Actively Recruiting
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
32
Participants Needed
9
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed relapsed or refractory B cell lymphoma (NHL or HL) for dose escalation
- Histologically confirmed relapsed or refractory DLBCL or HL for dose expansion
- DLBCL patients must have failed first line chemotherapy and be transplant ineligible
- Patients may be relapsed after stem cell transplant or CAR-T therapy
- HL or other B cell NHL (non-DLBCL) patients must have relapsed after at least 2 therapy lines with no curative options
- HL patients must be brentuximab vedotin refractory or intolerant
- HL patients in dose expansion must have relapsed after at least 2 therapies and have had or be ineligible for autologous stem cell transplantation
- Prior checkpoint inhibitor treatment allowed
- ECOG/Karnofsky performance status of 2 or less (Karnofsky 70% or higher)
- Leukocytes at least 1,500/mcL unless bone marrow involvement
- Absolute neutrophil count at least 1,000/mcL unless bone marrow involvement
- Platelets at least 75,000/mcL unless bone marrow involvement
- Total bilirubin no higher than 1.5 times institutional upper limit
- AST/ALT no higher than 3 times institutional upper limit
- Serum creatinine no higher than 1.5 times upper limit or creatinine clearance at least 50 mL/min
- No systemic corticosteroids over 10 mg prednisone equivalents or other immunosuppressive treatment within 14 days
- HIV patients on effective treatment with undetectable viral load within 6 months
- Controlled hepatitis B or cured hepatitis C with undetectable viral load
- Treated brain metastases allowed if no progression
- Active brain metastases allowed if no immediate CNS treatment needed
- Prior malignancies in remission for at least 3 years or non-melanoma skin/in situ cancer allowed
- New York Heart Association class 2B or better
- Use of highly effective contraception for women of childbearing potential and men during and after study per protocol
- Ability to understand and sign informed consent or have a legally authorized representative
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks prior to study (except limited-field palliative radiation meeting criteria)
- Not recovered from prior anti-cancer treatment side effects above grade 1 except alopecia
- Prior anti-PD-1/PD-L1 or anti-CTLA4 antibody treatment discontinued due to adverse events
- Receiving other investigational agents
- Known brain or leptomeningeal metastases with poor prognosis or neurologic dysfunction
- Allergic reactions to similar drugs including severe hypersensitivity to monoclonal antibodies
- Uncontrolled intercurrent illness
- Cognitive or other impairments preventing study compliance
- Pregnant or breastfeeding women
- Active autoimmune diseases affecting vital organs or requiring immune suppressive therapy
- History of immune-related neurologic or systemic autoimmune diseases with recurrence risk
- Patients with vitiligo, endocrine deficiencies managed with replacement hormones, controlled rheumatoid arthritis and other arthropathies, Sjogren's syndrome, psoriasis controlled with topical meds, or positive serology without organ involvement may be eligible
- History of severe skin reactions such as toxic epidermal necrolysis or Stevens-Johnson syndrome
- Evidence of active diverticulitis, intra-abdominal abscess, GI obstruction, or abdominal carcinomatosis without treatment evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
7
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
8
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
9
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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