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
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
2 other identifiers
interventional
144
9 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2016
Typical duration for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2019
CompletedResults Posted
Study results publicly available
September 18, 2020
CompletedSeptember 18, 2020
September 1, 2020
1.2 years
August 10, 2016
August 18, 2020
September 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
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.
Up to 41 weeks
Secondary Outcomes (5)
Progression Free Survival (PFS)
Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
Overall Survival (OS)
Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months
Duration of Response (DOR)
Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
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
Study Arms (2)
Andecaliximab + Nivolumab
EXPERIMENTALAndecaliximab 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).
Nivolumab
ACTIVE COMPARATORNivolumab 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (34)
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Francisco, California, 94158, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Fort Wayne, Indiana, 46845, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Albury, New South Wales, 2640, Australia
Unknown Facility
Wahroonga, New South Wales, 2076, Australia
Unknown Facility
Douglas, Queensland, 4818, Australia
Unknown Facility
Hobart, Tasmania, 7000, Australia
Unknown Facility
La Louvière, Hainaut, 7100, Belgium
Unknown Facility
Ghent, Oost-Vlaanderen, 9000, Belgium
Unknown Facility
Leuven, Vlaams Brabant, 3000, Belgium
Unknown Facility
Brest, Finistère, 29609, France
Unknown Facility
Reims, Marne, 51092, France
Unknown Facility
Villejuif, Val-de-Marne, 94805, France
Unknown Facility
Budapest, H-1097, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Meldola, Forli-Cesena, 47014, Italy
Unknown Facility
Genova, Ligura, 16128, Italy
Unknown Facility
Milan, Lombardy, 20132, Italy
Unknown Facility
Pisa, Tuscany, 56126, Italy
Unknown Facility
Brzozów, Podkarpackie Voivodeship, 36-200, Poland
Unknown Facility
Poznan, 60-693, Poland
Unknown Facility
Warsaw, 02-781, Poland
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Majadahonda, Madrid, 28222, Spain
Unknown Facility
Barcelona, 08003, Spain
Unknown Facility
Bristol, BS2 8ED, United Kingdom
Unknown Facility
Edgbaston, B15 2PR, United Kingdom
Unknown Facility
London, EC1A 7BE, United Kingdom
Unknown Facility
London, WC1E 6BT, United Kingdom
Unknown Facility
Manchester, M20 4BX, United Kingdom
Unknown Facility
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 34893523DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 12, 2016
Study Start
September 1, 2016
Primary Completion
November 8, 2017
Study Completion
August 23, 2019
Last Updated
September 18, 2020
Results First Posted
September 18, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share