Last updated 2 months ago
Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
1535 patients around the world
Available in Mexico, Argentina, Chile, United States, Spain
Regeneron Pharmaceuticals
21Research sites
1535Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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.Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies.Patients must have had a treatment-free and disease-free interval of >6 months.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).Anticipated life expectancy of at least 3 months.
- Uveal melanoma.Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents.The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.Unknown BRAF V600 mutation status as described in the protocol.Systemic immune suppression: Use of immunosuppressive doses of corticosteroids (>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication.Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent.Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.Other clinically relevant forms of systemic immune suppression.Treatment with other anti-cancer therapy including immuno-therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment.Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.Active or untreated brain metastases or spinal cord compression.Patients with leptomeningeal disease are excluded.Patients with known brain metastases are eligible if they received radiotherapy or another appropriate standard therapy for the brain metastases.Patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment.Patients did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment.Patients are asymptomatic with a single untreated brain metastasis <10 mm in size.Participants with a history of myocarditis.
Sites
DIABAID – Instituto de asistencia integral en diabetes y patologías crónicas, CABA, Buenos Aires
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Centro Médico San Roque S.R.L. - Tucumán
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
FAICIC Clinical Research
Recruiting
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V. - Jalisco
Recruiting
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde - Guadalajara
Recruiting
SponsorRegeneron Pharmaceuticals
Study typeInterventional
Conditions
Melanoma
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05352672
