drugset / Trial / NCT03918499

IRX-2, Cyclophosphamide, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer

NCT03918499

NaSingle-groupOpen-labelTreatment

Summary

This phase Ib/II trial studies the side effects of IRX-2, cyclophosphamide, and pembrolizumab work in treating participants with gastric or gastroesophageal junction cancer that has come back or that has spread to other places in the body. Interleukins, such as those found in IRX-2, are proteins made by white blood cells and other cells in the body and may help regulate immune response. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving RX-2, cyclophosphamide, and pembrolizumab may work better in treating participants with gastric or gastroesophageal junction cancer.

Timeline

Start
2019-04-19
Primary completion
2023-02-09
Completion
2023-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Intravenous
Subject IRX-2 Protein / enzyme biologic Subcutaneous
Subject Pembrolizumab Monoclonal antibody Intravenous