Study on Adjusting Enfortumab Vedotin Treatment Schedule for Advanced Urothelial Cancer

Sponsor: Fox Chase Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05923190

Provider View

This clinical trial is exploring a new schedule for administering Enfortumab Vedotin, alone or with pembrolizumab, to treat adults with advanced urothelial cancer. The study aims to find out if changing the treatment schedule can be effective and safe.

Patient Parameters

Program Overview

This study is testing a new way to give Enfortumab Vedotin, a cancer treatment, to adults with advanced urothelial cancer. Researchers want to see if changing how often the drug is given, either by itself or with another drug called pembrolizumab, can help treat the cancer effectively. The study will include about 50 patients receiving Enfortumab Vedotin alone and 20 patients receiving it with pembrolizumab. All participants must have confirmed advanced urothelial cancer and meet certain health criteria.

Description

This clinical trial is designed to test a new schedule for giving Enfortumab Vedotin to adults with advanced urothelial cancer. The study has two parts: one where patients receive Enfortumab Vedotin alone, and another where they receive it with pembrolizumab. About 50 patients will be in the first group, and 20 in the second. Participants must have confirmed advanced urothelial cancer and meet specific health requirements, such as being in good general health and having normal organ function. The study will help determine if the new schedule is safe and effective.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed advanced urothelial cancer.
  • Must have at least one tumor that can be measured.
  • Planned to receive Enfortumab Vedotin, alone or with pembrolizumab, as standard treatment.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have completed any previous cancer treatments at least 14 days before starting the study.
  • Must be 18 years or older.
  • Must be able to understand and sign a consent form.
  • Must provide a tumor sample if available.
  • Must have normal organ and bone marrow function, including:
    • Neutrophil count above 1,000/mm3
    • Platelet count above 100,000/ul
    • Hemoglobin above 8.0 g/dL
    • Liver enzymes (ALT and AST) within specified limits
    • Kidney function (creatinine clearance) above 20 ml/min

Exclusion Criteria

  • Have received certain previous treatments for urothelial cancer.
  • Have significant nerve damage or uncontrolled diabetes.
  • Have untreated or uncontrolled brain cancer spread.
  • Have serious ongoing illnesses or infections.
  • Have had another cancer within the last 3 years that needs treatment.
  • Are currently receiving treatment for an active infection.
  • Are HIV-positive and on certain medications.
  • Have certain lung diseases or have had a transplant.
  • Have active tuberculosis.
  • Are pregnant or breastfeeding.
  • For the pembrolizumab group only:
    • Have had previous immunotherapy with serious side effects.
    • Have active autoimmune diseases needing treatment in the past 2 years.
    • Are on high-dose steroids.

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