Study on Cryoablation Combined with Ipilimumab and Nivolumab for Treating Melanoma

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05779423

Provider View

This clinical trial is exploring whether combining two approved immunotherapy drugs, ipilimumab and nivolumab, with a procedure called cryoablation can safely and effectively treat melanoma that cannot be surgically removed and has not responded to previous immunotherapy treatments.

Patient Parameters

Program Overview

The purpose of this study is to determine if using two immunotherapy drugs, ipilimumab and nivolumab, along with cryoablation (a procedure that freezes part of a tumor), can help treat melanoma that has not responded to other treatments. The study will assess the safety and effectiveness of this combination in patients with melanoma that cannot be surgically removed and has continued to grow despite previous treatment with PD-1 inhibitors.

Description

This study is a Phase II clinical trial designed to test the safety and effectiveness of combining ipilimumab and nivolumab with cryoablation for treating metastatic melanoma that is resistant to PD-1 inhibitors. Ipilimumab and nivolumab are immunotherapy drugs that help the immune system attack cancer cells. Cryoablation is a procedure that freezes and removes tumors. While ipilimumab and nivolumab are approved for treating melanoma, their combination with cryoablation is experimental.

Participants will undergo various procedures, including eligibility screening, in-clinic visits, blood tests, CT scans, and tumor biopsies. The study is expected to last up to 3 years, with about 37 participants involved. The William M. Wood Foundation is funding the research activities, including cryoablation.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with melanoma that cannot be surgically removed and has progressed after treatment with immune checkpoint inhibitors like pembrolizumab or nivolumab.
  • Patients must be eligible for treatment with ipilimumab and nivolumab, as determined by their doctor.
  • Must have a tumor that can be treated with cryoablation.
  • Must have measurable disease, meaning at least one tumor that can be accurately measured.
  • Previous radiation therapy is allowed, except at the site planned for cryoablation.
  • Must have a performance status score of 2 or less, indicating they are able to carry out light work.
  • Life expectancy of more than 3 months.
  • Adequate organ and bone marrow function, as shown by specific blood test results.
  • HIV-positive participants on effective treatment with undetectable viral load are eligible.
  • Participants with controlled hepatitis B or cured hepatitis C are eligible.
  • Participants with asymptomatic brain metastases are eligible.
  • Participants with other cancers that do not interfere with the study treatment are eligible.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Tumors planned for cryoablation must not have had prior radiation or other local treatments.
  • Inability to stop blood thinners if required for cryoablation.
  • Currently receiving other investigational treatments.
  • Progressing on ipilimumab/nivolumab as the last treatment.
  • Not recovered from side effects of previous cancer treatments.
  • Have symptomatic brain metastases.
  • Taking more than 10mg of oral prednisone or equivalent.
  • Have uncontrolled illnesses.
  • Pregnant or breastfeeding women are excluded due to potential risks to the baby.

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