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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
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE September 1, 2016
Actual Primary Completion Date November 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
Objective Response Rate [ Time Frame: Up to 2 years ]
Objective response rate will be determined from the participants' best response during treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02864381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • Progression Free Survival [ Time Frame: Up to 2 years ]
    Progression free survival is defined as the interval from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause.
  • Overall Survival [ Time Frame: Up to 5 years ]
    Overall survival is defined as the interval from date of randomization to death from any cause.
  • Duration of Response [ Time Frame: Up to 2 years ]
    Duration of response is defined as the interval from the date of the first response (complete response or partial response) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause.
  • Occurrence of Adverse Events and Laboratory Abnormalities During Treatment [ Time Frame: Up to 2 years ]
    The occurrence of adverse events and laboratory abnormalities will be presented as the percentage of participants who experience treatment-emergent adverse events or treatment-emergent laboratory abnormalities.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • Drug: Andecaliximab
    800 mg administered via intravenous (IV) infusion every 2 weeks
    Other Name: GS-5745
  • Drug: Nivolumab
    3 mg/kg administered via intravenous (IV) infusion every 2 weeks
Study Arms  ICMJE
  • Experimental: Andecaliximab+nivolumab
    Andecaliximab+ nivolumab for up to 2 years
    Interventions:
    • Drug: Andecaliximab
    • Drug: Nivolumab
  • Experimental: Nivolumab
    Nivolumab for up to 2 years
    Intervention: Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2017)
144
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
120
Actual Study Completion Date  ICMJE August 23, 2019
Actual Primary Completion Date November 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   France,   Hungary,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT02864381
Other Study ID Numbers  ICMJE GS-US-296-2013
2016-001402-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP