What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as Enfortumab Vedotin, which is an antibody-drug conjugate targeting Nectin-4, can cause side effects including fatigue, peripheral neuropathy, rash, and gastrointestinal issues like nausea and diarrhea. Chemotherapy regimens, often used in bladder cancer, can lead to neutropenia, increased risk of infection, hair loss, and organ toxicity. Immunotherapy, another common treatment, may cause immune-related adverse events such as colitis, hepatitis, and endocrinopathies. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What other types of research exist?

Promising novel alternatives to Enfortumab Vedotin for bladder cancer patients in 2024 include: 1) Immune checkpoint inhibitors such as Pembrolizumab and Nivolumab, which have shown efficacy in advanced urothelial carcinoma. 2) Combination therapies like Nivolumab plus Ipilimumab, which are being explored for enhanced efficacy. 3) Targeted therapies including Erdafitinib, a FGFR inhibitor, for patients with specific genetic alterations. 4) Other antibody-drug conjugates under investigation, such as Sacituzumab Govitecan, targeting Trop-2.

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Antibody-drug conjugate

Enfortumab Vedotin for Bladder Cancer

Q: What prior FDA approvals exist?

Enfortumab Vedotin is an antibody-drug conjugate targeting Nectin-4, approved for the treatment of advanced urothelial carcinoma, a common type of bladder cancer. Other notable FDA-approved treatments for bladder cancer include immune checkpoint inhibitors such as Pembrolizumab and Atezolizumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. These therapies are typically used in patients who have progressed on platinum-based chemotherapy or are ineligible for such treatments.

Phase 2

Recruiting

Led By Min Yuen Teo, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

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 up to 2 years

Awards & highlights

Summary

This trial is testing enfortumab vedotin, a drug that targets and kills cancer cells, in patients with upper urinary tract urothelial carcinoma who can't or won't use cisplatin and are planning surgery. Enfortumab vedotin is a new type of drug that targets a specific protein on cancer cells and delivers a substance that kills these cells.

Who is the study for?

This trial is for adults with high-grade urothelial carcinoma of the upper urinary tract who can't or choose not to take cisplatin and are planning on having surgery. They should have adequate kidney function, hearing loss no worse than Grade 2, a good performance status, stable blood counts and liver enzymes, and not be pregnant or breastfeeding. People with uncontrolled diabetes, recent major surgery, active heart disease or infections like tuberculosis or hepatitis B/C cannot join.

What is being tested?

The study is testing Enfortumab Vedotin's effectiveness and safety in treating cancer before patients undergo standard radical surgery to remove their tumors. It targets those who aren't eligible for cisplatin chemotherapy.

What are the potential side effects?

Enfortumab Vedotin may cause side effects such as fatigue, hair loss, skin rash, decreased appetite, changes in taste sensation, neuropathy (nerve pain), nausea/vomiting/diarrhea/constipation; it also has potential risks of infusion reactions and blood cell count changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Proportion of patients who achieve pathologic complete response

Secondary study objectives

The rate of grade 3 - 4 toxicity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Enfortumab VedotinExperimental Treatment2 Interventions

All patients will receive enfortumab vedotin at 1.25 g/kg on days 1 and 8 of 21 days cycle, for a total of three cycles, followed by radical nephroureterectomy, ureterectomy, or nephrectomy, depending on the site of the tumor and per the clinical decision of the treating urologist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical surgery

2020

Completed Phase 1

~50

Do I qualify?Apply below to find out

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 often include antibody-drug conjugates (ADCs) like Enfortumab Vedotin, which target specific proteins (e.g., Nectin-4) on cancer cells to deliver cytotoxic agents directly, minimizing damage to healthy cells. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, enhance the immune system's ability to recognize and attack cancer cells by blocking proteins that inhibit immune responses. Traditional chemotherapies, like cisplatin and gemcitabine, work by interfering with cell division, leading to cancer cell death. These treatments are crucial as they offer targeted, effective options that can improve survival rates and quality of life for bladder cancer patients.

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,532 Total Patients Enrolled

Astellas Pharma US, Inc.Industry Sponsor

88 Previous Clinical Trials

12,813 Total Patients Enrolled

Min Yuen Teo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05868265 — Phase 2

Bladder Cancer Research Study Groups: Enfortumab Vedotin

Bladder Cancer Clinical Trial 2023: Enfortumab Vedotin Highlights & Side Effects. Trial Name: NCT05868265 — Phase 2

Enfortumab Vedotin (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868265 — Phase 2

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