NCT06188676

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

Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Mediastinal Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Ciclofosfamida
DRUG	Doxorubicin Hydrochloride	Adriamycin
DRUG	Etoposide Phosphate	Etopophos
DRUG	Prednisolone	Prednisolonum
DRUG	Rituximab	Chimeric Anti-CD20 Antibody
DRUG	Vincristine Sulfate	Oncovin
DRUG	Filgrastim	G-CSF
DRUG	Pegfilgrastim	PEG-filgrastim
DRUG	Nivolumab 40 mg in 4 ml Injection	Opdivo

Timeline

• Start date: 2022-04-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: Russia