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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

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ClinicalTrials.gov Identifier: NCT02864381
Recruitment Status : Completed
First Posted : August 12, 2016
Results First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Drug: Andecaliximab Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: 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).
Drug: Andecaliximab
800 mg administered via IV infusion
Other Name: GS-5745

Drug: Nivolumab
3 mg/kg administered via IV infusion

Active Comparator: 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).
Drug: Nivolumab
3 mg/kg administered via IV infusion




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 41 weeks ]
    ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months ]
    PFS was defined as the interval in months from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause. The first definitive progressive disease (PD) was defined as the first radiation therapy, the first clinical PD, and the first confirmed imaging PD, whichever came first. Participants without PD or death and participants with PD after starting new anti-cancer therapy are censored at the last tumor assessment date.

  2. Overall Survival (OS) [ Time Frame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months ]
    OS was defined as the interval from the date of randomization to death from any cause. Surviving participants are censored at the last date known alive.

  3. Duration of Response (DOR) [ Time Frame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months ]
    DOR was defined as the interval from the date of the first response (complete or partial response) was achieved to the earlier of the first documentation of definitive disease progression or death from any cause.

  4. Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participants administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events that are defined as AEs with onset dates on or after the first dose of andecaliximab/nivolumab and up to 30 days after permanent discontinuation of andecaliximab or 5 months after permanent discontinuation of nivolumab, or led to premature discontinuation of andecaliximab or nivolumab.

  5. Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities [ Time Frame: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months ]
    Treatment-emergent (Chemistry, Hematology, Coagulation, and Urinalysis) laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of andecaliximab plus 30 days or nivolumab plus 5 months. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment-emergent. Percentage of participants with any postbaseline Grade 1 or higher laboratory abnormality is reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864381


Locations
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United States, California
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94158
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Fort Wayne, Indiana, United States, 46845
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10065
Australia, New South Wales
Albury, New South Wales, Australia, 2640
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Douglas, Queensland, Australia, 4818
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Belgium
La Louvière, Hainaut, Belgium, 7100
Gent, Oost-Vlaanderen, Belgium, 9000
Leuven, Vlaams Brabant, Belgium, 3000
France
Brest, Finistère, France, 29609
Reims, Marne, France, 51092
Villejuif, Val-de-Marne, France, 94805
Hungary
Budapest, Hungary, H-1097
Debrecen, Hungary, 4032
Italy
Meldola, Forli-Cesena, Italy, 47014
Genova, Ligura, Italy, 16128
Milano, Lombardia, Italy, 20132
Pisa, Toscana, Italy, 56126
Poland
Brzozow, Podkarpackie, Poland, 36-200
Poznań, Poland, 60-693
Warszawa, Poland, 02-781
Spain
Majadahonda, Madrid, Spain, 28222
Barcelona, Spain, 08003
Barcelona, Spain, 08035
United Kingdom
Bristol, United Kingdom, BS2 8ED
Edgbaston, United Kingdom, B15 2PR
London, United Kingdom, EC1A 7BE
London, United Kingdom, WC1E 6BT
Manchester, United Kingdom, M20 4BX
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] June 16, 2017
Statistical Analysis Plan: Final  [PDF] December 6, 2017

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02864381    
Other Study ID Numbers: GS-US-296-2013
2016-001402-41 ( EudraCT Number )
First Posted: August 12, 2016    Key Record Dates
Results First Posted: September 18, 2020
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents