RecruitingPhase 1NCT04609046

Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma

Sponsor

National Cancer Institute (NCI)

Enrollment

47 participants

Start Date

May 24, 2021

Study Type

INTERVENTIONAL

Conditions

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

Summary

This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. 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. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two immune-boosting drugs — lenalidomide and nivolumab — to the standard chemotherapy treatment improves outcomes for people newly diagnosed with primary CNS lymphoma (a rare type of lymphoma that occurs in the brain or spinal fluid). **You may be eligible if...** - You have been newly diagnosed with primary CNS diffuse large B-cell lymphoma, confirmed by brain biopsy, spinal fluid, or eye fluid testing - You have not yet received chemotherapy or radiation for lymphoma - You have not had an organ transplant - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have already been treated with chemotherapy or radiation for lymphoma - You received a stem cell or organ transplant in the past - You have a serious active infection or autoimmune disease that requires systemic treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspirate and biopsy

PROCEDUREComputed Tomography

Undergo CT and PET/CT

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGLenalidomide

Given PO

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGMethotrexate

Given IV or PO

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALRituximab

Given IV

PROCEDUREUltrasound Imaging

Undergo testicular ultrasound

Locations(54)

Cedars Sinai Medical Center

Los Angeles, California, United States

UCSF Medical Center-Parnassus

San Francisco, California, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Iowa Methodist Medical Center