Bladder Cancer Clinical Trial

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
Representative tumor specimens as specified by the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy greater than or equal to (>=) 12 weeks
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end organ function

Cohort 1-Specific Inclusion Criteria

No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma
Ineligible for cisplatin-based chemotherapy due to one of the following: Impaired renal function, a hearing loss of 25 decibels (dB) at two contiguous frequencies, Grade 2 or greater peripheral neuropathy, or ECOG performance score of 2

Exclusion Criteria:

Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
Leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled hypercalcemia (greater than [>] 1.5 millimoles per liter [mmol/L] ionized calcium or Ca > 12 milligrams per deciliter [mg/dL] or corrected serum calcium > upper limits of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
Malignancies other than urothelial bladder cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome or incidental prostate cancer
Pregnant and lactating women
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Serum albumin less than (<) 2.5 grams per deciliter (g/dL)
Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
Severe infections within 4 weeks prior to Cycle 1, Day 1
Significant cardiovascular disease
Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
Prior allogeneic stem cell or solid organ transplant
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

119

Study ID:

NCT02951767

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 77 Locations for this study

See Locations Near You

University of Alabama At Birmingham
Birmingham Alabama, 35294, United States
Pinnacle Oncology Hematology
Scottsdale Arizona, 85258, United States
Arizona Oncology - HOPE Wilmot
Tucson Arizona, 85710, United States
UCLA
Los Angeles California, 90024, United States
The Angeles Clinic and Research Institute - W LA Office
Los Angeles California, 90025, United States
USC Norris Cancer Center
Los Angeles California, 90033, United States
UCSF
San Francisco California, 94143, United States
Kaiser Permanente - San Marcos
San Marcos California, 92069, United States
Stanford Cancer Center
Stanford California, 94305, United States
Kaiser Permanente; Oncology Clinical Trials
Vallejo California, 94589, United States
Rocky Mountain Cancer Center - Aurora
Aurora Colorado, 80012, United States
University Of Colorado
Aurora Colorado, 80045, United States
University of Connecticut Health Center
Farmington Connecticut, 06030, United States
Yale Cancer Center ; Medical Oncology
New Haven Connecticut, 06520, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington District of Columbia, 20057, United States
Mayo Clinic Cancer Center
Jacksonville Florida, 32224, United States
Piedmont Cancer Institute, PC
Atlanta Georgia, 30318, United States
University of Chicago; Hematology/Oncology
Chicago Illinois, 60637, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Indiana University Health; Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
Norton Cancer Institute
Louisville Kentucky, 40402, United States
Massachusetts General Hospital;Oncology
Boston Massachusetts, 02114, United States
Dana Farber Cancer Inst. ; Dept. of Medical Oncology
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Minnesota Oncology Minneapolis
Minneapolis Minnesota, 55404, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Urology Cancer Center & GU Research Network
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
New York Oncology Hematology, P.C.
Albany New York, 12208, United States
NYU Langone Medical Center
New York New York, 10016, United States
Mount Sinai School of Medicine - Tisch Cancer Institute
New York New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
Case Western Reserve Univ; Hem/Onc
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene Oregon, 97401, United States
Kimmel Cancer Center Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville Tennessee, 37203, United States
Ctr for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Texas Oncology - Houston (Gessner)
Houston Texas, 77024, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates - Lake Wright Cancer Center
Norfolk Virginia, 23502, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Bcca - Cancer Center Southern Interior
Kelowna British Columbia, V1Y 5, Canada
BCCA-Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa Ontario, K1H 8, Canada
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto Ontario, M5G 2, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal Quebec, H3T 1, Canada
APHP - Hospital Saint Louis
Paris , 75475, France
Hopital Foch; Oncologie
Suresnes , 92151, France
Institut Gustave Roussy; Oncologie Medicale
Villejuif , 94800, France
Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
Berlin , 12200, Germany
Universitätsklinikum Düsseldorf; Urologische Klinik
Düsseldorf , 40225, Germany
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
Freiburg , 79106, Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg , 20246, Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München , 81675, Germany
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo Toscana, 52100, Italy
The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis
Amsterdam , 1066 , Netherlands
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
Barts and The London
London , EC1M , United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton , SM2 5, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral , L63 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

119

Study ID:

NCT02951767

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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