Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Summary

This phase III trial compares the effects of nivolumab 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 Large B-Cell Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Etoposide Phosphate

Given IV

BIOLOGICAL

Filgrastim

Given SC

PROCEDURE

Lumbar Puncture

Undergo LP

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Prednisolone

Given PO

DRUG

Prednisone

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

BIOLOGICAL

Rituximab

Given IV

BIOLOGICAL

Rituximab and Hyaluronidase Human

Given SC

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Lisa G Roth · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-05

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations