Javelin- Gastric 100

The primary objective of this trial is to demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Overall Survival (OS) in subjects who have not progressed on first-line chemotherapy Secondary objectives:  To demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Progression-free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).  To demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to objective response rate (ORR) as per RECIST v1.1.  To compare the subject-reported outcomes / quality of life of subjects when treated with avelumab versus continuation of first-line chemotherapy as assessed by the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ-5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ-STO22  To determine the safety and tolerability of avelumab Exploratory objectives  To evaluate tumor shrinkage in target lesions at each time point from baseline  To evaluate PD-L1 expression levels in tumor cells and cells of the tumor microenvironment (for example, infiltrating lymphocytes) as candidate predictive biomarker with their relation to selected clinical response parameters  To determine duration of response  To determine time to response  To characterize population pharmacokinetics (PK) of avelumab and individual drug exposures based on sparse PK sampling  To characterize exposure response (exposure safety and exposure efficacy) for avelumab with respect to selected safety and efficacy endpoints  To explore molecular, cellular, and soluble markers (for example, but not limited to changes in gene expression profiles, microsatellite instability status, tumor-infiltrating lymphocytes and cytokine levels) in peripheral blood and/or tumor tissue that may be relevant to the mechanism of action of, or response/resistance to avelumab  To characterize the immunogenicity of avelumab.

January 13, 2017