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

This study is currently recruiting participants.
Verified December 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT02928406
First Posted: October 10, 2016
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.

Condition Intervention Phase
Urinary Tract Cancer Drug: Atezolizumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to end of study (up to approximately 6 years) ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization until death from any cause (up to approximately 6 years) ]
  • Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1 [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Percentage of Participants With Best Overall Response as Assessed by Modified RECIST [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Percentage of Participants With Disease Control as Assessed by RECIST v1.1 [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Percentage of Participants With Disease Control as Assessed by Modified RECIST [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Duration of Response as Assessed by RECIST v1.1 [ Time Frame: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Duration of Response as Assessed by Modified RECIST [ Time Frame: Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first (up to approximately 6 years) ]
  • Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days) ]
  • Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score [ Time Frame: Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days) ]

Estimated Enrollment: 1000
Actual Study Start Date: November 30, 2016
Estimated Study Completion Date: May 31, 2022
Estimated Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab
Participants will receive atezolizumab every 3 weeks (Q3W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Drug: Atezolizumab
Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.
Other Name: MPDL3280A

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with 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
  • Participants with measurable and/or non-measurable disease according to RECIST v1.1
  • Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
  • If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
  • Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2

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

    1. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
    2. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
  • Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
  • Significant renal disorder indicating a need for renal transplant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928406


Contacts
Contact: Reference Study ID Number: MO29983 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 198 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02928406     History of Changes
Other Study ID Numbers: MO29983
2016-002625-11 ( EudraCT Number )
First Submitted: October 7, 2016
First Posted: October 10, 2016
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs