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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Objective To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by overall survival (OS) Secondary Objectives To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by progression-free survival (PFS) To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) To compare the safety of GS-5745 versus placebo in combination with mFOLFOX6 Exploratory Objectives To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by duration of response (DOR), disease control rate (DCR), and time to response (TTR) To evaluate baseline levels and changes in blood-based biomarkers in subjects treated with GS-5745 or placebo in combination with mFOLFOX6 To evaluate baseline characteristics in tumor tissue and correlate with clinical outcome To compare the effect on patient reported quality of life (QoL) for GS-5745 versus placebo in combination with mFOLFOX6 as measured by EQ-5D-3L, QLQ-C30 and gastric cancer specific QLQ-STO22 questionnaire

Primary Objective To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by overall survival (OS) Secondary Objectives To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by progression-free survival (PFS) To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) To compare the safety of GS-5745 versus placebo in combination with mFOLFOX6 Exploratory Objectives To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by duration of response (DOR), disease control rate (DCR), and time to response (TTR) To evaluate baseline levels and changes in blood-based biomarkers in subjects treated with GS-5745 or placebo in combination with mFOLFOX6 To evaluate baseline characteristics in tumor tissue and correlate with clinical outcome To compare the effect on patient reported quality of life (QoL) for GS-5745 versus placebo in combination with mFOLFOX6 as measured by EQ-5D-3L, QLQ-C30 and gastric cancer specific QLQ-STO22 questionnaire