Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 February 2024 |
Main ID: |
EUCTR2016-002625-11-PT |
Date of registration:
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22/12/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non Urothelial Carcinoma of the Urinary Tract
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Scientific title:
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AN OPEN LABEL, SINGLE ARM, MULTICENTER, SAFETY STUDY OF ATEZOLIZUMAB IN LOCALLY ADVANCED OR METASTATIC UROTHELIAL OR NON-UROTHELIAL CARCINOMA OF THE URINARY TRACT |
Date of first enrolment:
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12/01/2017 |
Target sample size:
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1000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002625-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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Colombia
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Croatia
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Czech Republic
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Czechia
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Denmark
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Egypt
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Estonia
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Lithuania
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Netherlands
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Poland
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Portugal
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Romania
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Russian Federation
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Saudi Arabia
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Slovakia
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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+4161 688 1111 |
Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd. |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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+4161 688 1111 |
Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: - 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
Exclusion criteria: - Treatment with more than three prior lines 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) f
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract MedDRA version: 21.1
Level: PT
Classification code 10059515
Term: Non-small cell lung cancer metastatic
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Atezolizumab Product Code: RO5541267/F03 Pharmaceutical Form: Solution for infusion INN or Proposed INN: ATEZOLIZUMAB CAS Number: 1380723-44-3 Current Sponsor code: RO5541267 Other descriptive name: MPDL3280A, Tecentriq Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60-
Trade Name: Tecentriq Product Name: Atezolizumab Product Code: RO5541267 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ATEZOLIZUMAB CAS Number: 1380723-44-3 Current Sponsor code: RO5541267 Other descriptive name: MPDL3280A, Tecentriq Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentration number: 60-
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Primary Outcome(s)
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Primary end point(s): 1.Nature, severity, duration, frequency and timing of adverse events 2.Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab administration
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Main Objective: To evaluate the safety of atezolizumab
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Timepoint(s) of evaluation of this end point: 1-2. Up to 6 years
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Secondary Objective: To evaluate the efficacy of atezolizumab
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Secondary Outcome(s)
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Secondary end point(s): 1.Overall survival (OS) 2.Progression-free survival (PFS) 3.Overall response rate (ORR) 4.Disease control rate (DCR) 5.Duration of response (DoR) 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) 7.EuroQol EQ-5D-5L-assessed health utility score
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Timepoint(s) of evaluation of this end point: 1-7. Up to 6 years
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Secondary ID(s)
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2016-002625-11-GR
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MO29983
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd.
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Ethics review
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Status: Approved
Approval date: 09/01/2017
Contact:
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