Enfortumab Vedotin + Pembrolizumab for Testicular and Urinary Tract Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Andrea B Apolo, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, enfortumab vedotin and pembrolizumab, in adults with rare testicle or urinary tract cancers. Enfortumab vedotin targets and kills cancer cells, while pembrolizumab boosts the immune system to fight the cancer. The goal is to see if this combination can help patients who have not responded to other treatments.

Eligibility Criteria

Adults with rare testicular or urinary tract cancers, including advanced adenocarcinoma and squamous cell carcinoma of the urinary tract, or refractory testicular germ cell tumors. Must have measurable disease and be in good physical condition (ECOG <=1). Some must have had prior anti-PD-1/PD-L1 therapy; others should not have received immune checkpoint inhibitors before. Women must agree to contraception use and discontinue breastfeeding.

Inclusion Criteria

Pre-study treatment tissue availability (sufficient tissue for 25 unstained slides) is mandatory for enrollment

My organs and bone marrow are functioning well.

Participants must be able to understand and willing to sign a written informed consent document

Exclusion Criteria

You have had serious allergic reactions to drugs similar to EV or pembrolizumab.

I have brain metastases that are causing symptoms or have not been treated.

Pregnant women as evaluated by a positive serum or urine beta-human chorionic gonadotropin (Beta-hCG) test at screening

Participant Groups

The trial is testing Enfortumab Vedotin (EV), alone or combined with Pembrolizumab, for treating certain rare genitourinary cancers. Participants will receive treatments through an IV at varying intervals over cycles lasting several weeks, potentially continuing up to five years, accompanied by regular scans and tests.

Group I: Arm 2 Experimental Treatment 2 Interventions

Treatment with enfortumab vedotin and pembrolizumab

Group II: Arm 1 Experimental Treatment 1 Intervention

Treatment with enfortumab vedotin

Enfortumab Vedotin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Padcev for:

• Locally advanced or metastatic urothelial cancer

🇪🇺 Approved in European Union as Padcev for:

• Locally advanced or metastatic urothelial cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References