Overview

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

Status:
Recruiting

Trial end date:
2029-04-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Research Center for Hematology, Russia

Treatments:

Cyclophosphamide
Doxorubicin
Etoposide
Etoposide phosphate
Liposomal doxorubicin
Nivolumab
Prednisolone
Rituximab
Vincristine

Criteria

Inclusion Criteria:

- Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as
defined by World Health Organization (WHO) criteria Age 18-70 years old Ejection fraction
greater than 50% ECOG 0-2 status Signed informed consent No severe concurrent illness
measurable disease (at least one lesion that can be accurately measured in at least two
dimensions on a CT scan, at least >15 mm in largest diameter

Exclusion Criteria:

- 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%

- Pregnancy

- Somatic or psychiatric disorder making the patient unable to sign an informed consent

- Active or prior documented autoimmune disease requiring systemic treatment.