Phase 3Active, not recruiting
Nivolumab 40 mg in Combination With Chemo-Immunotherapy for Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
- Sponsor
- National Research Center for Hematology, Russia (Research network)
- Enrollment
- 60 enrolled
- Conditions
- Primary Mediastinal Lymphoma
- Interventions
- Cyclophosphamide; Doxorubicin Hydrochloride; Etoposide Phosphate; Prednisolone; Rituximab; Vincristine Sulfate; Filgrastim; Pegfilgrastim; Nivolumab 40 mg in 4 ml Injection
- Ages
- adults, older adults
- Registry
- NCT06188676
Full record on ClinicalTrials.gov
From the registry
This compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Primary outcomes
- Progression-free survival (PFS)
History
Primary completion expected
Last registry update
Registered
Started