Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT06475235
Brief 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.
Study:
NCT06475235
Study Brief:
Protocol Section:
NCT06475235