Actively Recruiting
A Phase 1 Study of Nivolumab Combined With ASTX727 for Relapsed or Refractory B-Cell Lymphoma Including DLBCL and Hodgkin Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
32
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of nivolumab and ASTX727 in treating adults with relapsed or refractory B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and Hodgkin lymphoma (HL). This phase I trial aims to determine the safety, side effects, and optimal dose of this treatment approach, which uses immunotherapy and DNA methyltransferase inhibition to help the immune system attack cancer cells and interfere with tumor growth. The study also explores how these treatments affect immune responses and tumor characteristics. Participants receive decitabine and cedazuridine orally once daily on days 1 to 3 or 1 to 5 of each 28-day cycle, combined with intravenous nivolumab on day 15. Treatment continues for 12 cycles unless the disease progresses or unacceptable side effects occur. Those showing complete response, partial response, or stable disease after 12 cycles may receive decitabine and cedazuridine for an additional 12 months. Throughout the trial, patients undergo PET/CT scans and blood sample collection to monitor their condition. During the study, patients are assessed for safety and treatment effects up to two years, including monitoring for adverse events, tumor response, progression-free survival, and overall survival. Researchers also analyze changes in immune cell activity, tumor DNA mutations, and DNA methylation patterns. After completing treatment, participants have follow-up visits every three months for two years to track long-term outcomes and safety.
CONDITIONS
Brief 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 (non-Hodgkin lymphoma or Hodgkin lymphoma)
- For diffuse large B-cell lymphoma (DLBCL), patients must have failed at least first line chemotherapy and be transplant ineligible or relapsed after stem cell transplant or CAR-T therapy
- For Hodgkin lymphoma, patients must have relapsed after at least 2 lines of therapy and be autologous stem cell transplant ineligible or have refused transplant
- Performance status ECOG 0-2 or Karnofsky 70% or higher
- Leukocytes at least 1,500/mcL, absolute neutrophil count at least 1,000/mcL, and platelets at least 75,000/mcL unless bone marrow involvement
- Liver enzymes and kidney function within specified limits
- No systemic corticosteroids above 10 mg prednisone equivalents or other immunosuppressive treatments within 14 days before study
- HIV patients on effective therapy with undetectable viral load within 6 months
- Treated or cured hepatitis B or C infection with undetectable viral load if applicable
- Treated brain metastases with no progression or stable brain metastases not requiring immediate treatment
- Prior malignancies in remission for at least 3 years allowed
- New York Heart Association Functional Classification class 2B or better
- Women and men must use highly effective contraception during and after study participation as specified
- 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 entry (2 weeks for Revlimid, 6 weeks for nitrosoureas or mitomycin C)
- Not recovered from prior treatment side effects above grade 1 except alopecia
- Prior treatment with anti-PD-1/PD-L1 or anti-CTLA4 antibodies discontinued due to adverse events
- Receiving other investigational agents
- Known active brain metastases or leptomeningeal metastases with poor prognosis
- History of severe allergic reactions to similar drugs including monoclonal antibodies
- Uncontrolled illnesses
- Cognitive impairment preventing study compliance
- Pregnant or breastfeeding women
- Active autoimmune diseases requiring systemic immunosuppressive treatment, except certain controlled conditions
- Recent serious gastrointestinal conditions increasing risk for bowel perforation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 cycles of 28 days each
Participants receive oral decitabine and cedazuridine daily on days 1-3 or 1-5 and an intravenous infusion of nivolumab on day 15 of each 28-day cycle. Treatment repeats every 28 days for 12 cycles unless disease progresses or unacceptable side effects occur. Participants also undergo PET/CT scans and blood sample collections during treatment.
Monthly visits for up to 12 months
Duration - Up to 12 additional months
Participants with complete response, partial response, or stable disease after 12 cycles continue oral decitabine and cedazuridine treatment for an additional 12 months. PET/CT scans and blood sample collections continue throughout this period.
Monthly visits for up to 12 months
Duration - 2 years
After completing treatment, participants are followed every 3 months to monitor their health and collect safety and survival information.
Quarterly visits for 2 years
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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