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

• Register: CTRI
• Last refreshed on: 21 November 2022
• Main ID: CTRI/2017/08/009196
• Date of registration: 01-08-2017
• Prospective Registration: Yes
• Primary sponsor: F HoffmanLa Roche Ltd
• Public title: 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. - SAUL
• Date of first enrolment: 29-09-2017
• Target sample size: 1000
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19094
• Study type: Interventional
• Study design: Single Arm Study Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

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

• Name: Dr Viraj Suvarna
• Affiliation: Roche Products (India) Pvt. Ltd.

• Name: Priyanka Bhattacharya
• Affiliation: Roche Products (India) Pvt. Ltd.

Key inclusion & exclusion 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: 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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 applicable: Not applicable

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

MO29983 Protocol version 13.0 dated 03 Mar 2021

Source(s) of Monetary Support

Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai - 400 086 Maharashtra ,India

Secondary Sponsor(s)

Roche Products India Pvt Ltd

Ethics review

Status: Approved
Approval date: 18/05/2017
Contact:

HCG Multi Speciality Ethics Committee

Status: Approved
Approval date: 10/07/2017
Contact:

Artemis Health Sciences Institutional Ethics Committee

Status: Approved
Approval date: 21/09/2017
Contact:

Institutional Ethics Committee Max Super Speciality hospital A Unit of Devaki Devi Foundation

Status: Approved
Approval date: 23/10/2017
Contact:

Institutional Ethics Committee, Tata Memorial Centre, Mumbai

Status: Approved
Approval date: 05/05/2021
Contact:

Institutional Review Board, Tata Medical Center, Kolkata