Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Conditions

• Melanoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fianlimab — DRUG
  Intravenous (IV) infusion
• Cemiplimab — DRUG
  IV infusion
• Pembrolizumab — DRUG
  IV infusion
• Placebo — DRUG
  IV infusion

Study Details

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life

Key Dates

Start date

Jul 14, 2022

Status verified

Apr 2026

Primary completion

Mar 12, 2026

Completion

Sep 16, 2031

Study Design

Enrollment

1,546 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A: fianlimab+cemiplimab dose 1
  As defined in Protocol Amendment 5
• Experimental: A1: fianlimab+cemiplimab dose 2
  As defined in Protocol Amendment 5
• Experimental: B: pembrolizumab+placebo
  As defined in Protocol Amendment 5
• Experimental: C: cemiplimab+placebo
  As defined in Protocol Amendment 5

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Approximately 27 months ]

Locations (5)

Related coverage on Hipa.ai

• Fianlimab Combination Melanoma Trial Reaches Primary Completion
  Fianlimab · Mar 12, 2026 · ClinicalTrials.gov

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