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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

Bladder Cancer

Interventions

Atezolizumab

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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