Nivolumab for EBV-Positive Lymphoma and Lymphoproliferative Disorders
This study is testing a drug called Nivolumab for people with Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders (LPD) or EBV-positive non-Hodgkin lymphomas (NHL). Nivolumab is already approved for some cancers, and researchers want to see if it can slow the growth of these specific EBV-related cancers, especially if other treatments haven't worked. You might be able to join if you are 12 years or older and have a confirmed diagnosis of one of these EBV-positive conditions. The main goal is to see how many patients respond to Nivolumab over one year. The study is currently recruiting about 40 participants, but its overall status is unclear.
- Study design
- This study is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified.
- What's involved
- You would undergo a medical history, physical exam, blood and urine tests, CAT scans, and tumor and bone marrow biopsies. If you respond to treatment and tolerate it well, you would receive Nivolumab intravenously every 4 weeks for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, overall response rate, is measured at one year.
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NCT03258567
Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas
Recruiting
PHASE2Ages 12+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~40 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Nivolumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL
Measured over one year
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Christopher J Melani, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI.
EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy.
EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same.
Subjects must be at least 2 weeks from prior anti-lymphoma therapy (including radiation therapy)
Subjects must be at least 100 days from prior stem cell transplant (autologous or allogeneic) or Donor Lymphocyte Infusion (DLI)
Age \>=12 years
Patients \>= 12 and \< 18 years of age should weigh at least 40 kilograms (kg); there is no weight requirement for adult subjects.
NOTE: If a pediatric patient is identified for possible enrollment who weighs less than 40 kg, the safety of the nivolumab dosing strategy used in this study must be discussed with the PI and manufacturer to confirm safety, and this discussion/approval for enrollment documented in the medical record prior to declaring the pediatric patient eligible.
Adequate performance status as follows:
Patients \>= 16 years must have ECOG Performance Status 0-2 (Karnofsky \>=60%)
Pediatric patients \< 16 years must have Lansky play-performance of 60-100%
Subjects must have measurable or evaluable disease.
Subjects must have adequate organ and bone marrow reserve (unless disease-related) as defined below:
absolute neutrophil count - \>= 750/mcL; \>= 500/mcL if impairment is due to LPD/NHL
platelets - \>= 50,000/mcL; \>= 25,000/mcL if impairment is due to LPD/NHL (transfusions not permitted)
Hemoglobin - \>= 9g/dL (transfusion permitted)
total bilirubin - \< 3.0g/dl OR \< 5.0g/dl if Gilbert s syndrome or disease infiltration of the liver is present
AST(SGOT)/ALT(SGPT) - \<= 3 X institutional upper limit of normal
serum creatinine OR creatinine clearance - Adults: \<= 1.5 mg/dL; Minors: serum Cr \<= age-adjusted normal OR \>= 40 ml/min/1.73m\^2
A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available.
The toxicity profile of nivolumab in patients with disease involvement of the central nervous system (CNS) is unknown. For this reason, we will introduce early stopping rules.
The effects of nivolumab on the developing human fetus are unknown. For this reason, the following measures apply:
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) during screening and within 48 hours prior to the first dose of nivolumab.
WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or 2 barrier methods with a failure rate of less than 1% per year or abstinence) prior to study entry and throughout study drug administration. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).
WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal. Post menopause is defined as:
Pregnant women are excluded from this study because nivolumab is an IgG monoclonal antibody 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 nivolumab, nursing should be discontinued if the mother is treated with nivolumab.
Ability of subject or Legally Authorized Representative (LAR) to understand and sign the written informed consent document.
Exclusion
Subjects who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
Subjects with second malignancies requiring active systemic therapy are excluded. Subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible.
Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.
Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \>=grade II acute GVHD or extensive chronic GVHD.
Subjects who have had solid organ transplant.
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody.
Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.
A serious uncontrolled medical condition requiring therapy.
Seizures disorder not controlled by anti-seizure medications.
Subjects with CNS involvement may be included on the study as long as they have not had any seizure activity in past 4 weeks.
Hepatitis B virus surface antigen positive.
Active Hepatitis C infection with a positive PCR; subjects who are Hepatitis C antibody positive and PCR negative may be eligible. In these cases, the subjects will be monitored via HCV PCR throughout the study.
History of anaphylactic reaction to monoclonal antibody therapy.
HIV positive subjects are excluded because the function of their T-cell immune responses is impaired.
What this trial measures
- overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHLone year
number of patients who respond to the protocol therapy (CR, PR, SD)