Study on Fianlimab and Cemiplimab Compared to Pembrolizumab for Treating Advanced Melanoma in Adolescents and Adults

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05352672

Provider View

This clinical trial is testing a new combination of drugs, fianlimab and cemiplimab, to see if they are effective in treating advanced melanoma, a type of skin cancer, compared to the standard treatment with pembrolizumab. The study includes both adolescents and adults who have not received prior treatment for their advanced melanoma.

Patient Parameters

Program Overview

This study is exploring a new treatment for melanoma, a serious type of skin cancer, using two drugs called fianlimab and cemiplimab. Researchers want to see if this combination works better than the current standard treatment, pembrolizumab, in patients who have not been treated before. The study will also look at how the drugs affect adolescents compared to adults, what side effects might occur, how the drugs are processed in the body, and if the body creates antibodies against them, which could affect their effectiveness or cause side effects.

Eligibility Criteria

Inclusion Criteria

  • Be 12 years or older.
  • Have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery.
  • Have not received any previous treatment for advanced melanoma.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health, with a performance status score indicating full activity or some restriction in strenuous activities.
  • Have a life expectancy of at least 3 months.

Exclusion Criteria

  • Have a type of melanoma called uveal melanoma.
  • Have an autoimmune disease that required treatment with immunosuppressive drugs in the past 2 years, except for certain conditions like vitiligo or resolved childhood asthma.
  • Have uncontrolled infections like HIV, hepatitis B, or hepatitis C.
  • Have unknown BRAF V600 mutation status.
  • Be using immunosuppressive drugs or have other forms of immune suppression.
  • Have received other cancer treatments within 21 days before starting the study.
  • Have significant infections requiring antibiotics within 14 days before starting the study.
  • Have untreated or active brain metastases or spinal cord compression, unless specific conditions are met.

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