TAR-200 + Cetrelimab for Bladder Cancer
(SunRISe-4 Trial)

Recruiting in Palo Alto (17 mi)

+137 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

Eligibility Criteria

This trial is for adults with muscle-invasive bladder cancer that hasn't spread beyond the bladder and who haven't had systemic chemotherapy or radiation recently. They should be in good physical condition (ECOG 0-1) and have normal thyroid function or stable hormone levels. Tumors must be predominantly urothelial, not larger than 3cm after surgery, and participants must be fit for radical cystectomy.

Inclusion Criteria

My urologist says I can and should have radical cystectomy.

Your thyroid tests are normal, or if you are taking thyroid medication, it's working well for you. If the test results are unclear, a specialist may be consulted to decide if you can participate.

My bladder cancer was diagnosed within the last 4 months and is not spread to other parts.

+3 more

Exclusion Criteria

I have had chemotherapy for bladder cancer before.

I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.

I haven't been in a clinical trial for a new treatment or device in the last 4 weeks.

+3 more

Participant Groups

The study tests TAR-200 inserted into the bladder combined with cetrelimab given through IV, versus cetrelimab alone via IV. The goal is to see which treatment better reduces tumor size or prevents cancer from returning.

2Treatment groups

Experimental Treatment

Group I: Cohort 2: CetrelimabExperimental Treatment1 Intervention

Participants will receive cetrelimab.

Group II: Cohort 1: TAR-200 + CetrelimabExperimental Treatment2 Interventions

Participants will receive TAR-200 in combination with cetrelimab.