What side effects are associated with this type of intervention?

Common treatments for bladder cancer include intravesical chemotherapy, systemic chemotherapy, immunotherapy, and targeted therapies such as FGFR inhibitors. Intravesical chemotherapy can cause bladder irritation, frequent urination, and hematuria. Systemic chemotherapy often leads to nausea, vomiting, hair loss, and increased risk of infection. Immunotherapy side effects include fatigue, rash, and autoimmune reactions. FGFR inhibitors like Erdafitinib can cause hyperphosphatemia, dry mouth, fatigue, and eye disorders such as central serous retinopathy. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Erdafitinib is an FGFR inhibitor used for treating bladder cancer, specifically targeting fibroblast growth factor receptor (FGFR) mutations or fusions. Other FDA-approved treatments for bladder cancer include immune checkpoint inhibitors like pembrolizumab and atezolizumab, which are used for advanced urothelial carcinoma. Additionally, chemotherapy regimens such as gemcitabine and cisplatin are commonly used. These treatments offer various mechanisms of action, from targeting specific genetic mutations to enhancing the immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to Erdafitinib for bladder cancer patients include Pembrolizumab, Atezolizumab, and Enfortumab Vedotin. Pembrolizumab and Atezolizumab are immune checkpoint inhibitors that have shown efficacy in advanced urothelial carcinoma. Enfortumab Vedotin is an antibody-drug conjugate targeting Nectin-4, which has demonstrated significant activity in patients previously treated with platinum-based chemotherapy and checkpoint inhibitors.

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Tyrosine Kinase Inhibitor

Erdafitinib vs Chemotherapy for Bladder Cancer

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

Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed

Must not have

Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder

Prior treatment with an FGFR inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests erdafitinib, a pill that targets proteins to stop cancer growth, in patients with a type of bladder cancer that has returned after standard treatment. The drug blocks signals that help cancer cells grow. Erdafitinib is approved for treating a specific type of advanced bladder cancer.

Who is the study for?

This trial is for adults with high-risk non-muscle-invasive bladder cancer that has returned after BCG therapy. Participants must have specific FGFR mutations or fusions, be unable to undergo cystectomy, and have good performance status (ECOG 0-1). They need proper organ function and a negative pregnancy test for women of childbearing potential.

What is being tested?

The study compares the effectiveness of Erdafitinib against standard intravesical chemotherapy drugs like Gemcitabine or Mitomycin C in preventing cancer recurrence. It targets patients whose bladder cancer harbors certain genetic changes and who didn't respond well to previous treatments.

What are the potential side effects?

Erdafitinib may cause side effects such as mouth sores, nail changes, skin rash, dry skin, change in hair color, tiredness, diarrhea and loss of appetite. Standard chemotherapy can lead to irritation inside the bladder, bleeding when urinating or increased frequency of urination.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My bladder cancer has come back and is not in the muscle.

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My bladder cancer did not respond to BCG therapy.

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My tumor has specific FGFR gene changes.

Exclusion Criteria

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

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My bladder cancer is a specific type, like small cell or squamous.

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I have been treated with an FGFR inhibitor before.

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My bladder cancer is invasive and confirmed by a tissue examination.

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I have a current eye condition affecting my retina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Recurrence-Free Survival (RFS)

Secondary study objectives

Number of Participants with Adverse events

Overall Survival

Plasma Concentration of Erdafitinib

+2 more

Side effects data

From 2024 Phase 1 trial • 35 Patients • NCT03238196

83%

Fatigue

83%

Oral mucositis

67%

Dysgeusia

67%

Neutrophil decreased

67%

Urinary tract infection

67%

Dry mouth

67%

Dry skin

50%

Epistaxis

50%

Palmar-plantar erythrodysesthesia

50%

Sore throat

50%

Diarrhea

50%

Anorexia

33%

Dyspesia

33%

Hyperparathyroidism

33%

Dry eyes

33%

Constipation

33%

Platelet count decreased

33%

Anemia

33%

Dyspnea

33%

Vomiting

17%

Urinary tract pain

17%

Limb edema

17%

Dehydration

17%

Pain extremity

17%

Pulmonary embolism

17%

Muscle weakness

17%

Pruritus

17%

Cough

17%

Anxiety

17%

Hemorrhoids

17%

Rectal hemorrhage

17%

White blood cell decreased

17%

Rash maculo-paular

17%

Nasal congestion

17%

Blurred vision

17%

Bruising

17%

Nausea

17%

Dental caries

17%

Creatinine increased

17%

Non-cardiac chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Fulvestrant 500mg/Palbociclib 125mg/Erdafitinib 6mg

Fulvestrant 500mg, Palbociclib 125mg and Erdafitinib 8mg

Fulvestrant 500mg/Palbociclib 125mg/Erdafitinib 5mg

Expansion

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

Active Control

Group I: Cohort 3Experimental Treatment1 Intervention

Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.

Group II: Cohort 2Experimental Treatment1 Intervention

Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.

Group III: Cohort 1: ErdafitinibExperimental Treatment1 Intervention

Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ \[CIS\], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.

Group IV: Cohort 1: Investigators ChoiceActive Control2 Interventions

Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erdafitinib

2017

Completed Phase 2

~180

0 / 8Eligibility 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. FGFR inhibitors like erdafitinib block the fibroblast growth factor receptor pathways, which are often mutated in bladder cancer, thereby inhibiting tumor growth. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while immunotherapy boosts the body's immune system to recognize and attack cancer cells. Radiation therapy uses high-energy rays to damage the DNA of cancer cells, leading to cell death. Understanding these mechanisms is crucial for bladder cancer patients as it helps in selecting the most effective treatment based on the specific characteristics of their cancer.

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