Phase II Study of Nivolumab and Relatlimab for Treating Melanoma That Has Spread to the Brain

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05704647

Provider View

This clinical trial is testing whether a combination of two drugs, nivolumab and relatlimab, can help control melanoma that has spread to the brain. The study will also look at the safety and side effects of this drug combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if using nivolumab together with relatlimab can effectively manage melanoma that has spread to the brain. Researchers will also study the safety and potential side effects of this treatment combination.

Description

This study aims to evaluate how well the combination of nivolumab and relatlimab works in treating melanoma that has spread to the brain. The main goals are to see how many patients experience a reduction in brain tumors and to assess the safety of the treatment. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates. Advanced imaging will be used to monitor changes in the brain, and the study will also explore how the treatment affects patients' quality of life and brain function. Additionally, the study will examine tumor samples and blood tests to understand the immune response and other biological changes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Expected to live for more than 12 weeks.
  • Must agree to participate and follow study procedures.
  • Have confirmed melanoma with brain metastases that can be measured.
  • Have at least one brain tumor that has not been treated with local therapy.
  • Provide a tumor sample for testing, if available.
  • Previous brain surgery or radiation is allowed if fully recovered.
  • No recent brain radiation within one week before starting the study.
  • No neurological symptoms from brain tumors and no recent steroid use.
  • Good overall health with a performance status of 0 or 1.
  • Adequate organ function based on specific tests.
  • Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control during and after treatment.
  • Any side effects from previous cancer treatments must be resolved.
  • Steroids for hormone replacement are allowed.

Exclusion Criteria

  • History of cancer spread to the brain's protective layers.
  • Recent brain radiation within one week before starting the study.
  • More than five brain lesions treated with radiation.
  • Brain tumors larger than 3 cm.
  • Previous treatment with certain immune therapies.
  • Active autoimmune diseases, except for certain stable conditions.
  • Major medical or psychiatric conditions that prevent full participation.
  • History of another cancer unless treated and cancer-free for two years.
  • Positive for hepatitis B or C, or HIV.
  • Recent use of corticosteroids or other immunosuppressive drugs.
  • Recent major surgery or significant injury.
  • Non-healing wounds or fractures.
  • Pregnant or breastfeeding women.
  • Uncontrolled illnesses or conditions that interfere with the study.
  • Significant heart disease or recent heart attack.
  • High levels of certain heart enzymes.
  • Recent use of investigational drugs.
  • History of lung inflammation requiring steroids.

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