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A drug, pembrolizumab, in combination with chemotherapy (chemo), to treat primary central nervous system (CNS) diffuse large B-cell lymphoma (DLBCL)

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18 and older

Phase 1

2 Locations

NCT06475235

Clinical Trial Goal


To find out:
  • The highest dose of pembrolizumab that's safe to give with chemo
  • If the combination of pembrolizumab and chemo is safe and works well to treat primary CNS DLBCL

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have primary CNS DLBCL
  • Do not have DLBCL outside of the CNS
  • Have not been treated with any of the following (your doctor can tell you this):
    • Anti PD-1
    • Anti PD-L1
    • Anti-PD-L2
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Methotrexate is a chemotherapy (chemo) drug that blocks growth of cancer cells.
Pembrolizumab is a checkpoint inhibitor that targets PD-1 on certain cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Temozolomide is an alkylating agent that slows or stops the growth of cancer cells. 

You’ll get treatment in cycles that last 2 weeks. In each cycle, you'll get: 
  • Methotrexate – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Pembrolizumab – Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Rituximab – Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Temozolomide – A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been

You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years. 

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial.

Contacts


Lakshmi Nayak, MD, 617-632-2166, Lakshmi_Nayak@DFCI.HARVARD.EDU

DFCI Clinical Trials Hotline, 877-338-7425

Locations


Brigham and Women's HospitalRECRUITING

Boston, Massachusetts
Lakshmi Nayak, MD, 617-632-2166, Lakshmi_Nayak@DFCI.HARVARD.EDU

Dana Farber Cancer InstituteRECRUITING

Boston, Massachusetts
Lakshmi Nayak, MD, 617-632-2166, Lakshmi_Nayak@DFCI.HARVARD.EDU

ClinicalTrials.gov record


NCT06475235. First posted on 6/26/24

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