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TPS505 : A phase III, randomized, open-label, multicenter, global study of efficacy and safety of durvalumab in combination with gemcitabine plus cisplatin for neoadjuvant treatment followed by durvalumab alone for adjuvant treatment in muscle-invasive bladder cancer (NIAGARA).

Researchers

Presenter

  • Thomas Powles

Principal Investigators

  • Joshua J Meeks

  • Matt D. Galsky

  • Michiel Simon Van Der Heijden

  • Hiroyuki Nishiyama

  • Hikmat A Al-Ahmadie

  • Erik T. Goluboff

  • Stephan Hois

  • Sarah E. Donegan

  • Vanessa Williams

  • Feng Xiao

  • James WF Catto

Medical Centers

  • Barts Cancer Institute, Queen Mary University of London, London, United Kingdom

  • Northwestern University, Department of Urology, Feinberg School of Medicine, Chicago, IL

  • Mount Sinai Hospital, New York, NY

  • Netherlands Cancer Institute (NKI), Amsterdam, Netherlands

  • Department of Gastroenterology, University of Tsukuba, Tsukuba, Japan

  • Memorial Sloan Kettering Cancer Center, Port Washington, NY

  • AstraZeneca, Gaithersburg, MD

  • Department of Oncology & Metabolism, The Medical School, Sheffield, United Kingdom

Locations

  • United Kingdom

  • United States

  • Netherlands

  • Japan

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Bladder Cancer

  • Solid malignancies

Biomarkers

  • Programmed death-ligand 1

Drug/Treatment

  • Gemcitabine

  • Durvalumab

  • Cisplatin

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

  • Multinational

  • Multicenteric

Phase

  • III

Study Id's

  • NCT03732677

Sponsors

  • N/A

Result

  • N/A

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