Title: Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Principal Investigator: Lisa G. Roth, MD, Children’s Oncology Group
Description: Investigators are conducting a phase 3 trial of nivolumab in combination with various chemoimmunotherapy (CIT) regimens, compared with the CIT regimens alone, in children and adults with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL).
The participants are randomly assigned to receive a backbone therapy or backbone therapy plus nivolumab across 6 arms. Patients in arm A receive dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). Patients in arm B receive DA-EPOCH-R plus nivolumab.
Patients in arm C receive rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Patients in arm D receive R-CHOP plus nivolumab. Patients in arm E receive R-CHOP plus radiotherapy (RT). Patients in arm F receive R-CHOP plus RT and nivolumab.
The primary endpoint is progression-free survival. Key secondary endpoints include efficacy-related event-free survival (EFS), therapy-related EFS, and overall survival.
To be eligible for this study, patients must be 2 years of age or older and have histologically confirmed PMBCL, as defined by World Health Organization criteria. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by the National Cancer Institute.
Clinicaltrials.gov. Nivolumab in combination with chemo-immunotherapy for the treatment of newly diagnosed primary mediastinal B-cell lymphoma. NCT04759586. Accessed December 15, 2021.