NCT07082868

Brief Summary

The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
27mo left

Started Aug 2025

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Aug 2025Aug 2028

First Submitted

Initial submission to the registry

July 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

August 13, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

July 17, 2025

Last Update Submit

May 5, 2026

Conditions

Primary Central Nervous System Lymphoma (PCNSL)Primary Central Nervous System LymphomaRelapsed Primary Central Nervous System LymphomaRefractory Primary Central Nervous System LymphomaCentral Nervous System LymphomaSecondary Central Nervous System LymphomaSecondary Central Nervous System Lymphoma (SCNSL)

Keywords

Primary Central Nervous System LymphomaPCNSLRelapsed Primary Central Nervous LymphomaRefractory Primary Central Nervous LymphomaCentral Nervous System LymphomaSecondary Central Nervous System LymphomaSCNSLepcoritamabibrutinib25-032Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Number of dose limiting toxicities/DLTs

    Cohort A - To determine the safety and tolerability of epcoritamab in combination with ibrutinib in CNS lymphoma patients

    8 weeks

Study Arms (3)

Cohort A

EXPERIMENTAL

Relapsed or refractory PCNSL (n=6)

Drug: ibrutinibDrug: Epcoritamab

Cohort B1

EXPERIMENTAL

Relapsed or refractory PCNSL (n=10)

Drug: ibrutinibDrug: Epcoritamab

Cohort B2

EXPERIMENTAL

Relapsed or refractory PCNSL (n=10)

Drug: ibrutinibDrug: Epcoritamab

Interventions

ibrutinibDRUG

Ibrutinib should be self-administered daily by the participant and should be taken at approximately the same time each day

Cohort ACohort B1Cohort B2
EpcoritamabDRUG

Epcoritamab will be administered at the study site clinic, as a SC injection

Cohort ACohort B1Cohort B2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>/= 18 years of age on the day of consenting to the study.
  • Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)
  • Participants must have an ECOG performance status of 0, 1, or 2.
  • Participants must have adequate bone marrow and organ function shown by:
  • Absolute neutrophil count (ANC) ≥ 1 x 109/L
  • Platelets ≥ 75 x 109/L and no platelet transfusion within the past 21 days prior to study consent
  • Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 21 days prior to study consent
  • International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal (unless receiving anticoagulation)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
  • Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.
  • Creatinine clearance (CLCr) ≥ 30 ml/min (based on the following formular Creatinine clearance= ((140-age)\*wt)/(creatinine\*72); multiply by 0.85 for women)
  • Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose
  • Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry. See section on Pregnancy and Reproduction.
  • Patients must be able to tolerate MRI/CT scans.
  • Due to the nature of this disease, we will allow patients with impaired decision-making ability to enroll into all cohorts.

You may not qualify if:

  • Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.
  • Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded
  • Patient is concurrently using other approved or investigational antineoplastic agents.
  • Patient has an active concurrent malignancy requiring active therapy
  • Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.
  • Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.
  • Patient requires more than 8 mg of dexamethasone daily or the equivalent
  • Patient is using warfarin or any other warfarin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed. Patients with congenital bleeding diathesis are excluded.
  • Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit for at least 3 days prior to Cycle 1 Day 1
  • Patient is taking a drug known to be a moderate or strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least 5 half-lives or at least two weeks, whichever is shorter, prior to starting the study drug.
  • Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of \> 5 mg/day of prednisone or the equivalent (for more than 12 months). Participants must be off of immunosuppressant therapy for at least 28 days prior to the first dose of the study drug.
  • Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening
  • Patient has an ejection fraction of \<50%
  • Patient has a known bleeding diathesis (e.g. von Willebrand's disease) or hemophilia.
  • Patient is documented to have human immunodeficiency virus (HIV) infection.
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Links

MeSH Terms

Interventions

ibrutinib

Study Officials

  • Christian Grommes, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Grommes, MD

CONTACT

212-610-0344grommesc@mskcc.org

Lauren Schaff, MD

CONTACT

212-610-0485schaffl@mskcc.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 24, 2025

Study Start

August 13, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(8)