Clinical Trial Goal
To find out if nivolumab is safe and works well to treat EBV+ NHL that has come back (relapsed) or did not get better after treatment (refractory) or EBV+ lymphoproliferative disorders
You may be able to join this trial if you:
- Are 12 years old or older
- Have one of the following diseases that is EBV+ (your doctor can tell you this):
- DLBCL that has relapsed or is refractory
- Lymphomatoid granulomatosis
- Post-transplant lymphoproliferative disorder (PTLD)
- Have not been treated with a drug that targets PD-1, PD-L1, PD-L2, CTLA-4, or CD137. Your doctor can tell you this
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Nivolumab is a monoclonal antibody that targets PD-1 on certain cells.
You’ll get:
You’ll get:
- Nivolumab – Given as an intravenous (IV) infusion 1 time every 4 weeks. Each infusion takes about 30 minutes
You may continue treatment for up to 2 years. You’ll have a procedure that collects some of your spinal fluid using a needle in your lower back (lumbar puncture).
You’ll also have scans and biopsies to see how well the treatment is working. After you finish treatment, the clinical trial doctors will check your health every 3 months for 1 year, then every 6 months for 5 years.
The Food and Drug Administration (FDA) has approved nivolumab to treat Hodgkin lymphoma. Using it to treat EBV+ DLBCL or EBV+ lymphoproliferative disorders is new and unproven.
Contacts
NCI Medical Oncology Referral Office, (240) 760-6050, ncimo_referrals@nih.gov
Christopher J Melani, M.D., (240) 760-6057, christopher.melani@nih.gov
Locations
National Institutes of Health Clinical CenterRECRUITING
Bethesda, Maryland
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
Sponsors
lead: National Cancer Institute (NCI)
