NCT06475235

Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is an open label, pilot trial of Pembrolizumab in combination with chemotherapy in participants with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL). The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for Primary Central Nervous System Lymphoma (PCNSL) but it has been approved for other uses. The FDA has approved Rituximab for PCNSL. The FDA has not approved Temozolomide for PCNSL but it has been approved for other uses. The FDA has not approved Methotrexate for PCNSL but it has been approved for other uses. The research study procedures include screening for eligibility, blood and urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, testicular ultrasounds, electrocardiograms (ECG), and eye exams. It is expected that about 15 people will take part in this research study. Merck \& Co. is supporting this research study by providing the study drug pembrolizumab.

Conditions

• Lymphoma
• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Humanized immunoglobin G4 monoclonal antibody, 4 mL vials, via intravenous infusion (into the vein) per protocol.
DRUG	Methotrexate	Anti-metabolite, 50 mL vials, via intravenous infusion per protocol.
DRUG	Temozolomide	Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsules, taken orally per protocol.
DRUG	Rituximab	Anti-CD20 antibody, 10 or 50 mL single-use vials, via intravenous infusion per standard of care.

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-12-30
• Completion: 2027-06-30
• First posted: 2024-06-26
• Last updated: 2026-02-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study