What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as trimodality therapy (TMT), radical cystectomy, and intravesical therapies like gemcitabine, have various side effects. TMT can lead to urinary-irritative symptoms, bowel symptoms, and late pelvic toxicity, with a small percentage experiencing severe genitourinary or gastrointestinal toxicity. Radical cystectomy may result in urinary retention, incontinence, and bowel dysfunction. Intravesical therapies like gemcitabine are generally well-tolerated but can cause local bladder irritation. Chemoresection treatments may have fewer clinically significant side effects but still require further investigation for long-term effects.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of bladder cancer, particularly for advanced or metastatic stages. Notable among these are immune checkpoint inhibitors like atezolizumab and pembrolizumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. Additionally, enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, has shown efficacy in patients who have progressed after platinum-based chemotherapy and checkpoint inhibitors. Erdafitinib, a pan-FGFR inhibitor, is approved for patients with FGFR genetic alterations. These treatments represent significant advancements in the management of bladder cancer, offering new options for patients with advanced disease.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment in 2024 include: 1) Erdafitinib, an FGFR inhibitor, showing efficacy in locally advanced or metastatic urothelial carcinoma. 2) Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, effective in patients previously treated with platinum and checkpoint inhibitors. 3) Sacituzumab Govitecan, another antibody-drug conjugate, for patients progressing after platinum-based chemotherapy and checkpoint inhibitors. 4) Immunotherapies such as Pembrolizumab and Nivolumab, which have shown long-term survival benefits in advanced urothelial carcinoma. These alternatives offer new hope for patients, especially those who are ineligible for traditional chemotherapy.

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Tyrosine Kinase Inhibitor

Erdafitinib Delivery System for Bladder Cancer

Phase 1

Recruiting

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new way to deliver a drug called Erdafitinib directly into the bladder for patients with certain types of bladder cancer. These patients have genetic changes that make their cancer harder to treat. The drug works by blocking proteins that help the cancer grow. The goal is to find the best dose and see how well it works and how safe it is.

Who is the study for?

This trial is for people with recurrent bladder cancer that hasn't spread into muscle or has just started to. They must have a specific genetic change in their tumor and may or may not have had BCG therapy, depending on the group they're placed in. Surgery should be an option for some participants. Those who've had recent pelvic radiation, certain bladder conditions, permanent urinary catheters, or previous FGFR inhibitor treatments can't join.

What is being tested?

The study is testing Erdafitinib Intravesical Delivery System directly applied inside the bladder. The first part of the trial will find the best dose to use while the second part checks how safe it is at that dose.

What are the potential side effects?

While specific side effects aren't listed here, intravesical therapies can generally cause discomfort during administration, increased frequency of urination, pain when urinating, blood in urine and potential risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with AEs by Severity

Number of Participants with Adverse Events (AEs)

Number of Participants with Dose-limiting Toxicity (DLT)

Secondary study objectives

Cohort 3 and 5: Complete Response (CR) Rate

Cohort 3 and 5: Duration of CR

Administration, Intravesical

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3: RP2D Dose ExpansionExperimental Treatment1 Intervention

Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.

Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.

Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D\[s\]) for Part 2.

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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 surgery, chemotherapy, radiation therapy, and emerging targeted therapies. Surgery, such as radical cystectomy, involves removing the bladder to eliminate cancerous tissue. Chemotherapy uses drugs like cisplatin to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. Emerging targeted therapies, including those studied in clinical trials, focus on specific molecular targets within cancer cells, such as FGFR inhibitors like erdafitinib, to block pathways that promote cancer growth. These treatments are crucial as they offer different mechanisms to control or eradicate cancer, providing options tailored to the patient's specific condition and improving overall outcomes.

[The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.