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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.
See Contacts and Locations
Verified June 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02928406
First received: October 7, 2016
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
This multicenter study will assess the safety of atezolizumab as second-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: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse event [ Time Frame: Baseline up to approximately 6 years ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization up to death by 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, 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, 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, whichever occurs first (up to approximately 6 years) ]
  • Duration of Response as Assessed by RECIST v1.1 [ Time Frame: 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 EuroQoL (European Quality of Life) Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L) 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 until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participants decision to withdraw from therapy, or death (whichever occurs first).
Drug: Atezolizumab
Participants will receive 1200 milligrams of atezolizumab by intravenous infusion every 3 weeks until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participants decision to withdraw from therapy, or death (whichever occurs first).
Other Name: MPDL3280A

  Eligibility

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 non-measurable disease according to RECIST v1.1
  • Must have received one prior combination chemotherapy regimen for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block
  • Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2

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
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
  • Significant renal disorder requiring dialysis or indication for renal transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 196 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
Study First Received: October 7, 2016
Last Updated: June 16, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017