Phase 2 Study of Nivolumab Treatment for Epstein-Barr Virus Positive Lymphoproliferative Disorders and Non-Hodgkin Lymphomas

What this Trial Is About

Researchers are studying Nivolumab, a drug approved for some cancers, to evaluate its effects on Epstein-Barr Virus EBV-positive lymphoproliferative disorders LPD and EBV-positive non-Hodgkin lymphomas NHL that have not responded to standard treatments. This phase 2 study aims to see if Nivolumab can slow or stop cancer progression and assess its safety in patients 12 years and older with these conditions. EBV-positive LPDs and NHLs share immune system features, and Nivolumab targets the PD-1 pathway involved in immune regulation for potential clinical benefit. Participants receive Nivolumab intravenously at 480 mg every 4 weeks for up to 2 years if their disease responds and they tolerate treatment well. Those who initially respond but relapse within one year after stopping treatment may be eligible for re-treatment. The study includes comprehensive initial screening with physical exams, imaging scans, biopsies, and lab tests. During treatment, participants undergo regular physical exams, blood and pregnancy tests, and side effect evaluations. If responding, treatment continues with ongoing monitoring. After treatment ends, participants have follow-up visits every 3 months for the first year, then every 6 months for years 2 to 5, and annually thereafter. Follow-up includes physical exams and blood tests to monitor health and disease status. The primary outcome is to measure the overall response rate to Nivolumab at one year. Additional assessments track safety, progression-free survival, overall survival, and remission duration. The study involves careful safety monitoring, including pregnancy testing and contraception requirements for those of childbearing potential.

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