Study on Pre-Surgery Combination Immunotherapy for Stage III Melanoma

Sponsor: University of Louisville

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03842943

Provider View

This clinical trial is testing a combination of two immunotherapy drugs, Talimogene Laherparepvec (T-VEC) and Pembrolizumab, given before surgery to remove lymph nodes in patients with stage III melanoma that can be surgically treated.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of using two immunotherapy drugs, T-VEC and Pembrolizumab, before surgery in patients with stage III melanoma. These drugs are given for six months before the surgical removal of affected lymph nodes to see if they can help control the cancer.

Description

This study involves treating patients with stage III melanoma using a combination of two immunotherapy drugs, T-VEC and Pembrolizumab, before they undergo surgery to remove lymph nodes. The treatment lasts for six months and aims to determine if this approach is safe and effective in managing the cancer. The study is designed for patients whose melanoma can be surgically removed and who have visible lymph node involvement.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, of any race or gender, with a confirmed diagnosis of skin melanoma.
  • Must be in good general health, able to perform daily activities with minimal restrictions.
  • Must have good blood, liver, kidney, and blood clotting function.
  • Must have measurable cancer and a lymph node that can be injected with the treatment.
  • The primary melanoma tumor must have been removed.
  • Must have stage III melanoma that can be surgically removed, as determined by a melanoma specialist.
  • The stage III melanoma can be newly diagnosed or a recurrence after earlier treatment of stage I-II melanoma.
  • Can have either BRAF mutant or wild type melanoma.
  • Must provide signed, written consent to participate in the study.

Exclusion Criteria

  • Cannot have cancer that has spread beyond the lymph nodes (metastatic disease).
  • Cannot have melanoma that started in mucosal areas or the eye.
  • Cannot have melanoma linked to immune system problems or other cancers (except non-melanoma skin cancer) in the past three years.
  • Cannot have been previously treated with T-VEC, any other similar virus treatments, Pembrolizumab, or similar drugs.
  • Cannot have a history of certain autoimmune diseases or conditions requiring treatment in the past two years, except for vitiligo or resolved childhood asthma/allergies.
  • Cannot have active herpes skin infections or need regular treatment for herpes, except for occasional topical treatments.

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