Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas

Recruiting now · Phase 2

Conditions studied: Epstein-Barr Virus Infections, Lymphoma, Lymphoproliferative Disorder, Disorders, Lymphoproliferative

In brief

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. ...

Key facts

Study ID: NCT03258567
Run by: National Cancer Institute (NCI)
People needed: 40
Starts: 2018-04-26
Expected to finish: 2031-06-01
Last updated by the study team: 2026-07-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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