Active, Not Recruiting
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067) - CA209-067
Mis à jour: 5 janvier, 2024 | ClinicalTrials.gov
Phase
Sexe(s)
Tranche d’âge
Active, Not Recruiting
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically confirmed stage III (unresectable) or stage IV melanoma - Treatment naïve patients - Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria - Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Ocular melanoma - Subjects with active, known or suspected autoimmune disease - Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment - Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
Nous vous recommandons fortement de contacter BMS pour signaler les effets secondaires (événements indésirables).
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici.
Signaler des effets secondaires (effets indésirables) ou des plaintes concernant la qualité du produit: Informations médicales
