Health conditions
(Datenquelle: WHO)
-C349 Bronchus or lung, unspecified
Bronchus or lung, unspecified;C349;Bronchus or lung, unspecified
Interventions (Datenquelle: WHO)
Arm A: Nivolumab (Solution for Injection 10mg/mL) 240 mg administered every 2 weeks as a 30 minute Intra-venous infusion.
Arm B: Nivolumab (Solution for Injection 10mg/mL) 1 mg/kg (30 minute Intra-venous infusion) and ipilimumab (Solution for Injection 5mg/mL) 3 mg/kg (90 minute Intra-venous infusion) every 3 weeks for four doses, followed by nivolumab 240 mg every 2 weeks.
Arm C: Placebo for Nivolumab/Ipilimumab (0.9% sodium chloride injection or 5% dextrose injection).
Inclusion/Exclusion Criteria
(Datenquelle: WHO)
Gender: --
Maximum age: 99
Minimum age: 18
Inclusion criteria:
1)Subjects with SCLC documented by histology or cytology.
2)Initial diagnosis with extensive stage disease (Stage IV).
3) ECOG Performance Status 0 or 1.
4)Subjects must have received 4 cycles of platinum-based first line chemotherapy and must have an ongoing response of complete response (CR), partial response (PR), or stable disease (SD) after completion of chemotherapy.
5) Randomized ≤ 7 weeks from the last dose of platinum-based first line chemotherapy.
6) A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation.
Exclusion criteria:
1.Subjects with untreated central nervous system metastases are excluded
2.Subjects with active, known, or suspected autoimmune disease are excluded
3.All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
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Weitere Informationen zur Studie
Datum der Studienregistrierung
05.04.2016
Einschluss der ersten teilnehmenden Person
15.02.2016
Rekrutierungsstatus
Complete
Wissenschaftlicher Titel
(Datenquelle: WHO)
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 3 STUDY OF NIVOLUMAB, NIVOLUMAB IN COMBINATION WITH IPILIMUMAB, OR PLACEBO AS MAINTENANCE THERAPY IN SUBJECTS WITH EXTENSIVE-STAGE DISEASE SMALL CELL LUNG CANCER (ED-SCLC) AFTER COMPLETION OF PLATINUM-BASED FIRST LINE CHEMOTHERAPY
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
This is a randomized, double-blind, three-arm, multicenter, Phase 3 study in adult subjects with ED-SCLC, who achieve Stable Disease, Partial Response or Complete Response after completion of platinum based first line chemotherapy. Approximately 810 subjects will be randomized in a 1:1:1 ratio to treatment with either nivolumab monotherapy (Arm A), nivolumab/ipilimumab combination therapy (Arm B), or placebo (Arm C) and will be stratified according to the following factors.
- ECOG Performance Status: 0 vs 1
- Gender: Male vs Female
- Prophylactic Cranial Irradiation (PCI) following chemotherapy
Phase
(Datenquelle: WHO)
III
Kontakt für Auskünfte
(Datenquelle: WHO)
Bristol Myers Squibb Company
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea South, Mexico, Poland, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Marina
Ordonez
Av. Avenida Canaval Y Moreyra #380 6to piso
BRISTOL MYERS SQUIBB PERU S.A.
4116200
mordonez@bms.com
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Marina
Ordonez
Av. Avenida Canaval Y Moreyra #380 6to piso
BRISTOL MYERS SQUIBB PERU S.A.
4116200
mordonez@bms.com
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