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
NCT02864381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2020-09-18
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
- DRUG
-
Andecaliximab
800 mg administered via IV infusion
- DRUG
-
3 mg/kg administered via IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-01
- Primary Completion
- 2017-11-08
- Completion
- 2019-08-23
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- France
- Hungary
- Italy
- Poland
- Spain
- United Kingdom
Study Locations
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