Last updated 32 days ago
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
1530 patients around the world
Available in Spain, United States, Chile, Argentina
Regeneron Pharmaceuticals
7Research sites
1530Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- All patients must be either stage 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 protocolComplete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgeryAll 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
- Uveal melanomaAny evidence of residual disease after surgery by imaging, pathology, or cytology.Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agentsUncontrolled 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 protocolAnother malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocolParticipants with a history of myocarditis.Adolescent patients (≥12 to <18 years old) with body weight <40 kg
Sites
DIABAID – Instituto de asistencia integral en diabetes y patologías crónicas, CABA, Buenos Aires
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Centro Médico San Roque S.R.L. - Tucumán
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Oncocentro APYS - Valparaíso
Recruiting
SponsorRegeneron Pharmaceuticals
Conditions
Melanoma
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05608291
