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

NCT03258567 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-22

No results posted yet for this study

Summary

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

  • Epstein-Barr Virus Infections
  • Lymphoma
  • Lymphoproliferative Disorder
  • Disorders, Lymphoproliferative

Interventions

BIOLOGICAL

Nivolumab

Nivolumab, 480 mg IV every 4 weeks for up to 2 years in subjects with responding disease with clinical benefit if they are tolerating treatment

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christopher J Melani, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2029-06-01
Completion
2031-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258567 on ClinicalTrials.gov