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

Sponsor
Hoffmann-La Roche
Study ID
NCT02928406
Phase
PHASE3
Status
Completed

Conditions

  • Urinary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Mar 2024
Primary completion
Dec 12, 2022
Completion
Dec 12, 2022

Study Design

Enrollment
1,004 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

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

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