Spots Global Cancer Trial Database for A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)
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Trial Identification
Brief Title: A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)
Official Title: A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Study ID: NCT02951767
Conditions
Interventions
Study Description
Brief Summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama At Birmingham, Birmingham, Alabama, United States
Pinnacle Oncology Hematology, Scottsdale, Arizona, United States
Arizona Oncology - HOPE Wilmot, Tucson, Arizona, United States
UCLA, Los Angeles, California, United States
The Angeles Clinic and Research Institute - W LA Office, Los Angeles, California, United States
USC Norris Cancer Center, Los Angeles, California, United States
UCSF, San Francisco, California, United States
Kaiser Permanente - San Marcos, San Marcos, California, United States
Stanford Cancer Center, Stanford, California, United States
Kaiser Permanente; Oncology Clinical Trials, Vallejo, California, United States
Rocky Mountain Cancer Center - Aurora, Aurora, Colorado, United States
University Of Colorado, Aurora, Colorado, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
Yale Cancer Center ; Medical Oncology, New Haven, Connecticut, United States
Georgetown University Medical Center Lombardi Cancer Center, Washington, District of Columbia, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
Piedmont Cancer Institute, PC, Atlanta, Georgia, United States
University of Chicago; Hematology/Oncology, Chicago, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Indiana University Health; Goshen Center for Cancer Care, Goshen, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Massachusetts General Hospital;Oncology, Boston, Massachusetts, United States
Dana Farber Cancer Inst. ; Dept. of Medical Oncology, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Minnesota Oncology Minneapolis, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Urology Cancer Center & GU Research Network, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
New York Oncology Hematology, P.C., Albany, New York, United States
NYU Langone Medical Center, New York, New York, United States
Mount Sinai School of Medicine - Tisch Cancer Institute, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Case Western Reserve Univ; Hem/Onc, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Willamette Valley Cancer Ctr - 520 Country Club, Eugene, Oregon, United States
Kimmel Cancer Center Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc, Nashville, Tennessee, United States
Ctr for Cancer and Blood Disorders, Fort Worth, Texas, United States
Texas Oncology - Houston (Gessner), Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Oncology Associates - Lake Wright Cancer Center, Norfolk, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Bcca - Cancer Center Southern Interior, Kelowna, British Columbia, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Lakeridge Health Oshawa; Oncology, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre; Oncology, Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
APHP - Hospital Saint Louis, Paris, , France
Hopital Foch; Oncologie, Suresnes, , France
Institut Gustave Roussy; Oncologie Medicale, Villejuif, , France
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie, Berlin, , Germany
Universitätsklinikum Düsseldorf; Urologische Klinik, Düsseldorf, , Germany
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie, Freiburg, , Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II, Hamburg, , Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik, München, , Germany
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia, Arezzo, Toscana, Italy
The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital, Birmingham, , United Kingdom
Barts and The London, London, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology, Sutton, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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