InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 11 April 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

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 patients with urothelial or non-urothelial cancer of the urinary tract.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

SAUL

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.