Study identifier:D419BC00001
ClinicalTrials.gov identifier:NCT02516241
EudraCT identifier:2015-001633-24
CTIS identifier:N/A
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Cancer
Urothelial Cancer
Phase 3
No
MEDI4736 (Durvalumab), Tremelimumab, Cisplatin, Carboplatin, Gemcitabine
All
1126
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Combination Therapy MEDI4736 (Durvalumab) + Tremelimumab | Drug: MEDI4736 (Durvalumab) IV infusion Drug: Tremelimumab IV infusion |
Experimental: Monotherapy MEDI4736 (Durvalumab) | Drug: MEDI4736 (Durvalumab) IV infusion |
Active Comparator: Standard of Care Standard of Care Chemotherapy Treatment | Drug: Cisplatin IV infusion Drug: Carboplatin IV infusion Drug: Gemcitabine IV infusion |