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Active (not recruiting) Phase 3 NCT05625399

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

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

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 17
Australia (1)
Local Institution - 0050
Coffs Harbour , New South Wales
Belgium (1)
Local Institution - 0072
Brussels
Brazil (1)
Local Institution - 0177
Fortaleza , Ceará
Canada (1)
Local Institution - 0141
Calgary , Alberta
Chile (1)
Local Institution - 0143
Temuco , Araucania
Czech Republic (1)
Local Institution - 0083
Prague , NY
Finland (1)
Local Institution - 0164
Helsinki
France (1)
Local Institution - 0108
Toulouse , Cedex 9
Germany (1)
Local Institution - 0101
Heidelberg , Baden-Wurttemberg
Israel (1)
Local Institution - 0026
Afula
Italy (1)
Local Institution - 0051
Bari
Norway (1)
Local Institution - 0163
Bodø
Poland (1)
Local Institution - 0171
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Spain (1)
Local Institution - 0012
Donostia / San Sebastian , Gipuzkoa
Sweden (1)
Local Institution - 0062
Solna , Stockholm County
United Kingdom (1)
Local Institution - 0088
London , Greater London
United States (1)
Local Institution - 0125
Phoenix , Arizona
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
06.03.2023
Completion date
18.11.2027
Registry ID
NCT05625399
Source
anzctr
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