Health conditions
(Datenquelle: WHO)
Unresectable or Metastatic Melanoma
Interventions (Datenquelle: WHO)
Biological: Nivolumab;Biological: Ipilimumab;Biological: Placebo for Nivolumab;Biological: Placebo for Ipilimumab
Inclusion/Exclusion Criteria
(Datenquelle: 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
-
Weitere Informationen zur Studie
Rekrutierungsstatus
Active, not recruiting
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Datenquelle: WHO)
Phase 3
Primäre Endpunkte
(Datenquelle: WHO)
Progression Free Survival (PFS);Overall Survival (OS);Rate of Overall Survival;Rate of Progression-Free Survival
Sekundäre Endpunkte
(Datenquelle: 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
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: 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
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Weitere Studienidentifikationsnummern
Secondary ID (Datenquelle: WHO)
2012-005371-13
CA209-067
Zurück zur Übersicht