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Brief Title: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
Study ID: NCT03869190
Brief Summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA Department of Medicine, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
UCSF Comprehensive Cancer Ctr, San Francisco, California, United States
University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Memorial Sloan-Kettering Cancer Center, Commack, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Centre Francois Baclesse; Pharmacie, Caen, , France
Centre Leon Berard, Lyon, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Institut Claudius Regaud; Radiotherapie, Toulouse, , France
Gustave Roussy Cancer Campus, Villejuif, , France
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine, Athens, , Greece
Athens Medical Center; Dept. of Oncology, Athens, , Greece
University Hospital of Patras Medical Oncology, Patras, , Greece
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Severance Hospital; Yonsei Cancer Center; Yonsei University College of Medicine, Seoul, , Korea, Republic of
ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO, L?Hospitalet De Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas, Santiago de Compostela, LA Coruña, Spain
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Hospital del Mar, Barcelona, , Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Clinic i Provincial; Servicio de Neurologia, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital General Universitario Gregorio Mara, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz., Madrid, , Spain
Hospital Univ 12 de Octubre, Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
National Taiwan University Hospital, Yun-Lin Branch, Huwei Township, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Barts and The London, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Churchill Hospital; Pharmacy Clinical Trials Office, Pharmacy Department, Oxford, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom