Testing Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
This study is testing the safety and best dose of two medicines, nivolumab and ASTX727, for people with B-cell lymphoma that has come back (relapsed) or isn't responding to treatment (refractory). Nivolumab is an immunotherapy that helps your body's immune system fight cancer. ASTX727 combines two drugs, decitabine and cedazuridine. Cedazuridine helps decitabine work better by preventing its breakdown in the body. Decitabine is a type of medicine that can affect how cancer cells grow. The study aims to see how safe this combination is and if it can shrink tumors. We are looking for about 32 participants aged 18 and older with specific types of B-cell lymphoma.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is designed to evaluate safety and tolerability in a small group of participants.
- What's involved
- You would provide blood samples and undergo PET/CT scans. You would receive nivolumab intravenously (through a vein) and ASTX727 orally (by mouth).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track adverse events (side effects) for up to two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05272384
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~32 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyDecitabine and CedazuridineNivolumabPositron Emission Tomography
At a glance
Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 2 years
Conditions
NCT05272384
Where you'd take part
This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope Comprehensive Cancer Center
Duarte, Californiastudy coordinator listed
Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New Yorkstudy coordinator listed
Recruiting
NYU Langone Hospital - Long Island
Mineola, New Yorkstudy coordinator listed
Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinoisstudy coordinator listed
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, Californiastudy coordinator listed
Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinoisstudy coordinator listed
Recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinoisstudy coordinator listed
Recruiting
Yale University
New Haven, Connecticutstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Catherine S Diefenbach · PRINCIPAL_INVESTIGATOR · Laura and Isaac Perlmutter Cancer Center at NYU Langone
Who to contact
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Eligibility criteria
Inclusion
Dose Escalation: Histologically confirmed relapsed or refractory B cell lymphoma (non-Hodgkin lymphoma \[NHL\] or Hodgkin lymphoma \[HL\])
Dose Expansion: Patients must have histologically confirmed relapsed or refractory DLBCL or HL
Patients with DLBCL must have failed at least first line chemotherapy and must be transplant ineligible (either secondary to performance status or lack of adequate disease control or patient preference). Patients may be relapsed after autologous or allogeneic stem cell transplant (SCT), or after chimeric antigen receptor (CAR)-T cell therapy
In dose escalation patients with HL or B cell NHL other than DLBCL must have relapsed after at least 2 lines of therapy and have no other curative options left. HL patients must be brentuximab vedotin refractory or intolerant. In dose expansion, patients with classic HL must have relapsed after at least 2 lines of therapy, and had autologous stem cell transplantation (ASCT), be ineligible for ASCT, or have refused ASCT. Prior treatment with checkpoint inhibitor is allowed
Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of nivolumab in combination with ASTX727 in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status =\< 2 (Karnofsky \>= 70%)
Leukocytes \>= 1,500/mcL (unless documented bone marrow involvement in which case lower values may be allowed)
Absolute neutrophil count \>= 1,000/mcL (unless documented bone marrow involvement in which case lower values may be allowed)
Platelets \>= 75,000/mcL (unless documented bone marrow involvement in which case lower values may be allowed)
Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
Serum creatinine =\< 1.5 x ULN OR creatinine clearance (CrCl) \>= 50 mL/min (if using the Cockcroft-Gault formula)
Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
Patients with a prior malignancy that has completed treatment and or in remission for at least 3 years, or non-melanoma skin cancer or in situ cancer are eligible for this trial. Patients with concurrent malignancy or recent treatment for a concurrent malignancy are not eligible
Patients should be New York Heart Association Functional Classification of class 2B or better
The effects of nivolumab and ASTX727 on the developing human fetus are unknown. For this reason and because DNMTi agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use a highly effective contraception method to avoid pregnancy during treatment with ASTX727 and for at least 6 months after the last dose of investigational drug and must agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to highly-effective contraceptive measures of birth control and not to father a child while receiving treatment and for a period of 3 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception
Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion
Patients who have had chemotherapy or radiotherapy within 4 weeks (2 weeks for Revlimid, 6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:
Repeat imaging demonstrates no new sites of bone metastases
The lesion being considered for palliative radiation is not a target lesion
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Patients who have had prior treatment with anti-PD-1/PD-L1 inhibitors or anti CTLA4 antibodies and were permanently discontinued from further treatment because of an adverse event. All other prior therapies are permissible. Prior checkpoint inhibitor therapy is allowed if there was no discontinuation due to adverse event
Patients who are receiving any other investigational agents
Patients with known brain metastases or leptomeningeal metastases may be excluded because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or nivolumab, including severe hypersensitivity reaction to any monoclonal antibody
Patients with uncontrolled intercurrent illness
Patients with cognitive or other impairment that would prevent compliance with study requirements
Pregnant women are excluded from this study because ASTX727 is a DNMTi agent and nivolumab is a PD-L1 inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ASTX727 and nivolumab, breastfeeding should be discontinued if the mother is treated with ASTX727 and nivolumab
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome (GBS), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study
What this trial measures
- Incidence of adverse eventsUp to 2 years
Frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0 terminology. Exact 95% confidence intervals around the toxicity proportions will be calculated.