Clinical trial NCT02864381: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 41 weeks
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
measure: Overall Survival (OS)
timeFrame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months
measure: Duration of Response (DOR)
timeFrame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
measure: Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
timeFrame: 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
measure: Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Albury
country: Australia
state: New South Wales
city: Wahroonga
country: Australia
state: New South Wales
city: Douglas
country: Australia
state: Queensland
city: Hobart
country: Australia
state: Tasmania
city: La Louvière
country: Belgium
state: Hainaut
city: Gent
country: Belgium
state: Oost-Vlaanderen
city: Leuven
country: Belgium
state: Vlaams Brabant
city: Brest
country: France
state: Finistère
city: Reims
country: France
state: Marne
city: Villejuif
country: France
state: Val-de-Marne
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Meldola
country: Italy
state: Forli-Cesena
city: Genova
country: Italy
state: Ligura
city: Milano
country: Italy
state: Lombardia
city: Pisa
country: Italy
state: Toscana
city: Brzozow
country: Poland
state: Podkarpackie
city: Poznań
country: Poland
city: Warszawa
country: Poland
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Bristol
country: United Kingdom
city: Edgbaston
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.