Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: National Cancer Institute (NCI)
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
Birmingham
Duarte · Sacramento
New Haven
Chicago · New Lenox · Orland Park
Mineola · New York
Source: ClinicalTrials.gov · NCT05272384 · last updated 2026-05-13