Pembrolizumab, Ibrutinib and Rituximab in PCNSL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04421560
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Primary Central Nervous System Lymphoma
  • Recurrent Cancer
  • Refractory Cancer
  • Relapsed Cancer

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Capsule, taken by mouth daily
  • Pembrolizumab — DRUG
    Given as an intravenous injection through a vein (IV) every 3 weeks
  • Rituximab — DRUG
    Given as infusion into a vein (intravenous, IV)

Study Details

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)

Key Dates

Start date
Aug 1, 2020
Status verified
Feb 2026
Primary completion
Dec 5, 2026
Completion
Jan 5, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Ibrutinib + Rituximab
    Phase 1b Dose escalation will occur using a standard 3+3 dose-escalation approach, beginning at dose level I (560 mg daily) and potentially escalating to dose level 2 (840mg) with rules for escalation and de-escalation. * Ibrutinib: orally 2x daily * Pembrolizumab: 200 mg intravenously every 3 weeks * Rituximab/biosimilar: 375mg/m\^2 intravenously once per week for 4 weeks (4 total doses). Phase 2 Participants will receive Pembrolizumab, Rituximab and Ibrutinib at the pre-determined dosage level established in Phase 1b. * Ibrutinib: orally maximum tolerated dose from phase 1 daily (560 mg or 840mg) * Pembrolizumab: 200 mg intravenously every 3 weeks * Rituximab/biosimilar: 375 mg/m\^2 intravenously once per week for 4 weeks (4 total doses).

Primary Outcome Measure

Progression-free survival rate 6 months (PFS6) [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Ka-Wai Ho, MD
617-667-7000
Dana Farber Cancer InstituteBostonMassachusetts02115
Lakshmi Nayak, MD
[email protected]
617-632-2166
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Christian Grommes, MD

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By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAColumbia University Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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