Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Interventional
Phase 3
Bristol-Myers Squibb (Voir sur ClinicalTrials)
mars 2023
novembre 2027
12 septembre 2025
The purpose of this study is to demonstrate that the study drug exposure level of the
nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab +
relatlimab FDC intravenous (IV) administration in participants with previously untreated
metastatic or unresectable melanoma.
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 | 25/05/2024 16:44:38 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Local Institution - 0007 - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0022 - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0034 - 75475 - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0046 - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0052 - 69310 - Pierre-Benite - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0061 - 94805 - Villejuif Cedex - Val-De-Marne - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0063 - 44093 - Nantes Cedex 01 - OH - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0089 - 35042 - Rennes Cedex - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0099 - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0108 - 31059 - Toulouse - Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0111 - 59000 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0117 - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0127 - 37044 - Chambray-les-Tours - Indre-Et-Loire - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0128 - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0129 - 63003 - Clermont Ferrand Cedex 1 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of
age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging
system.
- Participants must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and <
18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed
consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the AJCC staging system (8th edition).
Exclusion Criteria
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either
corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other
immunosuppressive medications within 14 days of start of study treatment. Inhaled or
topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone
equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of
age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging
system.
- Participants must have measurable disease by computed tomography (CT) or magnetic
resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and <
18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed
consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV
(metastatic) melanoma, per the AJCC staging system (8th edition).
Exclusion Criteria
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either
corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other
immunosuppressive medications within 14 days of start of study treatment. Inhaled or
topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone
equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.