Health conditions
(Source de données: WHO)
Unresectable or Metastatic Melanoma
Interventions (Source de données: WHO)
Biological: Nivolumab;Biological: Ipilimumab;Biological: Placebo for Nivolumab;Biological: Placebo for Ipilimumab
Inclusion/Exclusion Criteria
(Source de données: 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
-
Plus d’informations sur l’étude
Statut de recrutement
Active, not recruiting
Titre scientifique
(Source de données: 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
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Source de données: WHO)
Phase 3
Points finaux primaires
(Source de données: WHO)
Progression Free Survival (PFS);Overall Survival (OS);Rate of Overall Survival;Rate of Progression-Free Survival
Points finaux secondaires
(Source de données: 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
Contact pour informations
(Source de données: WHO)
Please refer to primary and secondary sponsors
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Pays où sont réalisées les études
(Source de données: 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
Contact pour plus d’informations sur l’étude
Contact pour des informations générales
(Source de données: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contact pour des informations scientifiques
(Source de données: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Plus de numéros d’identification d’étude
Secondary ID (Source de données: WHO)
2012-005371-13
CA209-067
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