OncoMatch/Clinical Trials/NCT06475235
Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL
Is NCT06475235 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Pembrolizumab and Methotrexate for lymphoma.
Treatment: Pembrolizumab · Methotrexate · Temozolomide · Rituximab — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Primary Central Nervous System Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemotherapy
Participants must not have received any systemic chemotherapy or whole brain radiation therapy directed to PCNSL.
Cannot have received: radiation therapy
Participants must not have received any systemic chemotherapy or whole brain radiation therapy directed to PCNSL.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Cannot have received: anti-PD-L1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Cannot have received: anti-PD-L2 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Cannot have received: checkpoint inhibitor
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1000/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)
Kidney function
Creatinine ≤1.5 x ULN OR measured or calculated creatinine clearance ≥40 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 x ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Participants must have adequate organ function as defined below.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify