Title: 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 Adenocarcinoma1
Description: For this phase 2, randomized, 2-armed trial (ClinicalTrials.gov Identifier: NCT02864381), researchers are evaluating the efficacy and safety of andecaliximab (GS-5745) and nivolumab vs nivolumab alone among patients with unresectable or recurrent gastroesophageal junction or gastric cancer.
Patients must have inoperable, locally advanced or metastatic disease that progressed after at least 1 prior therapy.
The study has 2 arms: in the first, patients will receive andecaliximab 800 mg intravenously every 2 weeks plus intravenous nivolumab 3 mg/kg every 2 weeks; in the second, patients will receive intravenous nivolumab 3 mg/kg every 2 weeks.
The primary outcome is overall response rate; secondary outcomes include progression-free survival, overall survival, duration of response, and frequency/variety of adverse events.
For more study information, including detailed inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02864381.
Status: This study is open and recruiting participants as of April 7, 2017.
This study is sponsored by Gilead Sciences. Andecaliximab is a humanized monoclonal antibody that targets matrix metalloproteinase 9 (MMP-9).
- Clinicaltrials.gov. Andecaliximab combined with nivolumab versus nivolumab alone in adults with unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma. NCT02864381. https://clinicaltrials.gov/ct2/show/NCT02864381. Accessed April 7, 2017.