A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination with Standard of Care Chemotherapy and Durvalumab in Combination with Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510976-19-00

Acronym

D933SC00001

Enrollment

353

Registered

2024-06-28

Start date

2018-11-30

Completion date

Unknown

Last updated

2025-10-15

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

Conditions

Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer

Brief summary

Overall Survival (OS)

Detailed description

Progression Free Survival (PFS) - Overall Survival (OS) - Alive and Progression Free Patients at 12 Months (APF12) - Overall Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DoR) - Time from Randomization to Second Progression PFS (PFS2) - Safety - Disease related symptoms

Interventions

DRUGINFLIXIMAB

DRUGCISPLATIN

DRUGCARBOPLATIN

DRUGGEMCITABINE

DRUGMYCOPHENOLATE MOFETIL

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression Free Survival (PFS) - Overall Survival (OS) - Alive and Progression Free Patients at 12 Months (APF12) - Overall Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DoR) - Time from Randomization to Second Progression PFS (PFS2) - Safety - Disease related symptoms	—

Countries

Bulgaria, Czechia, Hungary, Italy, Poland, Spain

Outcome results

None listed

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