MK-3475 as Maintenance Therapy in Extensive Stage SCLC

Inclusion Criteria

• Patients with extensive stage SCLC who have completed at least 4 cycles of platinum (carboplatin/cisplatin) and etoposide chemotherapy as their first line therapy and have responding or stable disease to this therapy are eligible for this study; patients who received platinum/etoposide previously for SCLC and it was repeated for recurrence will not be eligible
• Patients should be willing and able to provide written informed consent for the trial
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Demonstrate adequate organ function, all screening laboratories (labs) should be performed within 14 days of treatment initiation
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 9 g/dL or >= 5.6 mmol/L
• Serum creatinine = = 45 mL/min for subject with creatinine levels > 1.5 X institutional ULN; glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance [CrCl])
• Creatinine clearance should be calculated per institutional standard
• Serum total bilirubin = 1.5 ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = 1 year
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

Exclusion Criteria

• Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy greater than 10 mg/day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
• Has had prior chemotherapy, targeted small molecule therapy, or definitive radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent; patients who received palliative radiation to any site or prophylactic cranial radiation (=< 30 Gray [Gy]) or thoracic RT can start therapy with the study drug 7 days after the last day of radiation therapy as long as they have recovered from any adverse effects (i.e., =< grade 1 or at baseline) of such radiation therapy
• Note: subjects with =< grade 2 neuropathy or adverse events that are not considered clinically meaningful such as alopecia are an exception to this criterion and may qualify for the study
• Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
• Has a known additional malignancy that is progressing or requires active treatment; patient will be eligible if other malignancy is controlled and the treating physician determines that the patient's outcome is unlikely to be affected by the other tumor
• Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are clinically stable and any neurologic symptoms have returned to baseline, have no clinical evidence of new or enlarging brain metastases, and are not using steroids greater than prednisone 10mg/day or equivalent dose of another steroid" prior to start of trial treatment
• Has an active autoimmune disease, including a paraneoplastic syndrome of autoimmune nature, requiring systemic treatment other than chemotherapy for SCLC, within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires or required systemic steroids or immunosuppre