NCT02864381

Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Andecaliximab	800 mg administered via IV infusion
DRUG	Nivolumab	3 mg/kg administered via IV infusion

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-11-08
• Completion: 2019-08-23
• First posted: 2016-08-12
• Last updated: 2020-09-18
• Results posted: 2020-09-18

Locations

34 sites across 9 countries: United States, Australia, Belgium, France, Hungary, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study