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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Drug: Nivolumab; Drug: Andecaliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02864381

2016-001402-41 (EudraCT Number)

GS-US-296-2013

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Andecaliximab + Nivolumab

Experimental group

Description:

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).

Treatment:

Drug: Andecaliximab

Drug: Nivolumab

Nivolumab

Active Comparator group

Description:

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).

Treatment:

Drug: Nivolumab