The purpose of this study is to find out whether adding the drug 2141-V11 to standard treatment (anti-PD-1 immunotherapy with or without 5-FU) is a safe treatment approach for participants with advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma
Histologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
Locally advanced unresectable or metastaticdisease at diagnosis
On first line systemic therapy including fluoropyrimidine + anti-PD-1 therapy for advanced GEA (e.g. FOLFOX + nivolumab) for a minimum of 3 months and no more than 9 months.
Platinum chemotherapy included in first line regimen has been discontinued or will be discontinued ≥2 weeks prior to first planned dose of 2141-V11
Mismatch repair deficient (dMMR) disease by IHC or microsatellite instability (MSI-H) by next-generation sequencing
Known HER2-positive disease (IHC 3+ or IHC 2+ and amplification via fluorescence in situ hybridization)
Prior radiation therapy to primary esophageal, gastric, or gastroesophageal junction tumor
Anti-PD-1 therapy in ongoing regimen has been discontinued for any reason
Sequential
Intratumoral 2141-V11
Biological/Vaccine2141-V11 is a recombinant fully humanized IgG1 monoclonal antibody directed against CD40, which activates the CD40 receptor.
Nivolumab
Biological/VaccineNivolumab will be given as an intravenous infusion.
Fluoropyrimidine
Drug5-FU will be administered as a continuous infusion over 48 hours
Evaluate safety of intratumoral 2141-V11
The primary endpoint of the safety lead-in cohort is safety. Safety is defined as the incidence of dose-limiting toxicities (DLTs) during the 6-week DLT evaluation window.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Rockefeller University
Collaborator
