Actively Recruiting
Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug Nivolumab to see if it can slow the growth or stop the progression of certain Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders and EBV-positive non-Hodgkin lymphomas, especially in patients who have not responded to chemotherapy or other treatments. The study also aims to evaluate the safety of Nivolumab in these conditions. This is a phase 2 trial sponsored by the National Cancer Institute (NCI). Participants will receive Nivolumab intravenously, either 3 mg/kg every 2 weeks or 480 mg every 4 weeks, for up to 2 years if their disease responds and they tolerate the treatment. Those who respond but later relapse within one year may be eligible for re-treatment. The study includes detailed screening and monitoring procedures such as physical exams, blood and urine tests, imaging scans, biopsies, and pregnancy tests. Throughout the study, participants will have regular assessments including physical exams, blood tests, and reviews of side effects every two weeks during treatment. After stopping treatment, visits will occur every 3 months for one year, then every 6 months for years 2 to 5, and annually thereafter. Researchers will measure overall response to the drug, monitor side effects, and track progression-free and overall survival over time.
CONDITIONS
Brief 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...
- Histologically or cytologically confirmed EBV-positive lymphoproliferative disorder or EBV-positive non-Hodgkin lymphoma confirmed by NCI Laboratory of Pathology
- EBV-positive LPD subjects may be untreated or relapsed; EBV-positive B-cell NHL subjects must have relapsed from prior anthracycline and rituximab treatment or be ineligible for it
- At least 12 years of age
- Patients aged 12 to less than 18 years must weigh at least 40 kilograms; no weight requirement for adults
- Adequate performance status: ECOG 0-2 for age 16 and older, Lansky 60-100% for under 16
- Measurable or evaluable disease
- Adequate bone marrow and organ function as defined by specific blood count and chemistry criteria
- Available tumor tissue sample or willingness for pre-treatment biopsy if needed
- Women of childbearing potential must have negative pregnancy tests and use contraception; men with partners who are WOCBP must use contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving other investigational agents
- History of allergic reactions to similar compounds as Nivolumab
- Second malignancies requiring active systemic therapy; pre-malignant conditions may be allowed
- Autoimmune diseases needing systemic corticosteroids above 10 mg prednisone or immunosuppressives within 14 days
- Active graft-versus-host disease or history of significant acute or chronic GVHD
- History of solid organ transplant
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- Recent non-oncology vaccine therapies within 4 weeks
- Serious uncontrolled medical conditions requiring therapy
- Uncontrolled seizure disorder
- Positive Hepatitis B surface antigen or active Hepatitis C infection
- History of anaphylactic reaction to monoclonal antibody therapy
- HIV positive status due to impaired T-cell immune function
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive nivolumab 480 mg intravenously every 4 weeks for up to 2 years if their disease is responding and they tolerate the treatment.
Monthly visits for treatment administration
Duration - Up to 1 year after treatment discontinuation
Participants who respond to treatment and then relapse or progress within 1 year after stopping nivolumab are eligible for re-treatment.
Visits as needed for monitoring and potential re-treatment
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
C
Christopher J Melani, M.D.
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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