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TPS504 : A phase III, randomized, open-label, multicenter, global study of first-line durvalumab plus standard of care (SoC) chemotherapy and durvalumab plus tremelimumab, and SoC chemotherapy versus SoC chemotherapy alone in unresectable locally advanced or metastatic urothelial cancer (NILE).

Researchers

Presenter

  • Matt D. Galsky

Principal Investigators

  • Andrea Necchi

  • Srikala S. Sridhar

  • Osamu Ogawa

  • Natasha Angra

  • Stephan Hois

  • Feng Xiao

  • Erik Goluboff

  • Joaquim Bellmunt

Medical Centers

  • Mount Sinai Hospital, New York, NY

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  • Princess Margaret Hospital, Toronto, ON, Canada

  • Kyoto University, Kyoto, Japan

  • AstraZeneca, Washington, DC

  • AstraZeneca, Gaithersburg, MD

  • Beth Israel Deaconess Medical Center, Boston, MA

Locations

  • United States

  • Italy

  • Canada

  • Japan

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Advanced Urothelial Carcinoma

  • Solid malignancies

Biomarkers

  • Programmed death-ligand 1

Drug/Treatment

  • Ticilimumab

  • Durvalumab

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

  • Multicenteric

Phase

  • III

Study Id's

  • NCT03682068

Sponsors

  • N/A

Result

  • N/A

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