OncoMatch/Clinical Trials/NCT05272384
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
Is NCT05272384 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Nivolumab and Decitabine and Cedazuridine for recurrent b-cell non-hodgkin lymphoma.
Treatment: Decitabine and Cedazuridine · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Hodgkin Lymphoma
Performance status
ECOG/KARNOFSKY 0–2
Prior therapy
Must have received: chemotherapy — first line
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
Must have received: chemotherapy — at least 2 lines
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.
Must have received: chemotherapy — at least 2 lines
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
Cannot have received: chemotherapy or radiotherapy (Revlimid, nitrosoureas, mitomycin C)
Exception: 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 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
Cannot have received: anti-PD-1/PD-L1 inhibitor or anti-CTLA4 antibody
Exception: Prior checkpoint inhibitor therapy is allowed if there was no discontinuation due to adverse event
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
Lab requirements
Blood counts
Leukocytes >= 1,500/mcL (unless documented bone marrow involvement in which case lower values may be allowed); ANC >= 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)
Kidney function
Serum creatinine <= 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3 x institutional ULN
Cardiac function
New York Heart Association Functional Classification of class 2B or better
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 ULN; AST/ALT <= 3 x institutional ULN; Serum creatinine <= 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula); New York Heart Association Functional Classification of class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- City of Hope Comprehensive Cancer Center · Duarte, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- Yale University · New Haven, Connecticut
- University of Chicago Comprehensive Cancer Center · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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