Health conditions
(Fonte di dati: WHO)
Unresectable or Metastatic Melanoma
Interventions (Fonte di dati: WHO)
Biological: Nivolumab;Biological: Ipilimumab;Biological: Placebo for Nivolumab;Biological: Placebo for Ipilimumab
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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 na?ve 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
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
Progression Free Survival (PFS);Overall Survival (OS);Rate of Overall Survival;Rate of Progression-Free Survival
Punti finali secondari
(Fonte di dati: WHO)
Progression Free Survival (PFS);Overall Survival (OS);Objective Response Rate (ORR) Per Investigator Assessment;Progression-Free Survival Based on PD-L1 Expression Level;Overall Survival Based on PD-L1 Expression Level;Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status;Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning;Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning;Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning;Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning;Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Paesi di esecuzione
(Fonte di dati: WHO)
Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Czechia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contatto per maggiori informazioni sulla sperimentazione
Contatto per informazioni generali
(Fonte di dati: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Altri numeri di identificazione delle sperimentazioni
Secondary ID (Fonte di dati: WHO)
2012-005371-13
CA209-067
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