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

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NCT07720284 · readout in 1,484 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Single · Treatment

Enrollment

915estimated

Sites

160

Countries

Australia, Brazil, Canada +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-07-16

actual

When the study began enrolling

Primary completion

2030-09-11

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2032-11-23

estimated

The whole study's end, after follow-up

First posted

2026-07-22

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

High-risk Muscle Invasive Urothelial Carcinoma

Interventions

Drug: Dato-DXd — also filed as Datopotamab deruxtecan, (Dato-DXd, DS-1062a)
Drug: Rilvegostomig — also filed as AZD2936
Drug: Durvalumab — also filed as Imfinzi, MEDI4736
Drug: Nivolumab — also filed as OPDIVO®, BMS-936558
Drug: Pembrolizumab — also filed as Keytruda, MK-3475
Drug: Enfortumab vedotin — also filed as Padcev®, ASG-22CE, AGS-22M6E

Primary outcome

what the primary-completion date above is the date OF

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).

measured 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).

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