Health conditions
(Data source: WHO)
-C349 Bronchus or lung, unspecified
Bronchus or lung, unspecified;C349;Bronchus or lung, unspecified
Interventions (Data source: 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
(Data source: 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
-
Further information on trial
Date trial registered
Apr 5, 2016
Incorporation of the first participant
Feb 15, 2016
Recruitment status
Complete
Academic title
(Data source: 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
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: 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
(Data source: WHO)
III
Contact information
(Data source: WHO)
Bristol Myers Squibb Company
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: 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
Contact for further information on the trial
Contact for general information
(Data source: WHO)
Marina
Ordonez
Av. Avenida Canaval Y Moreyra #380 6to piso
BRISTOL MYERS SQUIBB PERU S.A.
4116200
mordonez@bms.com
Contact for scientific information
(Data source: WHO)
Marina
Ordonez
Av. Avenida Canaval Y Moreyra #380 6to piso
BRISTOL MYERS SQUIBB PERU S.A.
4116200
mordonez@bms.com
Back to overview
