A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non Urothelial Carcinoma of the Urinary Tract

• Register: EUCTR
• Last refreshed on: 4 March 2024
• Main ID: EUCTR2016-002625-11-LT
• Date of registration: 13/12/2016
• Prospective Registration: Yes
• Primary sponsor: F. Hoffman-La Roche Ltd.
• Public title: A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non Urothelial Carcinoma of the Urinary Tract
• Scientific title: 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: 16/01/2017
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002625-11
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

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
- 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 tre

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
MedDRA version: 20.0 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)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Main Objective: To evaluate the safety of atezolizumab

Timepoint(s) of evaluation of this end point: 1-2. Up to 6 years

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

Secondary Objective: To evaluate the efficacy of atezolizumab

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: 1-7. Up to 6 years

Secondary ID(s)

2016-002625-11-GR

MO29983

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date: 22/12/2016
Contact:

Results

• Results available: Yes
• Date Posted: 27/12/2023
• Date Completed: 12/12/2022
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002625-11/results