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
Condition: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Andecaliximab; Nivolumab
Intervention description: 800 mg administered via IV infusion; 3 mg/kg administered via IV infusion
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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 Response Criteria in Solid Tumors (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 Cochran-Mantel Haenszel (CMH) test stratified by
             programmed death ligand 1 (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.