Study on Pembrolizumab and Targeted Radiation Therapy for Treating Mucosal Melanoma

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04318717

Provider View

This clinical trial is testing a combination of pembrolizumab, an immunotherapy drug, and targeted radiation therapy to see if it can better control mucosal melanoma, a type of skin cancer, compared to radiation therapy alone.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of combining pembrolizumab, an immunotherapy drug, with targeted radiation therapy in patients with mucosal melanoma. Researchers aim to see if this combination can improve local tumor control compared to historical data from patients who received only radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of mucosal melanoma that has been surgically removed.
  • Must not have received radiation therapy in the area of interest before.
  • Be at least 16 years old.
  • Be in relatively good health, with a performance status score of 2 or less, meaning able to carry out light work or more.
  • Have normal blood and organ function, including:
    • Neutrophil count of at least 1,200/mcL.
    • Platelet count of at least 100,000/mcL.
    • Total bilirubin level within 1.5 times the normal limit.
    • Liver enzymes (AST/ALT) within 3 times the normal limit.
    • Kidney function with creatinine clearance over 30 mL/min.
  • Agree to use effective birth control during the study and for 6 months after the last dose of pembrolizumab, as its effects on an unborn baby are unknown.
  • Be able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have had another type of cancer, unless treatment was completed over 2 years ago and there is no evidence of disease.
  • Have received radiation therapy in the area of interest.
  • Are currently taking other experimental drugs.
  • Have cancer that has spread to other parts of the body.
  • Have a history of severe allergic reactions to pembrolizumab or similar drugs.
  • Have uncontrolled health issues like ongoing infections, heart failure, or unstable heart conditions.
  • Have an immune deficiency or are taking immune-suppressing drugs, except for low-dose prednisone (up to 10 mg/day).
  • Have an active autoimmune disease needing treatment in the past 2 years, except for replacement therapies like insulin or thyroid hormone.
  • Have a history of lung disease requiring steroids or current lung disease.
  • Have received a live vaccine within 30 days before starting treatment.
  • Are pregnant or breastfeeding. Women must have a negative pregnancy test before starting the study.
  • Have HIV with low CD4+ T-cell counts or recent serious infections, unless on effective antiretroviral therapy.

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