Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Research Center for Hematology, Russia

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Uncontrolled bacterial or fungal infection at the time of enrollment

Requirement for vasopressor support at the time of enrollment

Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms

Karnofsky index <30%

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • Doxorubicin Hydrochloride
  • Etoposide Phosphate
  • Prednisolone
  • Rituximab
  • Vincristine Sulfate
  • Filgrastim
  • Pegfilgrastim
  • Nivolumab 40 mg in 4 ml Injection

Treatment groups

100 Participants
are divided into 2 treatment groups