Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18 - 75
Clinical summary
Summary
The primary objective of this study is to evaluate and compare the efficacy of GS-5745 in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Conditions
This trial is treating people with Gastric and Gastro-Oesophageal Cancer
Eligibility
Inclusion
- 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
Exclusion
- 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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Gilead Sciences, Inc.
Scientific 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
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