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BLADDER: Metasatatic: 1st Line: Immunotherapy: "D419BC00001"

A phase III, 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 bladder cancer

Title
AstraZeneca D419BC00001
Study Title
A phase III, 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 bladder cancer
Site Link
Malignancy
Bladder Cancer, First Line Bladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma of Bladder
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Durvalumab (MEDI4736) and Tremelimumab
Drug Class
Anti PD-L1 and Anti-CTLA-4
PI
Brad Somer, MD
Sponsor
AstraZeneca
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Unresectable Stage IV transitional cell carcinoma of the urothelium
  • No previous treatment in metastatic setting
  • PD-L1 status to be determined centrally prior to randomization
  • No prior anti-CTLA or anti PD-1 agents
  • No CNS involvement
  • No active or prior autoimmune disease
  • No HIV, HBV, HCV
Objective
Primary- PFS: Secondary- PFS for PD-L1neg pts: OS, ORR, QOL, PK
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Transitional Cell Carcinoma
Dosing Frequency
Control Agents
Cisplatin or Carboplatin and Gemcitabine
Study Protocol
Randomized
No
X