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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Gilead Sciences
Study ID
NCT02864381
Phase
PHASE2
Status
Completed

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Andecaliximab — DRUG
    800 mg administered via IV infusion
  • Nivolumab — DRUG
    3 mg/kg administered via IV infusion

Study Details

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.

Key Dates

Start date
Sep 1, 2016
Status verified
Sep 2020
Primary completion
Nov 8, 2017
Completion
Aug 23, 2019

Study Design

Enrollment
144 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Andecaliximab + Nivolumab
    Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
  • Active Comparator: Nivolumab
    Nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 41 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia90095-
-San FranciscoCalifornia94158-
-ChicagoIllinois60637-
-Fort WayneIndiana46845-
-St LouisMissouri63110-
-New YorkNew York10065-

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