drugset / Trial / NCT05272384

Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma

NCT05272384

Phase 1 Recruiting 32 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial tests the safety, side effects, and best dose of nivolumab in combination with ASTX727 in treating B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). 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. ASTX727 consists of the combination of decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Giving nivolumab in combination with ASTX727 may shrink and stabilize cancer.

Timeline

Start
2022-11-03
Primary completion
2027-06-28
Completion
2027-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cedazuridine Small molecule Oral
Subject Decitabine Small molecule Oral
Subject Nivolumab Monoclonal antibody Intravenous