Study on Neoadjuvant Immunotherapy with Tavo and Electroporation Combined with Nivolumab for Melanoma Patients

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04526730

Provider View

This clinical trial is exploring a new treatment approach for patients with advanced melanoma that can be surgically removed. The study combines an immunotherapy drug, Tavo, delivered directly into the tumor with electroporation, and another drug, Nivolumab, given through an IV infusion.

Patient Parameters

Program Overview

This Phase 2 study is testing a new treatment for patients with advanced melanoma that can be surgically removed. The treatment involves injecting a drug called Tavo directly into the tumor using a technique called electroporation, which helps the drug enter the cancer cells. Patients will also receive Nivolumab, an immunotherapy drug, through an IV infusion. The goal is to see if this combination can help control the cancer before surgery.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of melanoma.
  • Cancer must be operable and fit into one of the following categories:
    1. Primary melanoma with regional lymph node spread.
    2. Recurrence of melanoma in regional lymph nodes.
    3. Primary melanoma affecting multiple regional lymph nodes.
    4. Single site of nodal metastatic melanoma from an unknown primary source.
    5. In transit or satellite metastases that can be surgically removed.
    6. Distant metastases that can be surgically removed and biopsied.
  • Eligible at initial diagnosis or at recurrence.
  • Must undergo full body imaging and brain scans as part of initial evaluation.
  • Have at least one tumor that can be measured and treated with electroporation.
  • Must use effective contraception if of childbearing potential.
  • Must be able to give informed consent and comply with study requirements.

Exclusion Criteria

  • Have another progressing cancer needing treatment, except for certain skin cancers or cervical cancer.
  • Have HIV, active Hepatitis B or C, or other serious infections.
  • Have a condition affecting the immune system or are on immunosuppressive therapy.
  • Have a history of lung disease or current lung issues.
  • Have an active infection needing treatment.
  • Have any condition that could interfere with the study.
  • Have not recovered from side effects of previous treatments.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have electronic pacemakers or defibrillators.
  • Have had a live-virus vaccine recently.
  • Have had recent blood transfusions or growth factor treatments.
  • Have previously received certain immunotherapies.
  • Are participating in another clinical study or have had recent systemic therapy.
  • Have a performance status greater than 1.
  • Have inadequate organ function.
  • Have severe allergies to Nivolumab or its ingredients.

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