A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non Urothelial Carcinoma of the Urinary Tract
- Conditions
- Advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tractMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002625-11-IT
- Lead Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1000
- Age >= 18 years
- Histologically documented locally advanced (tumor (T) 4b, any node (N); or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
- Patients with measurable and non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 are allowed
- Must have received one prior combination chemotherapy regimen (e.g., methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], gemcitabine and cisplatin [GC], etc.) for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block available for submission at baseline
- Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
- Life expectancy >= 12 weeks
- Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 2 weeks prior to the first study treatment
- Patients with treated, asymptomatic central nervous system (CNS) metastases are eligible (Note: Patients on stable doses of anticonvulsants or on prednisone doses [or dose equivalents] of <= 20 milligram/day are allowed)
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700
- Treatment with more than three prior line of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- Treatment with 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)
- Pregnant or lactating, or intending to become pregnant during the study
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
- Significant cardiovascular disease, such as New York Heart Association cardiac disease >= Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
- Significant renal disorder requiring dialysis or indication for renal transplant
- Signs or symptoms of severe infection within 2 weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- 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
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis (including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- 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 cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, including anti- cytotoxic T lymphocyte-associated (CTLA)-4, anti- programmed cell death protein 1 (PD-1), and anti- programmed death-ligand 1 (PD-L1) therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) 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. Note: For patients with autoimmune disease, immunosuppressive medications are permitted if the patient has controlled autoimmune disease and stable treatment (i.e., same treatment, same dose) fo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety of atezolizumab;Secondary Objective: To evaluate the efficacy of atezolizumab ;Primary end point(s): 1.Nature, severity, duration, frequency and timing of adverse events<br>2.Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab administration;Timepoint(s) of evaluation of this end point: 1-2. Up to 6 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Overall survival (OS)<br>2.Progression-free survival (PFS)<br>3.Overall response rate (ORR)<br>4.Disease control rate (DCR)<br>5.Duration of response (DoR)<br>6.Change from baseline in health-related quality of life (HRQoL), as assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30)<br>7.EuroQol EQ-5D-5L-assessed health utility score;Timepoint(s) of evaluation of this end point: 1-7. Up to 6 years