RecruitingPhase 1NCT05272384

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

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)


Sponsor

National Cancer Institute (NCI)

Enrollment

32 participants

Start Date

Nov 3, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining nivolumab (an immunotherapy drug) with ASTX727 (a DNA-modifying drug) for people with B-cell lymphoma or Hodgkin lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You have relapsed or treatment-resistant diffuse large B-cell lymphoma (DLBCL) or Hodgkin lymphoma - For DLBCL: you have failed at least one prior chemotherapy and are not eligible for a stem cell transplant - For Hodgkin lymphoma: you have relapsed after at least 2 prior therapies, and are not eligible for or have already had an autologous stem cell transplant - You have measurable disease by imaging **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You have significant heart disease - You have uncontrolled infections - You are pregnant or breastfeeding - You have HIV or active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo PET/CT

DRUGDecitabine and Cedazuridine

Given PO

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(9)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Yale University

New Haven, Connecticut, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05272384


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