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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

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+ nivolumab for up to 2 years
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

Experimental: Nivolumab
Nivolumab for up to 2 years
Drug: Nivolumab
3 mg/kg administered via intravenous (IV) infusion every 2 weeks




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 2 years ]
    Objective response rate will be determined from the participants' best response during treatment.


Secondary Outcome Measures :
  1. 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.

  2. Overall Survival [ Time Frame: Up to 5 years ]
    Overall survival is defined as the interval from date of randomization to death from any cause.

  3. 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.

  4. 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.



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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 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.


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


  Show 34 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02864381     History of Changes
Other Study ID Numbers: GS-US-296-2013
2016-001402-41 ( EudraCT Number )
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: September 2019
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
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs