Informations générales (source: ClinicalTrials.gov)
A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma
Interventional
Phase 3
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
janvier 2023
février 2030
14 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 06/06/2024 12:16:46 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Besancon Regional University Hospital Center - 25000 - Besancon - Doubs - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse (CFB) - 14076 - Caen - Normandy - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - 21000 - Dijon - Bourgogne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Valence - 26000 - Valence - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Le Mans - 72037 - Le Mans - Pays De La Loire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire De Nice Hopital De L Archet - 06202 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Grenoble Alpes - 38700 - La Tronche - Isere - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens-Picardie - 80000 - Amiens - Picardie - France | Contact (sur clinicalTrials) | ||||
| Chu De Bordeaux - 33075 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| CHU de Lille - 59000 - Lille - Hauts-de-France - France | Contact (sur clinicalTrials) | ||||
| CHU Estaing - 63003 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU-Dijon - 21000 - Dijon - Burgundy - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud, IUCT-Oncopole - 31059 - Toulouse - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
| N_Hôpital Ambroise-Paré - 92100 - Boulogne Billancourt - France | Contact (sur clinicalTrials) | ||||
| Nantes University Hospital - 44093 - Nantes - Pays De La Loire - France | Contact (sur clinicalTrials) | ||||
| Saint Louis Hospital - 75010 - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Sainte Catherine Institut du Cancer Avignon Provence - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Service de Dermatologie CHU Saint Eloi - 34295 - Montpellier Cedex 5 - Herault - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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