Actively Recruiting
Pembrolizumab, Ibrutinib and Rituximab in PCNSL
Led by Dana-Farber Cancer Institute · Updated on 2026-02-20
37
Participants Needed
4
Research Sites
335 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 evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: * Pembrolizumab (MK3475) * Ibrutinib * Rituximab (or biosimilar)
CONDITIONS
Official Title
Pembrolizumab, Ibrutinib and Rituximab in PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign written informed consent
- Willing and able to comply with study visits, treatment, and tests
- At least 18 years old at consent
- Pathologically confirmed primary central nervous system lymphoma with relapsed or refractory disease
- Evidence of disease progression on MRI or cerebrospinal fluid cytology
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy greater than 3 months as judged by investigator
- Stable toxicities from prior therapy at Grade 1 or less
- Able to tolerate lumbar puncture and/or Ommaya taps
- Adequate organ function based on blood tests within 28 days before treatment
- Women of child-bearing potential must have a negative pregnancy test within 72 hours before registration
- Women of child-bearing potential must use highly effective contraception during and for 120 days after study treatment
- Male participants must use contraception or remain abstinent during and for 120 days after study treatment
You will not qualify if you...
- Unable to undergo brain MRI
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Disease progression while on previous ibrutinib or other BTK inhibitors
- Intracranial hemorrhage greater than Grade 2
- Use of warfarin or similar anticoagulants within 7 days before treatment (other anticoagulants allowed)
- Recent arterial thromboembolic event within 3 months
- Active autoimmune disease requiring immunosuppressive treatment or steroids above 10 mg prednisone equivalent
- Systemic autoimmune treatment within past 2 years
- High dose systemic corticosteroids for PCNSL within 2 weeks before registration
- Prior systemic anti-cancer therapy within 4 weeks before dosing
- Major surgery within 2 weeks before treatment or planned within 2 weeks after treatment start
- Unresolved radiation toxicities or recent CNS radiotherapy within 2 weeks
- Live vaccine within 30 days before first dose
- Active additional malignancy requiring treatment within past 3 years
- Severe allergies to study drugs
- History or current pneumonitis requiring steroids
- Active uncontrolled infection or recent serious infection
- Significant cardiovascular disease or uncontrolled hypertension
- Poorly controlled diabetes
- Non-healing wounds or bleeding disorders
- Difficulty swallowing capsules or major gastrointestinal issues
- Use of medications affecting CYP3A4/5 enzyme within 2 weeks before treatment
- Use of enzyme-inducing antiepileptic drugs within 2 weeks before treatment
- Known HIV/AIDS, active Hepatitis B or C, or active tuberculosis
- Immunodeficiency or chronic steroid use above 10 mg prednisone equivalent
- Prior allogeneic stem cell transplant
- Psychiatric or substance abuse issues interfering with study participation
- Pregnant or breastfeeding or planning pregnancy within study duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Columbia University Medical Center
New York, New York, United States, 10032
Withdrawn
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
L
Lakshmi Nayak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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