Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional trial combining intratumoral 2141-V11 with systemic treatments, including nivolumab and fluoropyrimidine-based chemotherapy. It includes phase 1 and phase 2 to assess safety and preliminary efficacy in patients whose disease is locally advanced unresectable or metastatic and who are on first-line systemic therapy. Eligibility requires measurable disease, endoscopy-confirmed tumor presence, adequate organ function, and good performance status. The study is led by Memorial Sloan Kettering Cancer Center with collaboration from Rockefeller University and is conducted at several MSK locations in New Jersey. Primary endpoints are focused on safety and tolerability, with secondary aims to observe anti-tumor activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
  * Patients in the safety lead-in cohort must be on 5-FU
* Primary esophageal, gastric, or gastroesophageal junction tumor intact and visible at time of enrollment (within 1 month of 2141-V11 treatment initiation) on endoscopy
* Evaluable disease at time of 2141-V11 treatment initiation as defined per RECIST v1.1
* Able to undergo endoscopy
* Age 18 years or older
* ECOG performance status 0 to 1 (See Appendix I for performance status criteria)
* Adequate organ function as defined by:

  * Absolute neutrophil count ≥1000/mcL
  * Platelets ≥90,000/mcL
  * Hemoglobin ≥8 g/dL
  * Serum creatinine ≤1.5X ULN
  * 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 Abbreviations: ALT, alanine aminotransferase; AST, aminotransferase; ULN, upper limit of normal.

Exclusion Criteria:

* 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
* Disease progression on frontline therapy
* Patients with active autoimmune disease requiring ongoing systemic steroids or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment.
* Ongoing systemic steroids or receipt of systemic steroid therapy exceeding prednisone 10 mg/day or equivalent within 7 days before first dose, except physiologic replacement or short-course premedication (e.g. as antiemetics or CT scan contrast premedication), or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
* Patients with active infection on parenteral antibiotics
* Patients with history of grade 3 or higher immune related adverse events to anti-PD-1 therapy may only be enrolled with the permission of the study PI.
* Prior treatment before ongoing regimen for any reason with PD-1, PD-L1, or CTLA-4 inhibitors
* Currently participating in a therapeutic study and receiving study therapy or has participated in a therapeutic study within 4 weeks of the first dose of treatment. Radiographic protocols including protocols with experimental tracers are not considered therapeutic studies and are exempt.
* Known active central nervous system metastases and/or leptomeningeal disease
* HIV, HBV, and HCV testing do not need to be performed as part of the study. For patients with known HIV, HBV, and/or HCV infection:

  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited protocol activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Samuel Cytryn, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Samuel Cytryn, MD
• Email: CytrynS@mskcc.org
• Phone: 646-888-4896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.