An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection. Study details: Duration: \~78 months (6.5 years) from FSI to last subject visit Treatment length: up to \~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

NCT Number	NCT07720284
Lead Sponsor	AstraZeneca Collaborators: Daiichi Sankyo
Conditions	High-risk Muscle Invasive Urothelial Carcinoma
Enrollment	915 participants
Start Date	2026-07-16
Primary Completion	2030-09-11 (estimated)
Study Completion	2032-11-23 (estimated)
Updated on ClinicalTrials.gov	2026-07-22