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.
Clinical Trial Information
Trial Contact: Larney, Patricia; Jobson, Gillian S
Age Group: Adult
Phase: Drug: Phase III
Principal Investigator: Omar R. Kayaleh, MD
Secondary Protocol No:
Applicable Disease Sites: stomach/ GE Junction