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Antibody-drug conjugate

Enfortumab Vedotin + Pembrolizumab for Bladder Cancer

Phase 2

Recruiting

Led By Jean Hoffman-Censits, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Patients must refuse definitive radical nephroureterectomy (RNU), or be medically ineligible for surgery

Subjects must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma

Must not have

Subjects with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer

Subjects with ongoing sensory or motor neuropathy Grade 2 or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a combo of drugs for patients with UTUC who don't want surgery. It will see if the drugs can give outcomes similar to surgery.

Who is the study for?

This trial is for adults with high grade upper tract urothelial cancer who haven't had systemic therapy for advanced cancer, are opting out of or can't have surgery, and don’t have metastatic disease. Participants must be in good health otherwise, able to consent, and meet specific conditions if they can have children.

What is being tested?

The study tests combining pembrolizumab and enfortumab vedotin as a treatment option instead of standard surgery. It aims to see if this drug combo can lead to survival rates similar to those achieved by the usual surgical procedure without spreading the cancer.

What are the potential side effects?

Potential side effects include reactions at the injection site, fatigue, rash, loss of appetite, changes in taste sensation, hair loss from chemotherapy drugs like enfortumab vedotin; immune-related effects such as inflammation in organs may occur with pembrolizumab.

Eligibility Criteria

Inclusion Criteria

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

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I cannot or choose not to have major surgery to remove my kidney and ureter.

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I have not had any treatment for advanced bladder cancer.

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I am 18 or older with a confirmed diagnosis of high-grade upper tract urothelial cancer.

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My cancer has not spread to other parts of my body or lymph nodes.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have another cancer besides non-melanoma skin cancer or prostate cancer that is not actively growing.

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

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I am on high doses of steroids or other drugs that weaken my immune system.

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I have active tuberculosis.

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I have previously received enfortumab vedotin or similar drugs.

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I have been treated with a PD-(L)-1 inhibitor for cancer.

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My diabetes is not under control.

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I have an active eye infection or corneal ulcer.

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I have been treated for an autoimmune disease in the last 2 years.

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I am experiencing severe side effects from previous cancer treatments.

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I am currently on medication for an infection.

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I have an active hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Event free survival (EFS)

Secondary study objectives

Glomerular Filtration Rate (GFR)

Other study objectives

Overall Survival

Progression free survival

To assess feasibility of obtaining immune biomarker data from UTUC biopsy specimens

+2 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: Enfortumab vedotin with PembrolizumabExperimental Treatment2 Interventions

The study population will include male and female patients over the age of 18 with high grade UTUC (cN0/xM0) and is ineligible for or refuses definitive radical nephroureterectomy (RNU). Enfortumab vedotin will be administered on Days 1 and 8 at 1.25mg/kg of every 3-week cycle by intravenous (IV) infusion given over approximately 30 minutes. Pembrolizumab will be administered on Day 1 at 200mg of every 3-week cycle by IV infusion over approximately 30 minutes. Enfortumab vedotin and Pembrolizumab may be administered for up to total of 35 cycles (approximately 2 years).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enfortumab vedotin

2017

Completed Phase 2

~240

Pembrolizumab

2017

Completed Phase 3

~3130