Study on Enfortumab Vedotin and Pembrolizumab for Bladder Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05239624

Provider View

This clinical trial is testing whether a combination of two drugs, enfortumab vedotin and pembrolizumab, can effectively treat bladder cancer that has spread to the lymph nodes in patients scheduled for surgery. The study aims to see if these drugs can shrink or eliminate cancer in the lymph nodes before surgery.

Patient Parameters

Program Overview

The purpose of this study is to find out if using enfortumab vedotin and pembrolizumab together can help treat bladder cancer that has spread to the lymph nodes. Researchers want to see if this combination can reduce or remove cancer in the lymph nodes before patients undergo surgery to remove their bladder cancer. Both drugs are designed to help the immune system attack cancer cells, and the study will explore if they work better together than alone.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of muscle invasive bladder cancer.
  • Cancer must be at a specific stage, either T2-T4, N1-N3, M0 or cT1, N2-N3, M0.
  • Must have tumor samples available for testing.
  • Cancer must be suitable for surgery if treatment is successful.
  • Patients can participate whether or not they are eligible for platinum-based chemotherapy.
  • No previous treatments for muscle invasive or metastatic bladder cancer.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must have adequate kidney function.
  • Must be willing to provide informed consent and follow study requirements.
  • Must agree to use effective contraception during and after the study treatment period.

Exclusion Criteria

  • Severe heart disease or recent heart-related events.
  • Ongoing heart rhythm problems, unless controlled.
  • Severe nerve damage.
  • Major surgery within 28 days before starting the study, except for bladder surgery.
  • Mental health or substance abuse issues that would interfere with the study.
  • Positive pregnancy test for women of childbearing potential.
  • Participation in another treatment trial.
  • Previous treatment with certain immune therapies.
  • Recent cancer treatments or live vaccines.
  • Active infections or immune system disorders.
  • Uncontrolled diabetes or autoimmune diseases.
  • Severe lung disease or active hepatitis.
  • Recent severe infections or antibiotic use.
  • Previous organ transplants or unresolved side effects from past cancer treatments.
  • Other serious health conditions that could affect study participation.

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