Study on Using Pembrolizumab and Enfortumab Vedotin for High Grade Upper Tract Urothelial Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT05656235

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and enfortumab vedotin, for patients with high grade upper tract urothelial cancer who choose not to have surgery. The study aims to see if this treatment can provide similar outcomes to surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if a combination of pembrolizumab and enfortumab vedotin can effectively treat high grade upper tract urothelial cancer (UTUC) in patients who prefer not to undergo the standard surgery, known as radical nephroureterectomy (RNU). The trial will assess if this drug combination can achieve similar survival outcomes as surgery in patients without cancer spread to other parts of the body.

Description

This study involves using two drugs, enfortumab vedotin and pembrolizumab, to treat patients with high grade upper tract urothelial cancer who are unable or unwilling to have the usual surgery to remove the kidney and ureter. The treatment will be given through an IV every 21 days to 20 patients until the cancer progresses or the patient cannot tolerate the treatment.

The main goal is to see how long patients can live without the cancer spreading or worsening, compared to historical data from patients who had surgery. The study will focus on patients with non-metastatic cancer, meaning it has not spread beyond the kidney and ureter area.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of high grade upper tract urothelial cancer.
  • Patients who refuse or are not eligible for surgery due to high risk of complications.
  • No prior systemic therapy for advanced urothelial cancer, except in specific cases where previous chemotherapy was given over 12 months ago.
  • May have small lymph node involvement but no other cancer spread.
  • Must provide a tumor sample for eligibility.
  • Good overall health with specific blood and organ function levels.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test.
  • Men must use effective birth control and not donate sperm during and after the study.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Previous treatment with enfortumab vedotin or similar drugs.
  • Prior treatment with PD-1 or PD-L1 inhibitors.
  • Uncontrolled diabetes or other serious health conditions.
  • Life expectancy less than 12 weeks.
  • Active infections or other cancers that could interfere with the study.
  • Recent major surgery or radiation therapy.
  • Severe allergies to study drugs or their components.
  • History of autoimmune diseases requiring treatment in the past two years.
  • Previous organ transplants or live vaccines within 30 days before starting the study.
  • Active tuberculosis or other conditions that could impair participation.

Locations

FACILITYZIPCITYSTATE
Johns Hopkins University: Sibley Memorial Hospital20016WashingtonDistrict of Columbia
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center21287BaltimoreMaryland

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