Esophageal Cancer Clinical Trial
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
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 (immunotherapy-drugs-are-boosting-survival/" >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.
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There are 34 Locations for this study
Los Angeles California, 90095, United States
San Francisco California, 94158, United States
Chicago Illinois, 60637, United States
Fort Wayne Indiana, 46845, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Albury New South Wales, 2640, Australia
Wahroonga New South Wales, 2076, Australia
Douglas Queensland, 4818, Australia
Hobart Tasmania, 7000, Australia
La Louvière Hainaut, 7100, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Brest Finistère, 29609, France
Reims Marne, 51092, France
Villejuif Val-de-Marne, 94805, France
Budapest , H-109, Hungary
Debrecen , 4032, Hungary
Meldola Forli-Cesena, 47014, Italy
Genova Ligura, 16128, Italy
Milano Lombardia, 20132, Italy
Pisa Toscana, 56126, Italy
Brzozow Podkarpackie, 36-20, Poland
Poznań , 60-69, Poland
Warszawa , 02-78, Poland
Majadahonda Madrid, 28222, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Bristol , BS2 8, United Kingdom
Edgbaston , B15 2, United Kingdom
London , EC1A , United Kingdom
London , WC1E , United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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