Health conditions
(Fonte di dati: WHO)
-C349 Bronchus or lung, unspecified
Bronchus or lung, unspecified;C349;Bronchus or lung, unspecified
Interventions (Fonte di dati: 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
(Fonte di dati: 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
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
5 apr 2016
Inserimento del primo partecipante
15 feb 2016
Stato di reclutamento
Complete
Titolo scientifico
(Fonte di dati: 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
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: 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
Fase
(Fonte di dati: WHO)
III
Contatto per informazioni
(Fonte di dati: WHO)
Bristol Myers Squibb Company
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
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)
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
Contatto per maggiori informazioni sulla sperimentazione
Contatto per informazioni generali
(Fonte di dati: WHO)
Marina
Ordonez
Av. Avenida Canaval Y Moreyra #380 6to piso
BRISTOL MYERS SQUIBB PERU S.A.
4116200
mordonez@bms.com
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Marina
Ordonez
Av. Avenida Canaval Y Moreyra #380 6to piso
BRISTOL MYERS SQUIBB PERU S.A.
4116200
mordonez@bms.com
Torna alla panoramica