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Active (not recruiting) Phase 3 NCT05608291

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

Phase 3 – large-scale trial before approval
Conditions: Melanoma

Sponsor: Regeneron Pharmaceuticals

trial.available_in: БГ
Overview
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. 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 drug (which could make the drug 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
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
Locations 22
Argentina (1)
Fundacion Centro de Investigaciones para la Transformacion (CENIT)
Caba , Buenos Aires
Australia (1)
Blacktown Cancer and Haematology Centre - Blacktown Hospital
Blacktown , New South Wales
Belgium (1)
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas , Oost-Vlaanderen
Brazil (1)
Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte , Minas Gerais
Canada (1)
Dr. Everett Chalmers Hospital
Fredericton , New Brunswick
Chile (1)
Clinica UC San Carlos de Apoquindo
Santiago , Santiago Metropolitan
Czech Republic (1)
Masaryk Memorial Cancer Institute
Brno , Brno Mesto
France (1)
Centre Georges Francois Leclerc
Dijon , Bourgogne-Franche-Comté
Georgia (1)
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi , Caucasus
Germany (1)
University Medical Center Mannheim
Mannheim , Baden-Wurttemberg
Greece (1)
National and Kapodistrian University of Athens
Athens , Attica
Ireland (1)
Galway University Hospital
Galway , Connacht
Israel (1)
Haemek Medical Center
Afula , Northern District
Italy (1)
Clinica Oncologica, AOU Riuniti Ancona
Ancona , An
Mexico (1)
Preparaciones Oncologica SC
León , Guanajuato
Poland (1)
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce , Mazxowieckie
Romania (1)
Institute of Oncology Bucharest
Bucharest , Bucharest
South Africa (1)
The Medical Oncology Centre of Rosebank
Johannesburg , Gauteng
Spain (1)
H. Germans Trias i Pujol, ICO-Badalona
Badalona , Barcelona
Turkey (1)
Baskent University
Yüreğir , Adana
United Kingdom (1)
Royal Devon and Exeter Hospital NHS Trust
Exeter , Devon
United States (1)
UC San Diego
La Jolla , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
16.01.2023
Completion date
15.02.2030
Registry ID
NCT05608291
Source
anzctr
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