2141-V11 for Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Samuel Cytryn, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced esophageal, stomach, or gastroesophageal junction adenocarcinoma. Participants should have these cancers and be able to receive immunotherapy and chemotherapy. People with other serious health issues or who can't safely get the study drugs may not qualify.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- 2141-V11
- Fluoropyrimidine
- Nivolumab
Trial Overview
The study tests if adding a new drug called 2141-V11 (given directly into tumors) to standard treatment—nivolumab (an immunotherapy) with or without fluoropyrimidine chemo—is safe for people with these cancers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Lead-in cohort. The intervention will be considered safe if DLT's are observed in \<2 of the first 6 patients enrolled; the observation of 2 or more DLTs in the first 6 patients will trigger dose deescalation to dose level -1 (3 mg); should this occur, 6 more patients will be enrolled at dose level -1. If 2 or more DLT's are then observed at dose level -1, the study will be paused and accrual will be stopped to reconsider 2141-V11 dosage.
Should the intervention prove to be safe, the phase II component can be initiated with an expansion cohort.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Rockefeller University
Collaborator
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