Actively Recruiting
Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas
Led by National Cancer Institute (NCI) · Updated on 2026-05-07
40
Participants Needed
1
Research Sites
683 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments. Objectives: To see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug. Eligibility: People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy Design: Participants will be screened with: Medical history Physical exam Blood and urine tests CAT scan of the chest, abdomen, and pelvis Tumor and bone marrow biopsies (sample taken) Magnetic resonance imaging scan of the brain Lumbar puncture (also known as spinal tap) Positron emission tomography/computed tomography scan with a radioactive tracer Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have: Physical exam Blood and pregnancy tests Review of side effects and medications During the study, participants will repeat most of the screening tests. They may also have other biopsies. After stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.
CONDITIONS
Official Title
Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have confirmed EBV-positive lymphoproliferative disorder (LPD) or EBV-positive non-Hodgkin lymphoma (NHL) verified by NCI Laboratory of Pathology
- EBV-positive LPD patients may be untreated or relapsed from prior therapy
- EBV-positive B-cell NHL patients must have relapsed after anthracycline and rituximab treatment or be ineligible for it
- At least 12 years old
- Patients aged 12-17 years must weigh at least 40 kilograms
- At least 2 weeks since last anti-lymphoma therapy
- At least 100 days since stem cell transplant or donor lymphocyte infusion
- Adequate performance status (ECOG 0-2 for patients 16 years and older; Lansky score 60-100% for younger patients)
- Measurable or evaluable disease
- Adequate organ and bone marrow function unless caused by disease
- Availability of tumor tissue sample for studies
- Women of childbearing potential must have negative pregnancy test and use contraception; men must use contraception if sexually active with such women
- Ability to understand and sign informed consent
You will not qualify if you...
- Currently receiving other investigational agents
- History of allergic reaction to drugs similar to nivolumab
- Active second cancers requiring systemic therapy (except certain pre-malignant conditions)
- Autoimmune disease requiring systemic corticosteroids or immunosuppressants within 14 days
- Active graft-versus-host disease needing steroids or immunosuppressants, or history of significant GVHD
- Prior solid organ transplant
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- Non-oncology vaccine within 4 weeks before study drug
- Serious uncontrolled medical condition
- Uncontrolled seizure disorder
- CNS involvement with seizures in past 4 weeks
- Positive hepatitis B surface antigen
- Active hepatitis C infection by PCR
- History of anaphylaxis to monoclonal antibodies
- HIV positive status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
CONTACT
C
Christopher J Melani, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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