Phase 2
N=144
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
Gastric Adenocarcinoma · Gastroesophageal Junction Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02864381 ↗Enrolled (actual)
144
Serious AEs
56.7%
Results posted
Sep 2020
Primary outcome: Primary: Objective Response Rate (ORR) — 9.7; 6.9 percentage of participants — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Andecaliximab (Drug); Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
9.7; 6.9 | 0.8 |
| SECONDARY Progression Free Survival (PFS) |
1.840; 1.856 | 0.306 |
| SECONDARY Overall Survival (OS) |
7.162; 5.881 | 0.312 |
| SECONDARY Duration of Response (DOR) |
NA; NA | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) |
98.6; 97.1 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities |
20.0; 27.1; 45.1; 40.0; 30.0; 28.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02864381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.