What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as gemcitabine and PD-1 inhibitors like cetrelimab, have specific side effects. Intravesical gemcitabine can cause chemical cystitis, rash, and rarely, myelosuppression. PD-1 inhibitors may lead to immune-related adverse events including fatigue, rash, diarrhea, and more severe conditions like pneumonitis, colitis, and hepatitis. Combining these treatments may result in a combination of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that are similar to TAR-200 plus cetrelimab. Gemcitabine, which is released by TAR-200, has been used intravesically for non-muscle invasive bladder cancer due to its efficacy and favorable toxicity profile. Additionally, immune checkpoint inhibitors such as pembrolizumab (a PD-1 inhibitor) and atezolizumab (a PD-L1 inhibitor) have been approved for advanced urothelial carcinoma, enhancing the immune response against cancer cells. These approvals highlight the evolving landscape of bladder cancer treatment, combining localized chemotherapy with systemic immunotherapy.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment in 2024 include: 1) Enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, which has shown efficacy in patients previously treated with PD-1/PD-L1 inhibitors. 2) Erdafitinib, a pan-FGFR inhibitor, effective in patients with FGFR genetic alterations. 3) Pembrolizumab, a PD-1 inhibitor, which has demonstrated long-term benefits in various settings, including as a first-line treatment for cisplatin-ineligible patients. 4) Atezolizumab, a PD-L1 inhibitor, used as first-line treatment in cisplatin-ineligible patients and showing durable responses.

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Virus Therapy

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

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)

Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve

Must not have

A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)

Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years 2 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include immune-related reactions due to cetrelimab, irritation or discomfort from TAR-200 device use, and typical local reactions associated with BCG such as pain during urination or blood in urine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My bladder cancer is aggressive but hasn't spread into the muscle, and I haven't had BCG treatment.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My bladder cancer is advanced and cannot be surgically removed.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free Survival (EFS)

Secondary study objectives

Cancer Specific Survival (CSS)

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24

Duration of CR

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetrelimab

2022

Completed Phase 1

~20

TAR-200

2017

Completed Phase 1

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments work through various mechanisms to target and destroy cancer cells. TAR-200 releases gemcitabine directly into the bladder, providing localized chemotherapy that minimizes systemic side effects. Cetrelimab, a PD-1 inhibitor, enhances the immune system's ability to recognize and attack cancer cells. Intravesical BCG, another common treatment, stimulates the immune system to fight cancer within the bladder. Systemic chemotherapy, often used for advanced stages, targets rapidly dividing cells throughout the body. Understanding these mechanisms helps patients and doctors choose the most effective treatment strategy, balancing efficacy with potential side effects.

Combination of cyclin-dependent kinase and immune checkpoint inhibitors for the treatment of bladder cancer.[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.][The role of immunotherapy in the modern treatment of urothelial carcinoma].