RecruitingPhase 1NCT06475235

Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

A Pilot Study of Pembrolizumab in Combination With Chemotherapy in Newly Diagnosed Primary Central Nervous System Lymphoma


Sponsor

Dana-Farber Cancer Institute

Enrollment

15 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects. This research study involves a combination of the below drugs: * Pembrolizumab (a type of monoclonal antibody) * Methotrexate (a type of anti-metabolite) * Temozolomide (a type of alkylating agent) * Rituximab (a type of antibody)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of pembrolizumab (immunotherapy) and chemotherapy as initial treatment for primary central nervous system (CNS) lymphoma — a type of lymphoma (blood cancer) that starts in the brain or spinal cord. Currently, treatment options are limited, and researchers want to see if adding immunotherapy to existing chemotherapy improves outcomes. **You may be eligible if...** - You are 18 years old or older - You have been newly diagnosed with primary CNS diffuse large B-cell lymphoma (confirmed by brain biopsy, spinal fluid, or eye fluid) - You have not yet received any chemotherapy or whole-brain radiation for this diagnosis - You are generally functional (not severely debilitated) - Your blood counts, kidney, and liver functions are adequate **You may NOT be eligible if...** - You cannot undergo MRI scans - You have active autoimmune disease requiring immune-suppressing treatment - You have previously received immunotherapy drugs targeting PD-1 or PD-L1 - You have HIV or a history of organ transplant - You have active or poorly controlled diabetes (HbA1c > 8%) - 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.

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Interventions

DRUGPembrolizumab

Humanized immunoglobin G4 monoclonal antibody, 4 mL vials, via intravenous infusion (into the vein) per protocol.

DRUGMethotrexate

Anti-metabolite, 50 mL vials, via intravenous infusion per protocol.

DRUGTemozolomide

Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsules, taken orally per protocol.

DRUGRituximab

Anti-CD20 antibody, 10 or 50 mL single-use vials, via intravenous infusion per standard of care.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06475235


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