Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

  • Interventional
  • Recruiting
  • NCT02864381
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or GEJ which have progressed on at least 1 prior systemic therapy or line of treatment for unresectable/metastatic disease

         - Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1

         - Measurable disease according to RECIST v1.1

         - Tumor sites that can be accessed for repeat biopsies

         - Archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a PD-L1 stratification test, as assessed by central pathologist

         - Individuals not receiving anticoagulant medication must have an international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin (aPTT) ≤ 1.5 x upper limit of normal (ULN)

         - Required baseline laboratory data as outlined in protocol

        Key Exclusion Criteria:

         - Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma

         - Radiotherapy within 28 days of randomization

         - Uncontrolled intercurrent illness as outlined in protocol

         - History of a concurrent or second malignancy except for those outlined in protocol

         - Major surgery, within 28 days of first dose of study drug

         - Known positive status for human immunodeficiency virus (HIV)

         - Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

         - Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

         - Known or suspected central nervous system metastases

         - Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization

         - Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics

         - Current or history of pneumonitis or interstitial lung disease

         - Active known or suspected autoimmune disease with exceptions noted in protocol.

         - History of bone marrow, stem cell, or allogenic organ transplantation

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

At a Glance

National Government IDNCT02864381

IRB#IRB16-1166

Lead SponsorGilead Sciences

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting