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.

View Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

144

Study ID:

NCT02864381

Recruitment Status:

Completed

Sponsor:

Gilead Sciences

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There are 34 Locations for this study

See Locations Near You


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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

144

Study ID:

NCT02864381

Recruitment Status:

Completed

Sponsor:


Gilead Sciences

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