A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Plain-language summary

This study examines whether the combination of Fianlimab and Cemiplimab works better than Pembrolizumab at preventing or delaying the return of melanoma (a skin cancer) that has been completely removed by surgery. Patients with stage IIB, IIC, III or IV melanoma (per AJCC 8th edition) whose tumor was completely surgically removed may take part. The study is in Phase 3 and is currently active but not recruiting new participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Active, not recruiting

Sponsor

Regeneron Pharmaceuticals

Intervention

Fianlimab, Cemiplimab, Pembrolizumab, Placebo

Start date

1/16/2023

Estimated completion

2/15/2030

Countries

United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Mexico, Poland, Romania, South Africa, Spain, Turkey (Türkiye), United Kingdom

Related genes

Locations

• La Jolla, United States
• San Francisco, United States
• Santa Monica, United States
• Englewood, United States
• Miami, United States
• Orlando, United States
• Tampa, United States
• Chicago, United States
• Boston, United States
• Boston, United States
• Detroit, United States
• New Brunswick, United States
• New York, United States
• New York, United States
• Rochester, United States
• Chapel Hill, United States
• Durham, United States
• Cleveland, United States
• Cleveland, United States
• Columbus, United States
• Easton, United States
• Pittsburgh, United States
• Knoxville, United States
• Nashville, United States
• Nashville, United States
• Dallas, United States
• Murray, United States
• Charlottesville, United States
• Caba, Argentina
• Pergamino, Argentina
• Viedma, Argentina
• Rosario, Argentina
• San Miguel de Tucumán, Argentina
• Caba, Argentina
• Blacktown, Australia
• Lismore, Australia
• Liverpool, Australia
• Wollstonecraft, Australia
• Bedford Park, Australia
• North Adelaide, Australia

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Key Inclusion Criteria:

1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
3. All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Key Exclusion Criteria:

1. Uveal melanoma
2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.
3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
6. Participants with a history of myocarditis
7. Adolescent patients (≥12 to \<18 years old) with body weight \<40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply