TAR-200 + Cetrelimab vs BCG for Bladder Cancer
(SunRISe-3 Trial)

Recruiting in Palo Alto (17 mi)

+374 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new bladder cancer treatment using a special device to deliver a drug directly into the bladder, either alone or with an immune-boosting drug. It targets patients with high-risk bladder cancer who haven't had BCG treatment before. The device ensures a steady release of the drug, while the immune-boosting drug helps the body fight cancer.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for individuals with high-risk non-muscle invasive bladder cancer who haven't had BCG therapy before. They should be in good enough health to participate, have no muscle-invasive or metastatic cancer, and not have significant urinary tract abnormalities that could interfere with treatment.

Inclusion Criteria

All visible signs of my bladder cancer have been surgically removed.

All side effects from my previous treatments have mostly gone away.

I have never had BCG therapy or stopped it over 3 years ago.

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Exclusion Criteria

I have a history of urinating more than usual, with over 4 liters in a day.

My bladder cancer is advanced and cannot be surgically removed.

I do not have a permanent catheter, but I may use one temporarily.

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Treatment Details

Interventions

BCG Vesiculture (Virus Therapy)
Cetrelimab (Monoclonal Antibodies)
TAR-200 (Virus Therapy)

Trial OverviewThe study compares the effectiveness of TAR-200 combined with cetrelimab (Group A) and TAR-200 alone (Group C) against intravesical BCG therapy (Group B). The main goal is to see which group stays free from cancer events longer.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Group C: TAR-200 AloneExperimental Treatment1 Intervention

Participants will receive intravesical TAR-200 alone once Q3W.

Group II: Treatment Group A: TAR-200 + CetrelimabExperimental Treatment2 Interventions

Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.

Group III: Treatment Group B: Bacillus Calmette-Guerin (BCG) VesicultureActive Control1 Intervention

Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).