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Brief Title: MK-3475 as Maintenance Therapy in Extensive Stage SCLC
Official Title: Phase II Study of MK-3475 as Maintenance Therapy in Extensive Stage Small Cell Lung Cancer (SCLC) Patients
Study ID: NCT02359019
Brief Summary: This phase II trial studies how well pembrolizumab works in treating patients with extensive stage small cell lung cancer after completion of combination chemotherapy. Pembrolizumab may be effective in controlling small cell lung cancer for a longer period of time in patients with responsive or stable disease after completion of combination chemotherapy.
Detailed Description: PRIMARY OBJECTIVES: I. To assess Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined progression-free survival (PFS) in extensive stage small cell lung cancer (SCLC) patients, who have complete response (CR), partial response (PR) or stable disease following minimum of 4 cycles of platinum (cisplatin or carboplatin) and etoposide. SECONDARY OBJECTIVES: I. To assess modified PFS in all patients enrolled. II. To assess overall survival of patients enrolled on the trial. III. To assess programmed cell death 1 ligand 1 (PD-L1) expression in archival tumor tissues and in circulating tumor cells (CTCs) and correlate the expression to RECIST defined PFS. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Rush University Medical Center, Chicago, Illinois, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Cleveland Clinic, Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Name: Ammar Sukari
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: PRINCIPAL_INVESTIGATOR