A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513399-17-00

Acronym

DANUBE/D419BC00001

Enrollment

Registered

2024-10-08

Start date

2015-12-11

Completion date

2025-04-15

Last updated

2025-06-20

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

Conditions

Adult patients (age ≥18 years) with histologically or cytologically documented transitional cell carcinoma (transitional cell and mixed transitional/non transitional cell histologies) of the urothelium (including renal pelvis, and urethra), and who are chemotherapy-naïve., unresectable Stage IV, ureters, urinary bladder

Brief summary

overall survival (OS)

Detailed description

"1. Progression-free survival (PFS); 2. OS24; 3. Proportion of patients alive and progression-free at 12 months; 4. Objective response rate; 5. Duration of response; 6. Disease control rate; 7. Best objective response; 8. Time from randomization to second progression"

Interventions

DRUGMYCOPHENOLATE MOFETIL

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

DRUGINFLIXIMAB

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
"1. Progression-free survival (PFS); 2. OS24; 3. Proportion of patients alive and progression-free at 12 months; 4. Objective response rate; 5. Duration of response; 6. Disease control rate; 7. Best objective response; 8. Time from randomization to second progression"	—

Countries

Greece, Spain

Outcome results

None listed

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