TAR-200 + Cetrelimab vs Chemoradiotherapy for Bladder Cancer
(SunRISe-2 Trial)

Recruiting in Palo Alto (17 mi)

+377 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 treatment for bladder cancer that combines a device delivering medication directly to the bladder with a drug that helps the immune system fight cancer. The goal is to see if this combination works better than the usual treatment in keeping the bladder free from cancer events.

Eligibility Criteria

This trial is for adults with muscle-invasive bladder cancer who can't have or chose not to get radical cystectomy. They should be relatively active (ECOG 0-2), recovered from previous treatments, and have normal thyroid function plus good bone marrow, liver, and kidney health.

Inclusion Criteria

Your thyroid test results are normal, or if you're taking medication for your thyroid, it's stable. If your test results are not clear, a specialist may be consulted to decide if you can participate.

I can take care of myself but might not be able to do heavy physical work.

I have chosen not to or cannot have major bladder surgery.

+2 more

Exclusion Criteria

My bladder was accidentally punctured during a bladder exam but has since healed.

My bladder cancer has not spread outside the bladder, except for specific treated cases over 2 years ago.

You have a bladder or urethral feature that could make it difficult or unsafe to use the TAR 200 device.

+2 more

Participant Groups

The study compares the effectiveness of TAR-200 combined with cetrelimab against standard chemoradiotherapy in preserving the bladder. Participants are randomly assigned to either treatment group to measure which approach is better at preventing cancer progression.

2Treatment groups

Experimental Treatment

Active Control

Group I: TAR-200 + CetrelimabExperimental Treatment2 Interventions

Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with intravenous (IV) Cetrelimab.

Group II: Chemotherapy (cisplatin or gemcitabine) + Radiation TherapyActive Control4 Interventions

Participants will receive chemotherapy based on investigator's choice from either cisplatin intravenously once weekly for 4 to 6 treatment weeks or gemcitabine intravenously twice weekly for 4 to 6 treatment weeks as Standard of Care (SOC) along with radiation therapy from either conventional radiotherapy (64 Gray \[Gy\], bladder only) for up to 6.5 treatment weeks or hypo-fractionated radiotherapy (55 Gy, bladder only) for up to 4 weeks.