Study on Nivolumab for Treating Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and Non-Hodgkin Lymphomas

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03258567

Provider View

This clinical trial is exploring whether the drug Nivolumab can help slow down or stop the growth of certain cancers linked to the Epstein-Barr Virus (EBV) in people aged 12 and older who have no other standard treatment options.

Patient Parameters

Program Overview

The study aims to find out if Nivolumab, a drug already approved for some cancers, can help control the growth of cancers associated with the Epstein-Barr Virus (EBV) that have not responded to other treatments. Researchers will also assess the safety of Nivolumab in these cases. Participants will undergo various tests and receive Nivolumab every two weeks. After treatment, they will have regular follow-up visits to monitor their health and the effects of the drug.

Description

Epstein-Barr Virus (EBV) is linked to certain types of cancers, known as lymphoproliferative disorders (LPD) and non-Hodgkin lymphomas (NHL). These cancers often have a defect in the immune system's ability to fight them. Nivolumab is a drug that blocks a protein called PD-1, which can help the immune system attack cancer cells. This study will test if Nivolumab can help treat EBV-positive LPD and NHL.

Participants will receive Nivolumab through an IV every two weeks for up to two years, as long as the cancer is responding and there are no severe side effects. If the cancer returns within a year after stopping the drug, participants may be eligible for re-treatment. The study will include up to 40 participants to ensure enough data is collected.

Participants will have regular check-ups, including physical exams, blood tests, and scans, to monitor their response to the treatment. After completing the treatment, they will have follow-up visits every few months to continue monitoring their health.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of EBV-positive lymphoproliferative disorder (LPD) or non-Hodgkin lymphoma (NHL).
  • Must be at least 12 years old.
  • Must have adequate bone marrow function, unless the disease affects it.
  • Must be at least two weeks from any previous cancer treatment and 100 days from any stem cell transplant.
  • Must have measurable or evaluable disease.
  • Must have adequate organ and bone marrow function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Must be willing to provide a tumor sample for research purposes.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot be receiving any other experimental treatments.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot have another active cancer requiring treatment.
  • Cannot be taking high doses of steroids or other immune-suppressing drugs.
  • Cannot have active graft-versus-host disease or have had a solid organ transplant.
  • Cannot have previously received certain immune therapies.
  • Cannot have uncontrolled medical conditions or seizures.
  • Cannot have active hepatitis B or C infections.
  • Cannot be HIV positive due to potential immune system issues.

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