Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and… (NCT05352672) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
United States1,546 participantsStarted 2022-07-14
Plain-language summary
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
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Age ≥12 years on the date of providing informed consent
✓. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease
Exclusion criteria
✕. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
✕. Measurable disease per RECIST v1.1
✕. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
✕. Cutaneous lesions should be evaluated as non-target lesions
✕. Performance status:
✕. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
✕. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)