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Hypomethylation Agent
Nivolumab + ASTX727 for B-Cell Lymphoma
Phase 1
Recruiting
Led By Catherine S Diefenbach
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status =< 2 (Karnofsky >= 80%)
Dose Expansion: Patients must have histologically confirmed relapsed or refractory DLBCL
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of nivolumab and ASTX727 in patients with B-cell lymphoma that has come back or is not responding to treatment. Nivolumab helps the immune system attack cancer, while ASTX727 enhances the effectiveness of another drug. The goal is to find a safe and effective dose for these patients.
Who is the study for?
Adults with relapsed or refractory B-cell lymphoma, including DLBCL, who have tried at least one other treatment and are not eligible for a transplant. They must be in relatively good health (ECOG/Karnofsky >=80%), have certain blood cell counts, no severe liver or kidney issues, and no uncontrolled illnesses. HIV-positive patients on effective therapy can join; those with hepatitis must be treated. Participants must agree to use effective contraception.
What is being tested?
The trial is testing the safety and optimal dosage of Nivolumab combined with ASTX727 (Decitabine and Cedazuridine) for B-cell lymphoma that's returned or hasn't responded to treatment. The goal is to see if this combo can help the immune system fight cancer better by stopping tumor growth.
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving drugs through a vein, fatigue, digestive problems like stomach pain or constipation, changes in blood cells leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly self-sufficient and can carry out daily activities.
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My DLBCL has returned or did not respond to treatment.
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My hepatitis B virus is undetectable with treatment.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am not on high-dose steroids or other immune-weakening medicines.
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My heart condition does not severely limit my daily activities.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am 18 years old or older.
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My B cell lymphoma has come back or did not respond to treatment.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
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I do not have an active or history of severe autoimmune disease that could worsen.
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I was taken off anti-PD-1/PD-L1 or anti CTLA4 treatments due to side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Complete response rate
Duration of response
Overall response rate
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, decitabine and cedazuridine)Experimental Treatment5 Interventions
Patients receive decitabine and cedazuridine PO QD on days 1-3 or 1-5 of each cycle and nivolumab IV over 30 minutes on day 15 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2011
Completed Phase 2
~2200
Nivolumab
2015
Completed Phase 3
~4010
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hodgkin's Lymphoma include immunotherapy with monoclonal antibodies and hypomethylation agents. Immunotherapy, such as Nivolumab, works by enhancing the body's immune system to recognize and attack cancer cells.
Monoclonal antibodies specifically target proteins on the surface of cancer cells, marking them for destruction by the immune system. Hypomethylation agents like Decitabine, often combined with cytidine deaminase inhibitors like Cedazuridine, work by reactivating tumor suppressor genes that have been silenced by abnormal DNA methylation, thereby inhibiting cancer cell growth.
These treatments are crucial for Hodgkin's Lymphoma patients as they offer targeted approaches that can improve the effectiveness of the immune response and potentially lead to better outcomes with fewer side effects compared to traditional chemotherapy.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,024,347 Total Patients Enrolled
Catherine S DiefenbachPrincipal InvestigatorLaura and Isaac Perlmutter Cancer Center at NYU Langone
3 Previous Clinical Trials
173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain scans show no worsening after treatment for brain metastases.I am mostly self-sufficient and can carry out daily activities.I am not pregnant or breastfeeding.Your platelet count should be at least 75,000/mcL, unless you have bone marrow involvement, in which case lower values may be allowed.I can understand and am willing to sign the consent form, or I have someone who can do it for me.My white blood cell count is at least 1,000, unless my bone marrow is affected.My DLBCL has returned or did not respond to treatment.My doctor says I don't need immediate brain treatment for my cancer.The amount of bilirubin in your body is within the normal range.You cannot be taking any experimental drugs at the same time.My hepatitis B virus is undetectable with treatment.I had cancer before, but it's been in remission or treated over 3 years ago, except for skin cancer or localized cancer.I have DLBCL, failed first chemotherapy, can't have a transplant, and may have tried stem cell or CAR-T therapy.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have recovered from side effects of previous cancer treatments, except for hair loss.I do not have cancer spread to my brain or its coverings.I have been checked for serious gut issues before joining the study.I am not on high-dose steroids or other immune-weakening medicines.My heart condition does not severely limit my daily activities.I am a woman who can still have children, not sterilized, and not in menopause.I will use contraception for the required time after my last dose.I was taken off anti-PD-1/PD-L1 or anti CTLA4 treatments due to side effects.I agree to use effective birth control during and after the study.I do not have an active or history of severe autoimmune disease that could worsen.You have had allergic reactions to drugs with similar chemical or biological makeup as ASTX727 or nivolumab, including severe reactions to monoclonal antibodies.You must have a certain level of white blood cells in your blood, unless there is a documented bone marrow issue.My kidney function, measured by creatinine levels or clearance, is within the required range.I am HIV-positive, on treatment, and my viral load is undetectable.I have HL or B cell NHL, failed 2 treatments, and can't or won't do a stem cell transplant.I am 18 years old or older.I haven't had chemotherapy or major radiation in the last 4-6 weeks, but may have had small-area radiation if it didn't target a main cancer spot and no new bone metastases were found.My B cell lymphoma has come back or did not respond to treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, decitabine and cedazuridine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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