Health Condition 1: null- Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract. Health Condition 2: C67- Malignant neoplasm of bladder
Conditions
Interventions
Intervention1: Study drug - Atezolizumab: The dose of atezolizumab in this study will be 1200 mg administered by intravenous infusion every 3 weeks (21 [± 3] days).
Control Intervention1: Not applicab
Sponsors
F HoffmanLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Signed informed consent form Age more than 18 years Histologically documented locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract Patients with measurable and non-measurable disease according to RECIST v1.1 are allowed Must have received one prior combination chemotherapy regimen for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract Eastern Cooperative Oncology Group Performance Status 0, 1 or 2 Representative formalin-fixed paraffin-embedded tumor specimen block available for submission Life expectancy more than 12 weeks Adequate hematologic and end-organ function Patients with treated, asymptomatic central nervous system metastases are eligible For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than 1 percent per year during the treatment period and for at least 5 months after the last dose of atezolizumab
Exclusion criteria
Exclusion criteria: Treatment with more than one prior line of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract and any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation Treatment with chemotherapy within 2 weeks prior to study treatment initiation Treatment with radiotherapy ongoing at the time of study entry (for CNS-directed radiotherapy, please refer to Inclusion Criterion 10) Pregnant or lactating, or intending to become pregnant during the study Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1 Significant cardiovascular disease, such as New York Heart Association cardiac disease more than Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina, renal disorder Signs or symptoms of severe infection within 2 weeks prior to initiation of study treatment Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, history of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks. History of idiopathic pulmonary fibrosis evidence of active pneumonitis on screening chest (CT) scan Known hypersensitivity or allergy to biopharmaceuticals or any component of the atezolizumab formulation, Prior allogeneic stem cell or solid organ transplantation Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C Active tuberculosis Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation. Prior treatment with CD137 agonists or immune checkpoint blockade therapies Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment Specifically for patients without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to study treatment initiation or anticipated requirement for systemic immunosuppressive medications during the study treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the safety of atezolizumab based on the following endpoints: 1) Nature, severity, duration, frequency and timing of adverse events (AEs) 2) Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab administrationTimepoint: The primary objective of this study is to evaluate the safety of atezolizumab based on the following endpoints: 1) Nature, severity, duration, frequency and timing of adverse events (AEs) 2) Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The secondary objectives of the study include evaluation of the efficacy of atezolizumab based on OS, ORR, PFS, DCR and DoR 2) Evaluation of efficacy of atezolizumab according to the following patient-reported outcomes (PROs; Appendix 4): · Change from baseline in health-related quality of life (HRQoL), as assessed using the EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30) · EuroQol EQ-5D-5L-assessed utility Timepoint: The primary objective of this study is to evaluate the safety of atezolizumab based on the following endpoints: 1) Nature, severity, duration, frequency and timing of adverse events (AEs) 2) Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab administration | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, India, Ireland, Italy, Lebanon, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, United Kingdom
Contacts
Public ContactManjula Ujagiri
Roche Products (India) Pvt. Ltd.
Outcome results
None listed