Study on Cryoablation with Pembrolizumab or Avelumab for Urothelial Carcinoma

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04701918

Provider View

This clinical trial is exploring the effectiveness of combining cryoablation with either pembrolizumab or avelumab to treat urothelial carcinoma, including bladder cancer, that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing a new treatment approach for urothelial carcinoma, including bladder cancer, that has spread. It combines cryoablation, a procedure that uses extreme cold to kill cancer cells, with either pembrolizumab or avelumab, which are drugs that help the immune system attack cancer. While these treatments are approved individually, their combination is still being studied. Participants will receive the treatment as long as it is effective and side effects are manageable, for up to two years. The study will include about 30 participants and is supported by Biocompatibles UK Ltd, which provides funding for the needles used in the cryoablation procedure.

Description

This clinical trial is designed to test the combination of cryoablation with either pembrolizumab or avelumab in treating urothelial carcinoma, including bladder cancer, that has spread. Cryoablation uses extreme cold to destroy cancer cells, potentially helping the immune system recognize and fight the cancer more effectively. Pembrolizumab and avelumab are drugs that enhance the immune system's ability to target cancer cells. The study will involve screening for eligibility, receiving the treatment, and attending follow-up visits. Participants will continue treatment as long as it is effective and side effects are tolerable, for up to two years. Approximately 30 people will participate in this study, which is supported by Biocompatibles UK Ltd, a company under Boston Scientific, providing funding for the cryoablation needles.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to understand and sign a consent form.
  • Must have medical insurance.
  • Must have a confirmed diagnosis of metastatic urothelial carcinoma, including bladder cancer, that has spread.
  • Must have at least one tumor larger than 2 cm that can be treated with cryoablation.
  • Must have a life expectancy of more than 12 weeks.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must meet specific blood test requirements, including:
    • Neutrophil count above 1 x 10^9/L
    • Platelet count above 75 x 10^9/L
    • Liver enzymes (ALT/AST) below 5 times the upper limit of normal
    • Total bilirubin below 3 mg/dL
    • INR below 1.7
    • Creatinine clearance above 30 ml/min

Exclusion Criteria

  • Tumors that have had prior radiation or other local treatments cannot be treated with cryoablation.
  • Cannot lie flat for the cryoablation procedure.
  • Have significant immune system deficiencies or certain autoimmune diseases.
  • Have ongoing side effects from previous cancer treatments, except for mild ones like hair loss.
  • Are taking high doses of steroids or other immune-suppressing medications.
  • Are on blood thinners that cannot be stopped before cryoablation.
  • Are pregnant or breastfeeding.
  • Have severe allergies to certain medications.
  • Have other medical conditions that could interfere with the study or increase risk.
  • Have had previous treatments with certain immune therapies.
  • Have had recent infections or other cancer treatments within a specified time before the study.

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