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No longer recruiting (closed or complete)Last updated: 15 May 2024

SAUL: This phase III trial is assessing the safety of atezolizumab (an immunotherapy drug) as second line treatment for patients with advanced cancer of the urinary tractAn open label, single arm, multicentre, safety study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

SAUL

Clinical summary

Summary

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.

Conditions

This trial is treating people with urothelial or non-urothelial cancer of the urinary tract

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Hoffmann-La Roche

Scientific Title

An open label, single arm, multicentre, safety study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract

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