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Brief Title: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
Official Title: An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy
Study ID: NCT04586244
Brief Summary: This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.
Detailed Description: Participants will be stratified based on Programmed cell Death-Ligand 1 (PD-L1) Combined Positive Score ( CPS) \< 10 and PD-L1 CPS ≥ 10.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Iowa, Iowa City, Iowa, United States
University of Cincinnati, Cincinnati, Ohio, United States
Ohio State University Medical Center Division of H, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Hospital Saint Louis, Paris Cedex 10, , France
Hopital Europeen Georges Pompidou (Hegp), Paris Cedex 15, , France
Institut Gustave Roussy, Villejuif Cedex, , France
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari, , Italy
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milano, , Italy
Universita Campus Bio Medico Di Roma, Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma), Verona, , Italy
Name: Diane Hershock, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR