RecruitingPhase 2NCT03258567

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

Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas


Sponsor

National Cancer Institute (NCI)

Enrollment

40 participants

Start Date

Apr 26, 2018

Study Type

INTERVENTIONAL

Conditions

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. ...


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing nivolumab (an immunotherapy drug that helps the immune system attack cancer) in patients with certain types of lymphoma or abnormal lymph tissue growths caused by the Epstein-Barr virus (the virus that causes mononucleosis). **You may be eligible if...** - You are 12 years or older (and weigh at least 40 kg if under 18) - You have a confirmed diagnosis of an EBV-related lymphoma or abnormal lymph tissue growth (such as lymphomatoid granulomatosis, chronic active EBV disease, post-transplant lymphoproliferative disorder, or EBV-positive large B-cell lymphoma) - Your disease has not responded to previous treatment, or you have relapsed - Your organs (liver, kidneys, bone marrow) are functioning well enough **You may NOT be eligible if...** - You have had a solid organ transplant (kidney, liver, heart, etc.) - You are currently receiving immunosuppressive medications (like steroids) for an autoimmune condition - You are HIV positive - You have active hepatitis B or C - You have previously received checkpoint immunotherapy drugs (anti-PD-1, anti-CTLA-4) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNivolumab

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


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03258567


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