What is the mechanism of action of this treatment?

The most common treatments for bladder cancer include chemotherapy, immunotherapy, and surgical interventions. TAR-200, a drug delivery system, provides sustained release of chemotherapy directly to the bladder, maximizing local drug concentration and minimizing systemic side effects. Cetrelimab, an immunotherapy agent, is a PD-1 inhibitor that enhances the immune system's ability to detect and destroy cancer cells. These targeted treatments are crucial for bladder cancer patients as they offer potentially more effective and safer alternatives to traditional therapies.

What side effects are associated with this type of intervention?

The most common treatments for bladder cancer, such as drug delivery systems like TAR-200 and immunotherapies like Cetrelimab, have distinct side effect profiles. TAR-200, being a localized drug delivery system, may cause local irritation, urinary tract infections, and bladder discomfort. Cetrelimab, an immunotherapy, can lead to immune-related side effects including fatigue, rash, diarrhea, and more severe conditions like pneumonitis, colitis, and hepatitis. General chemotherapy side effects include nausea, vomiting, hair loss, and increased risk of infections due to bone marrow suppression.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that are similar to TAR-200 and cetrelimab. For drug delivery systems, there is no direct mention of a similar system to TAR-200 in the provided context. However, for immunotherapy, the FDA has approved immune checkpoint inhibitors like pembrolizumab and atezolizumab for advanced urothelial carcinoma. Pembrolizumab, for instance, is used for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. Atezolizumab is another checkpoint inhibitor approved for similar indications. These treatments work by targeting the PD-1/PD-L1 pathway, similar to cetrelimab.

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 advanced urothelial carcinoma. 2) Erdafitinib, an FGFR inhibitor, effective in patients with specific genetic alterations. 3) Sacituzumab Govitecan, another antibody-drug conjugate targeting Trop-2, for patients progressing after chemotherapy and checkpoint inhibitors. 4) Atezolizumab, a PD-L1 inhibitor, used as first-line treatment in cisplatin-ineligible patients. These treatments offer new mechanisms of action and have shown promising results in clinical trials.

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Monoclonal Antibodies

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

Phase 2

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

BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course

Must not have

Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)

Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions related to immunotherapies such as fatigue, skin reactions, inflammation of organs like lungs or intestines, hormonal gland problems, liver issues, and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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My bladder cancer has not invaded the muscle layer.

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

Exclusion Criteria

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

Select...

My bladder cancer is advanced and cannot be surgically removed.

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I have been treated with drugs targeting immune checkpoints.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Cohort 1, 2, and 3: Overall Complete Response (CR) Rate

Cohort 4: Disease-free Survival (DFS)

Secondary study objectives

Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores

Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAR-200

2017

Completed Phase 1

~40

Cetrelimab

2022

Completed Phase 1

~20

0 / 7Eligibility 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

The most common treatments for bladder cancer include chemotherapy, immunotherapy, and surgical interventions. TAR-200, a drug delivery system, provides sustained release of chemotherapy directly to the bladder, maximizing local drug concentration and minimizing systemic side effects. Cetrelimab, an immunotherapy agent, is a PD-1 inhibitor that enhances the immune system's ability to detect and destroy cancer cells. These targeted treatments are crucial for bladder cancer patients as they offer potentially more effective and safer alternatives to traditional therapies.

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