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A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Subjects With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
Primary Objective:
To evaluate and compare the efficacy of andecaliximab in combination with nivolumab
versus nivolumab alone in subjects with recurrent gastric or GEJ adenocarcinoma
Secondary Objectives:
To characterize and compare safety and tolerability of andecaliximab in combination with
nivolumab versus nivolumab alone in subjects with recurrent gastric or GEJ adenocarcinoma
To characterize the pharmacokinetics (PK) of andecaliximab in combination with nivolumab
Exploratory Objectives:
To evaluate baseline tumor microenvironment characteristics and whether they correlate with
clinical outcome
To explore immunomodulatory activities of andecaliximab in combination with nivolumab
versus nivolumab alone
To investigate whether PD-L1 expression (by IHC) correlates with clinical outcome
To investigate whether tumor genomic instability associates with clinical outcome
To investigate whether subtype: intestinal (well-differentiated) vs. diffuse (undifferentiated)
correlates with clinical outcome
Primary Objective:
To evaluate and compare the efficacy of andecaliximab in combination with nivolumab
versus nivolumab alone in subjects with recurrent gastric or GEJ adenocarcinoma
Secondary Objectives:
To characterize and compare safety and tolerability of andecaliximab in combination with
nivolumab versus nivolumab alone in subjects with recurrent gastric or GEJ adenocarcinoma
To characterize the pharmacokinetics (PK) of andecaliximab in combination with nivolumab
Exploratory Objectives:
To evaluate baseline tumor microenvironment characteristics and whether they correlate with
clinical outcome
To explore immunomodulatory activities of andecaliximab in combination with nivolumab
versus nivolumab alone
To investigate whether PD-L1 expression (by IHC) correlates with clinical outcome
To investigate whether tumor genomic instability associates with clinical outcome
To investigate whether subtype: intestinal (well-differentiated) vs. diffuse (undifferentiated)
correlates with clinical outcome
Recruitment Status
Past Studies