Actively Recruiting
Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL
Led by Dana-Farber Cancer Institute · Updated on 2026-02-20
15
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed newly diagnosed primary CNS diffuse large B-cell lymphoma (DLBCL) by brain biopsy, cerebrospinal fluid, or vitreous fluid
- No evidence or history of DLBCL outside the CNS; prior isolated intraocular lymphoma allowed if only local therapy received
- No prior systemic chemotherapy or whole brain radiation therapy for PCNSL
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 70% or higher if related to PCNSL)
- Adequate organ function including specific hematology, renal, hepatic, and coagulation criteria
- Negative HIV serology
- No history of organ transplantation or ongoing immunosuppressant therapy
- Women of child-bearing potential must have a negative pregnancy test within 72 hours before registration
- Women of child-bearing potential must agree to use highly effective contraception during treatment and for 120 days after
- Male participants must agree to use contraception or abstain from penile-vaginal intercourse during treatment and for 120 days after
You will not qualify if you...
- Unable to undergo MRI
- Intraocular PCNSL without brain or spinal cord disease
- Receiving other investigational agents
- History of severe allergic reactions to similar compounds
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Active autoimmune disease requiring immunosuppressives or steroids
- Received live vaccine within 30 days prior to first study drug dose
- Known progressing malignancy or requiring active treatment within past 3 years (exceptions apply)
- History of pneumonitis requiring steroids or current pneumonitis
- Poorly controlled diabetes mellitus (HbA1c >8%)
- Unable to swallow capsules or significant gastrointestinal dysfunction
- Use of enzyme-inducing antiepileptic drugs unless switched 2 weeks prior
- Known active Hepatitis B or C infection
- Known active tuberculosis
- Diagnosis of immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent daily
- Prior allogeneic stem cell transplant
- Large pleural effusions, ascites, or full body edema
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or expecting to conceive or father children during study and 120 days after last dose
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
L
Lakshmi Nayak, MD
CONTACT
D
DFCI Clinical Trials Hotline
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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