OncoMatch/Clinical Trials/NCT07818018
A Study of 2141-V11 in People With Esophageal, Gastric, or Gastroesophageal Junction Adenocarcinoma
Official title: A Phase 1b/II Study of Intratumoral CD40 Agonist 2141-V11 in Combination With Anti PD-1 and 5-Fluorouracil Therapy in Patients With Advanced Gastroesophageal Adenocarcinoma
Is NCT07818018 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including Intratumoral 2141-V11 and Nivolumab for esophageal cancer.
Treatment: Intratumoral 2141-V11 · Nivolumab · Fluoropyrimidine — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Esophageal Carcinoma
Gastric Cancer
Biomarker criteria
Excluded: MLH1 loss
Mismatch repair deficient (dMMR) disease by IHC
Excluded: MSH2 loss
Mismatch repair deficient (dMMR) disease by IHC
Excluded: MSH6 loss
Mismatch repair deficient (dMMR) disease by IHC
Excluded: PMS2 loss
Mismatch repair deficient (dMMR) disease by IHC
Excluded: MSI high
microsatellite instability (MSI-H) by next-generation sequencing
Excluded: HER2 (ERBB2) overexpression
Known HER2-positive disease (IHC 3+ or IHC 2+ and amplification via fluorescence in situ hybridization)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy (fluoropyrimidine + anti-PD-1) (5-fluorouracil, nivolumab) — first line for advanced GEA
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.
Cannot have received: radiation therapy to primary esophageal, gastric, or gastroesophageal junction tumor
Prior radiation therapy to primary esophageal, gastric, or gastroesophageal junction tumor
Cannot have received: PD-1, PD-L1, or CTLA-4 inhibitor before ongoing regimen
Prior treatment before ongoing regimen for any reason with PD-1, PD-L1, or CTLA-4 inhibitors
Lab requirements
Blood counts
absolute neutrophil count ≥1000/mcl; platelets ≥90,000/mcl; hemoglobin ≥8 g/dl
Kidney function
serum creatinine ≤1.5x uln
Liver function
serum total bilirubin ≤1.5x uln or direct bilirubin ≤uln for participants with total bilirubin levels >1.5x uln, except patients with gilbert's disease (≤3x uln); ast and alt ≤3x uln; albumin ≥3 mg/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited protocol activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07818018 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiation therapy to primary esophageal, gastric, or gastroesophageal junction tumor, PD-1, PD-L1, or CTLA-4 inhibitor before ongoing regimen disqualifies patients from enrollment.
Are patients with MLH1 alterations eligible?
No. MLH1 loss is an exclusion criterion.
Are patients with MSH2 alterations eligible?
No. MSH2 loss is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages