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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

NCT06188676 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-01-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Research Center for Hematology, Russia

    lead NETWORK

Principal Investigators

  • Elena Parovichnikova, MD,PhD · Nathional Medical Research Center for Hematology Moscow Russia 125167

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2029-04-01
Completion
2029-04-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188676 on ClinicalTrials.gov