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.
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
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There are 77 Locations for this study
Birmingham Alabama, 35294, United States
Scottsdale Arizona, 85258, United States
Tucson Arizona, 85710, United States
Los Angeles California, 90024, United States
Los Angeles California, 90025, United States
Los Angeles California, 90033, United States
San Francisco California, 94143, United States
San Marcos California, 92069, United States
Stanford California, 94305, United States
Vallejo California, 94589, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
Farmington Connecticut, 06030, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20057, United States
Jacksonville Florida, 32224, United States
Atlanta Georgia, 30318, United States
Chicago Illinois, 60637, United States
Harvey Illinois, 60426, United States
Goshen Indiana, 46526, United States
Louisville Kentucky, 40402, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55404, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89128, United States
Albany New York, 12208, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10065, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Eugene Oregon, 97401, United States
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Seattle Washington, 98109, United States
Kelowna British Columbia, V1Y 5, Canada
Vancouver British Columbia, V5Z 4, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Paris , 75475, France
Suresnes , 92151, France
Villejuif , 94800, France
Berlin , 12200, Germany
Düsseldorf , 40225, Germany
Freiburg , 79106, Germany
Hamburg , 20246, Germany
München , 81675, Germany
Milano Lombardia, 20133, Italy
Arezzo Toscana, 52100, Italy
Amsterdam , 1066 , Netherlands
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Birmingham , B15 2, United Kingdom
London , EC1M , United Kingdom
London , W1G 6, United Kingdom
Sutton , SM2 5, United Kingdom
Wirral , L63 4, United Kingdom
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