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Antibody-Drug Conjugate

Enfortumab Vedotin + Pembrolizumab for Advanced Bladder Cancer

Phase 2

Recruiting

Led By Bassel Nazha, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically documented pure variant histology (nested, microcytic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell) bladder cancer and non-urothelial bladder cancer of epithelial origin including: pure squamous cell carcinoma and pure adenocarcinoma (urachal and non-urachal). Variant histology tumors and non-urothelial tumors of ureter, urethra, urachus, or renal pelvis are included. All histological classifications will follow the 2016 World Health Organization (WHO) classifications

Age >= 18 years

Must not have

Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 6 months prior to first dose of EV/pembrolizumab

Patients with ongoing sensory or motor neuropathy grade >= 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a targeted drug and immunotherapy to treat advanced bladder cancer of rare types.

Who is the study for?

Adults with advanced or metastatic bladder cancer of variant histology, who are fit (ECOG <=1), have not had recent treatments that could interfere, and can provide tumor samples. Women must not be pregnant and all participants must agree to use contraception. Exclusions include certain other cancers, uncontrolled illnesses, prior EV or PD-1/PD-L1 inhibitor treatment, active infections like hepatitis B/C, autoimmune diseases requiring systemic treatment within 2 years.

What is being tested?

The trial is testing the combination of Enfortumab Vedotin (EV) and Pembrolizumab in treating less common types of bladder cancer that has spread. EV targets nectin-4 on cancer cells to deliver a drug that kills them; Pembrolizumab helps the immune system fight cancer.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, fatigue, nausea, skin rash from enfortumab vedotin; pembrolizumab might cause immune-related issues such as inflammation in organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

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

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My bladder cancer is of a specific type, not the usual kind.

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I am 18 years old or older.

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I am mostly active and can care for myself.

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My cancer has spread or cannot be removed by surgery.

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I have either not been treated or have received multiple treatments.

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I can provide tumor samples or agree to a biopsy before starting the study.

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My cancer can be measured by scans according to specific criteria.

Exclusion Criteria

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

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I have not had serious heart problems like heart failure or unstable angina in the last 6 months.

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I have moderate to severe numbness, tingling, or muscle weakness.

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I have diabetes with an HbA1c level of 7% or higher and symptoms like frequent urination or thirst.

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I am on antibiotics for an infection or taking high dose steroids.

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My cancer is not a sarcomatoid or neuroendocrine type.

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I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any serious side effects.

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I am currently breastfeeding.

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I have previously been treated with or enrolled in a study for EV or PD1/PD-L1 inhibitors.

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I have received an organ or tissue transplant from another person.

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My bladder cancer is not the common type but one of the rare forms like sarcoma or melanoma.

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I have active cancer spread to my brain or spinal cord.

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

Overall response rate

Secondary study objectives

Duration of response

Incidence of adverse events

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (enfortumab vedotin, pembrolizumab)Experimental Treatment6 Interventions

Patients receive enfortumab vedotin IV and pembrolizumab IV on study. Patients also undergo CT scan or MRI, and collection of blood throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Computed Tomography

2017

Completed Phase 2

~2740