Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

SunRISe-2 : A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemBladder,Urothelial

Trial Overview Read MoreRead more

This phase III trial is evaluating the effectiveness of TAR-200, an intravesical drug-delivery system that involves administering treatment into the bladder directly, in combination with a targeted therapy in patients with muscle-invasive urothelial bladder cancer who are not receiving surgery to remove the bladder.
 

This trial is treating patients with urothelial bladder cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

Scientific Title

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Commercial Sponsor

Janssen Research & Development, LLC

Summary

This trial includes a screening phase (42 days), a treatment phase and a follow up phase. The total duration of the trial is up to 8 years. For the treatment phase of the trial, participants will be randomly allocated to one of two arms. In the experimental arm, participants will receive intravesical (meaning, within the bladder) TAR-200 every 3-weeks for the first 18 weeks and every 12 weeks from week 24 through to Year 3, in combination with Cetrelimab. Participants not allocated to the experimental arm will receive either cisplatin or gemcitabine chemotherapy (as chosen by the investigator) for 6-weeks, along with radiotherapy for up to 4-weeks.

Recruiting Hospitals Read MoreRead more

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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