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Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

NCT06475235 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-20

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Lakshmi Nayak, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-18
Primary Completion
2026-12-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475235 on ClinicalTrials.gov