What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as intravesical drug delivery systems and immune checkpoint inhibitors, have distinct side effects. Intravesical therapies often cause local bladder irritation, urinary frequency, urgency, and dysuria, with occasional systemic effects like fatigue. Immune checkpoint inhibitors, like cetrelimab, can lead to immune-related adverse events including fatigue, rash, diarrhea, and more severe conditions like pneumonitis, hepatitis, and colitis. Combining these treatments may result in both local bladder irritation and systemic immune-related effects.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer, including immune checkpoint inhibitors and localized drug delivery systems. Pembrolizumab and atezolizumab are anti-PD-1 and anti-PD-L1 monoclonal antibodies, respectively, approved for advanced urothelial carcinoma. These drugs enhance the immune response against cancer cells. Additionally, localized treatments like intravesical Bacillus Calmette-Guérin (BCG) therapy are used for non-muscle invasive bladder cancer, delivering medication directly into the bladder. These treatments share similarities with the TAR-200 and cetrelimab combination being studied, focusing on enhancing immune response and localized drug delivery.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment in 2024 include: 1) Oncofid-P-B, a novel compound with specific binding to the CD44 receptor, showing high efficacy and safety in BCG-unresponsive carcinoma in situ (CIS) of the bladder. 2) Avelumab, a PD-L1 inhibitor, used as switch maintenance therapy in metastatic urothelial cancer, demonstrating improved overall survival. 3) Enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, effective in previously treated advanced urothelial carcinoma. 4) Erdafitinib, an oral pan-FGFR inhibitor, showing efficacy in patients with locally advanced or metastatic urothelial carcinoma with FGFR alterations.

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Monoclonal Antibodies

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

Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

Ineligible for or have elected not to undergo radical cystectomy

Must not have

Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization

Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include typical reactions related to immunotherapy such as fatigue, skin issues, inflammation of organs; chemotherapy-related nausea, hair loss; radiation therapy may cause local skin irritation and discomfort.

Eligibility Criteria

Inclusion Criteria

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

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

Select...

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

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

Select...

- Your bone marrow, liver, and kidney need to work well: - Your bone marrow should produce enough blood cells without the need for extra support. - You should have a certain level of white blood cells, platelets, and hemoglobin. - Your liver should function normally. - Your kidneys should filter your blood well.

Exclusion Criteria

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

Select...

My cancer has not spread to distant organs, nor is it in the most advanced local stages.

Select...

I do not have widespread early-stage bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event

Secondary study objectives

Metastasis-free survival (MFS)

Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)

Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)

+3 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

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.

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

TAR-200 is a localized drug delivery system that releases medication directly into the bladder, ensuring high local drug concentration and reducing systemic side effects. Cetrelimab, an anti-PD-1 monoclonal antibody, enhances the immune system's ability to target and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These mechanisms are significant for bladder cancer patients as they offer the potential for more effective and targeted treatments with fewer side effects compared to traditional systemic therapies.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.][The role of immunotherapy in the modern treatment of urothelial carcinoma].