of disease-free survival (DFS) (based on Investigator assessments). (From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07720284.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07720284 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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