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Spots Global Cancer Trial Database for An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Diane Hershock, MD

Affiliation: Incyte Corporation

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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