Study on Whether Fianlimab and Cemiplimab Work Better Than Pembrolizumab to Prevent Melanoma from Returning After Surgery

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05608291

Provider View

This clinical trial is testing if a combination of two drugs, fianlimab and cemiplimab, is more effective than the drug pembrolizumab in preventing melanoma from coming back after it has been surgically removed. The study also examines potential side effects, drug levels in the blood, and the body's response to the drugs.

Patient Parameters

Program Overview

The purpose of this study is to find out if using two drugs, fianlimab and cemiplimab, together can better prevent melanoma from returning after surgery compared to using pembrolizumab alone. Pembrolizumab is already approved for use in some countries for this purpose. The study will also look at what side effects might occur, how much of the drugs are in the blood at different times, whether the body creates antibodies against the drugs, and if the treatment improves quality of life.

Eligibility Criteria

Inclusion Criteria

  • Patients must have stage IIB, IIC, III, or IV melanoma that has been completely removed by surgery.
  • Surgery must have been done within 12 weeks before joining the study, and the surgical wound must be healed.
  • Patients must be free of disease, confirmed by a physical exam and imaging tests within 4 weeks before joining the study.

Exclusion Criteria

  • Patients with uveal melanoma.
  • Any remaining disease after surgery, as shown by imaging or lab tests.
  • Significant autoimmune disease needing treatment in the last 2 years.
  • Uncontrolled infections like HIV, hepatitis B, or hepatitis C, or any immune system deficiency causing chronic infection.
  • Another cancer that is currently active or needed treatment in the last 5 years.
  • History of myocarditis.
  • Adolescents aged 12 to under 18 years who weigh less than 40 kg.

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