Phase 1 Study of Nivolumab with ASTX727 to Treat Relapsed or Refractory B-Cell Lymphoma Including Diffuse Large B-Cell and Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the combination of nivolumab and ASTX727 in treating adults with relapsed or refractory B-cell lymphoma, including diffuse large B-cell lymphoma DLBCL and Hodgkin lymphoma HL. This phase I trial aims to determine the safety, side effects, and optimal dose of this treatment approach, which uses immunotherapy and DNA methyltransferase inhibition to help the immune system attack cancer cells and interfere with tumor growth. The study also explores how these treatments affect immune responses and tumor characteristics. Participants receive decitabine and cedazuridine orally once daily on days 1 to 3 or 1 to 5 of each 28-day cycle, combined with intravenous nivolumab on day 15. Treatment continues for 12 cycles unless the disease progresses or unacceptable side effects occur. Those showing complete response, partial response, or stable disease after 12 cycles may receive decitabine and cedazuridine for an additional 12 months. Throughout the trial, patients undergo PETCT scans and blood sample collection to monitor their condition. During the study, patients are assessed for safety and treatment effects up to two years, including monitoring for adverse events, tumor response, progression-free survival, and overall survival. Researchers also analyze changes in immune cell activity, tumor DNA mutations, and DNA methylation patterns. After completing treatment, participants have follow-up visits every three months for two years to track long-term outcomes and safety.

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