Last updated 17 days ago
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
570 patients around the world
Available in Argentina, Chile, Brazil
Bristol-Myers Squibb
19Research sites
570Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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).
- 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.
Sites
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Instituto Americas - COI
Recruiting
Oncocentro Serviços Médicos e Hospitalares Ltda
Recruiting
Hospital Santa Rita
Recruiting
Personal Oncologia de Precisao e Personalizada
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
UPCO Unidade de Pesquisa Clinica em Oncologia
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
StudyRELATIVITY-127
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Melanoma
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05625399
