drugset / Trial / NCT03655002

IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer

NCT03655002

NaSingle-groupOpen-labelTreatment

Summary

This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment. Biological therapies, such as IRX-2, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. 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 nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving IRX-2, cyclophosphamide, and nivolumab may work better than the IRX?2 regimen alone in treating patients with hepatocellular carcinoma.

Timeline

Start
2019-02-21
Primary completion
2027-03-02
Completion
2027-03-02

Drugs

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