Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non… (NCT03258567) | Clinical Trial Compass
RecruitingPhase 2
Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas
United States40 participantsStarted 2018-04-26
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Lymphomatoid granulomatosis (LYG), grades I-II
. Chronic active EBV disease (CAEBV) of B-cells or T-cells
. EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)
. EBV-positive DLBCL
. Amenorrhea \>= 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL
. Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL or NOTE: FSH level testing is not required for women \>= 62 years old with amenorrhea of \>= 1 year