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

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.

Timeline

Start

2016-09-01

Primary completion

2017-11-08

Completion

2019-08-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Andecaliximab + Nivolumab vs Nivolumab; p = 0.8; NCT02864381 ↗

paper There was no response or survival benefit associated with adding ADX. PMID 34893523 ↗

Publications

• Shah MA, Cunningham D, Metges JP, Van Cutsem E, Wainberg Z, Elboudwarej E, Lin KW, Turner S, Zavodovskaya M, Inzunza D, Liu J, Patterson SD, Zhou J, He J, Thai D, Bhargava P, Brachmann CB, Cantenacci DVT. Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival. J Immunother Cancer. 2021 Dec;9(12):e003580. doi: 10.1136/jitc-2021-003580.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andecaliximab	Monoclonal antibody	800 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous

Indications