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TPS4614 : A phase 3 study of the subcutaneous programmed cell death protein 1 inhibitor sasanlimab as single agent for patients with bacillus Calmette-Guérin, unresponsiv,e high-risk, non-muscle invasive bladder cancer CREST Study Cohort B.

Researchers

Presenter

  • Neal D. Shore

Principal Investigators

  • Thomas Powles

  • Jens Bedke

  • Matt D. Galsky

  • Evgeny Kopyltsov

  • Andrea Necchi

  • Joan Palou

  • Jennifer J. Vermette

  • Alison E. Randall

  • Kristen J. Pierce

  • Rossano Cesari

  • Gary D. Steinberg

Medical Centers

  • Carolina Urologic Research Center, Myrtle Beach, SC

  • Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust,, London, United Kingdom

  • Department of Dermatology Eberhard-Karls University of Tuebingen, Tuebingen, Germany

  • Tisch Cancer Institute at Mount Sinai, New York, NY

  • State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russian Federation

  • Vita-Salute San Raffaele University and Genitourinary Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy

  • Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain

  • Pfizer Oncology, Cambridge, MA

  • Pfizer Inc, New York, NY

  • Pfizer Oncology, Groton, CT

  • Pfizer Inc, Milan, Italy

  • Perlmutter Cancer Center NYU Langone, New York, NY

Locations

  • United States

  • United Kingdom

  • Germany

  • Russia

  • Italy

  • Spain

Companies

  • PharmAbcine Inc.

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Transitional cell carcinoma of the bladder

  • Bladder Cancer

  • Solid malignancies

Biomarkers

  • Programmed death-ligand 1

Drug/Treatment

  • stannous fluoride

Outcome

  • N/A


Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

  • Multinational

  • Multicenteric

  • Cohort

Phase

  • III

Study Id's

  • NCT04165317

Sponsors

  • N/A

Result

  • N/A