Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06475235
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lymphoma
  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Humanized immunoglobin G4 monoclonal antibody, 4 mL vials, via intravenous infusion (into the vein) per protocol.
  • Methotrexate — DRUG
    Anti-metabolite, 50 mL vials, via intravenous infusion per protocol.
  • Temozolomide — DRUG
    Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsules, taken orally per protocol.
  • Rituximab — DRUG
    Anti-CD20 antibody, 10 or 50 mL single-use vials, via intravenous infusion per standard of care.

Study Details

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)

Key Dates

Start date
Oct 18, 2024
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Treatment:
    Participants will be enrolled and will complete procedures as follows, starting at Dose Level 0 for Methotrexate and Temozolomide: * Baseline visit with assessments and imaging. * Imaging on cycles 3 and 6 only. * Cycles 1 through 3: ---Days 3 and 10 of 14 day cycle: Predetermined dose of Rituximab 1x daily. * Cycles 1, 3, 5, and 7: ---Days 7 through 11 of 14 day cycle: Predetermined dose of Temozolomide 1x daily. * Cycles 1 through 8: ---Day 1 of 14 day cycle: Predetermined dose of Methotrexate 1x daily. * Cycles 1, 4, 7 * Day 10 of 14 day cycle: Predetermined dose of Pembrolizumab 1x daily. Treatment will de-escalate per protocol if greater than or equal to 2 out of 6 participants experience a dose-limiting toxicity.
  • Experimental: Consolidation Treatment:
    4-8 weeks after the completion of Induction Cycle 8, the study doctor will determine if it is appropriate to move on to consolidation therapy and participants will complete: * Imaging every other cycle. * Cycles 1 through 15: * Day 1 of 42 day cycle: Lumbar puncture * Day 1 of 42 day cycle: Predetermined dose of Pembrolizumab 1x daily. * End of treatment visit with lumbar puncture and imaging. * Follow up

Primary Outcome Measure

Number of Patients Experienced Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Lakshmi Nayak, MD
[email protected]
617-632-2166
Lakshmi Nayak, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Lakshmi Nayak, MD
[email protected]
(617) 632-2166
Lakshmi Nayak, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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