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
NCT ID: NCT02864381
Last Updated: 2020-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2016-09-01
2019-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Andecaliximab
800 mg administered via IV infusion
Nivolumab
3 mg/kg administered via IV infusion
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).
Nivolumab
3 mg/kg administered via IV infusion
Interventions
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Andecaliximab
800 mg administered via IV infusion
Nivolumab
3 mg/kg administered via IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Los Angeles, California, United States
San Francisco, California, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
St Louis, Missouri, United States
New York, New York, United States
Albury, New South Wales, Australia
Wahroonga, New South Wales, Australia
Douglas, Queensland, Australia
Hobart, Tasmania, Australia
La Louvière, Hainaut, Belgium
Ghent, Oost-Vlaanderen, Belgium
Leuven, Vlaams Brabant, Belgium
Brest, Finistère, France
Reims, Marne, France
Villejuif, Val-de-Marne, France
Budapest, , Hungary
Debrecen, , Hungary
Meldola, Forli-Cesena, Italy
Genova, Ligura, Italy
Milan, Lombardy, Italy
Pisa, Tuscany, Italy
Brzozów, Podkarpackie Voivodeship, Poland
Poznan, , Poland
Warsaw, , Poland
Barcelona, Barcelona, Spain
Majadahonda, Madrid, Spain
Barcelona, , Spain
Bristol, , United Kingdom
Edgbaston, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Shah MA, Cunningham D, Metges JP, Van Cutsem E, Wainberg Z, Elboudwarej E, Lin KW, Turner S, Zavodovskaya M, Inzunza D, Liu J, Patterson SD, Zhou J, He J, Thai D, Bhargava P, Brachmann CB, Cantenacci DVT. Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival. J Immunother Cancer. 2021 Dec;9(12):e003580. doi: 10.1136/jitc-2021-003580.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Final
Document Type: Statistical Analysis Plan: Follow-up Analysis
Other Identifiers
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2016-001402-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-296-2013
Identifier Type: -
Identifier Source: org_study_id
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