None listed
Conditions
Interventions
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
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Countries
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
Contacts
Public ContactMarina Ordonez
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed