Study on Enfortumab Vedotin and Radiation for Localized Muscle Invasive Bladder Cancer in Patients Who Cannot Use Cisplatin

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06394570

Provider View

This clinical trial is testing a combination of the drug enfortumab vedotin and radiation therapy before surgery to see if it can help treat muscle invasive bladder cancer in patients who cannot use the standard chemotherapy drug cisplatin.

Patient Parameters

Program Overview

The STAR-EV study is exploring whether combining enfortumab vedotin with radiation therapy before surgery can help treat muscle invasive bladder cancer. This approach is being tested in patients who cannot use cisplatin, a common chemotherapy drug. The study will try different schedules for giving the drug and radiation to find the safest and most effective way to use them together. After this treatment, all patients will have surgery to remove the bladder as part of their regular care.

Description

The STAR-EV study is a clinical trial designed to test the safety and effectiveness of combining enfortumab vedotin with radiation therapy before surgery in patients with muscle invasive bladder cancer. This study is for patients who cannot receive cisplatin-based chemotherapy and are scheduled for bladder removal surgery.

All participants will receive the same treatment:

  • Enfortumab vedotin (PADCEV) will be given through an IV on Days 1 and 8 of a 21-day cycle, for a total of 3 cycles.
  • Radiation therapy will be directed at the bladder, either after or during the enfortumab vedotin treatment.
  • Surgery will involve removing the bladder and nearby lymph nodes, with urinary diversion as needed.

The study will start with a safety phase to ensure the treatment is safe, using a method to gradually increase the dose of radiation. The main goals are to find the safest dose and to see how well the treatment works in eliminating cancer before surgery. Participants will be monitored for one year after surgery or after completing the pre-surgery treatment if they do not have surgery.

Eligibility Criteria

Inclusion Criteria

  • Have bladder cancer that is mainly urothelial type and is planned for bladder removal surgery.
  • Cannot use cisplatin-based chemotherapy due to specific health reasons like kidney issues, nerve damage, hearing loss, or heart problems, or by choice.
  • Be 18 years or older.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1500/mm3.
    • Platelet count of at least 100,000/mm3.
    • Hemoglobin level of at least 9 g/dL.
    • Liver enzymes and bilirubin levels within specified limits.
    • No end-stage kidney disease requiring dialysis.
  • Agree to use effective birth control during the study and for three months after treatment.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have received prior systemic therapy for bladder cancer, except for certain treatments over a year ago or specific bladder treatments.
  • Have significant nerve damage (Grade 2 or higher).
  • Be taking other experimental cancer treatments.
  • Have allergies to enfortumab vedotin or similar drugs.
  • Have uncontrolled health issues like infections, heart problems, or mental health conditions that could interfere with the study.
  • Be pregnant or breastfeeding due to potential risks to the baby.

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