A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510015-19-00

Enrollment

403

Registered

2024-02-26

Start date

2019-02-11

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder

Brief summary

pCR;EFS

Detailed description

EFS, pCR, EFS24 Proportion of patients who achieve

Interventions

DRUGGEMCITABINE

DRUGINFLIXIMAB

DRUGDURVALUMAB

DRUGMYCOPHENOLATE MOFETIL

DRUGCISPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
pCR;EFS	—

Secondary

Measure	Time frame
EFS, pCR, EFS24 Proportion of patients who achieve	—

Countries

Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026