TAR-200 + Cetrelimab for Bladder Cancer
(SunRISe-1 Trial)

Recruiting in Palo Alto (17 mi)

+171 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?This trial is testing a drug-delivery device (TAR-200) and an immune-boosting drug (cetrelimab) in bladder cancer patients who have not responded well to other treatments. TAR-200 releases medicine directly into the bladder, while cetrelimab helps the immune system fight cancer. Cetrelimab is being studied in patients with different types of bladder cancer.

Eligibility Criteria

This trial is for adults with high-risk non-muscle invasive bladder cancer that hasn't responded to BCG therapy and who can't have or chose not to undergo bladder removal surgery. They should be mostly urothelial cancer type, without certain aggressive features, and must have a performance status that allows daily living activities.

Inclusion Criteria

I am able to care for myself and perform daily activities.

My bladder cancer did not respond to a full course of BCG treatment.

My tumor is mainly urothelial but doesn’t have certain aggressive features.

+5 more

Exclusion Criteria

I have not received a live virus vaccine in the last 30 days.

I don't have active hepatitis B or C, or it's undetectable.

My bladder cancer has not spread outside the bladder, except possibly for early-stage cancer in the upper urinary tract treated over 2 years ago.

+2 more

Participant Groups

The study tests TAR-200 (a drug-device combination) and Cetrelimab (an immunotherapy), alone or in combination, in four different participant groups based on their specific type of bladder cancer. The main goals are to see if the treatments completely remove the cancer or prevent it from returning.

4Treatment groups

Experimental Treatment

Group I: Cohort 4: TAR-200 (Participants with Papillary Disease only)Experimental Treatment1 Intervention

TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).

Group II: Cohort 3: CetrelimabExperimental Treatment1 Intervention

Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).

Group III: Cohort 2: TAR-200Experimental Treatment1 Intervention

TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).

Group IV: Cohort 1: TAR-200 and CetrelimabExperimental Treatment2 Interventions

TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).