Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Joseph M. Tuscano (ucdavis)

Description

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.

Official Title

A Phase 1 Study of Nivolumab in Combination With ASTX727 in B-cell Lymphoma (NHL or HL) With an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Hodgkin Lymphoma (HL)

Details

Keywords

Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Hodgkin Lymphoma, Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Recurrence, Nivolumab, Decitabine, Decitabine and cedazuridine drug combination, Biospecimen Collection, Computed Tomography, Decitabine and Cedazuridine, Positron Emission Tomography

Eligibility

Locations

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Joseph M. Tuscano (ucdavis)
    Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 116 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT05272384
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated