Study on the Safety and Effectiveness of Fianlimab and Cemiplimab Compared to Pembrolizumab in Treating Resectable Stage 3 or 4 Melanoma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT06190951

This clinical trial is testing whether a combination of two drugs, fianlimab and cemiplimab, is safe and works better than the standard treatment, pembrolizumab, for adults with stage 3 or 4 melanoma that can be surgically removed.

Patient Parameters

Program Overview

The study is exploring a new treatment for melanoma, a type of skin cancer, using two drugs called fianlimab and cemiplimab. These drugs are being compared to pembrolizumab, a medication already approved for use. The goal is to see if the combination of fianlimab and cemiplimab is more effective in treating high-risk melanoma that can be surgically removed. Researchers are also looking at potential side effects, how the drugs are processed in the body, whether the body develops antibodies against the drugs, and how the treatment might improve quality of life.

Eligibility Criteria

Inclusion Criteria

  • Have stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) melanoma that can be completely removed by surgery.
  • Have melanoma that is confirmed as cancerous by a pathology report.
  • Be eligible for surgery with the goal of curing the cancer, and be able to have all cancer removed with clear margins.
  • Undergo full disease staging with a physical exam and imaging tests, including CT scans and MRI, within 4 weeks before starting the study.
  • Have an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have primary uveal melanoma.
  • Have an autoimmune disease that required treatment with immunosuppressive drugs in the past 2 years, except for certain conditions like vitiligo or childhood asthma that has resolved.
  • Have received any prior systemic anti-cancer therapy for melanoma, except for certain cases of prior radiotherapy.
  • Have uncontrolled infections like HIV, hepatitis B, or hepatitis C, or an immunodeficiency that leads to chronic infection.
  • Have used high doses of corticosteroids within 14 days before starting the study.
  • Have been treated for other cancers in the past 5 years, except for certain cases.
  • Have a history of myocarditis.
  • Have a significant infection requiring antibiotics within 2 weeks before starting the study.

Locations

FACILITYZIPCITYSTATE
USC Norris Comprehensive Cancer Center90033Los AngelesCalifornia
California Pacific Medical Center Research Institute94115San FranciscoCalifornia
UCSF94143San FranciscoCalifornia
St John's Cancer Institute90404Santa MonicaCalifornia
Hartford Hospital06102HartfordConnecticut
Emory University30322AtlantaGeorgia
University of Massachusetts Chan Medical School01655WorcesterMassachusetts
Washington University School of Medicine63110Saint LouisMissouri
Rutgers Cancer Institute of New Jersey08901New BrunswickNew Jersey
Seidman Cancer Center44106ClevelandOhio

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