Featured Trial

A Phase 3, Multicenter, Randomized, Open‑Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma

Study Identifier
M22-003
CT.gov Identifier
NCT06191744
EudraCT Identifier
Not available
EUCTIS ID
2023-506906-38-00
For general inquiries, please contact

844-663-3742 or [email protected]

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Study Details

The EPCORE FL-2 study is for adults with advanced, previously untreated follicular lymphoma (FL). FL is a common type of B-cell non-Hodgkin lymphoma, a slow-growing blood cancer that tends to appear in the lymph nodes, bone marrow, and other organs. While FL is currently considered incurable, treatment aims to improve outcomes for these patients.

This study evaluates the safety and effectiveness of the investigational drug epcoritamab (an antibody that helps the body’s T-cells identify and destroy CD20-expressing B-cells and tumor cells) in combination with lenalidomide (which activates T-cells and natural killer cells) and rituximab (another antibody that works in tandem with epcoritamab) compared to chemoimmunotherapy.

Medical Condition
  • Blood Cancer - Follicular Lymphoma (FL)
    • Study Drug
  • Epcoritamab
  • Prednisone
  • Rituximab
  • Lenalidomide
  • Doxorubicin
  • Vincristine
  • Cyclophosphamide
  • Obinutuzumab
  • Bendamustine
    • Phase
    Phase 3
    Estimated Enrollment
    1095 patients

    Participating in our Clinical Trials

    If you become a participant in this study, you will be randomized into one of four groups to compare the investigational drug in combination with a chemotherapy-free regimen compared to standard-of-care chemoimmunotherapy. The investigational drug will be given as a subcutaneous injection (under the skin). One standard-of-care drug will be given through an intravenous infusion (delivered through a tiny tube into the vein) and another standard-of-care drug as a capsule or tablet that will be taken by mouth. Some participants will be given the study doctor’s choice of standard-of-care chemoimmunotherapy; the drugs in these regimens are administered as intravenous infusions or injections, with the exception of prednisone, which is taken by mouth. Some participants will be given a standard-of-care chemotherapy-free combination of an intravenous drug and capsule or table that will be taken by mouth.

    The study treatment period may last up to 2.5 years, with additional follow-up visits. The total study duration will depend on which study treatment group the participant is in and their response to the study drugs.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    18+ years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be at least 18 years old
    • Have a diagnosis of follicular lymphoma at Ann Arbor Stage III or IV (or Stage II with tumor diameter of ≥ 7 cm)

    Participants must not:

    • Have received prior therapy for your follicular lymphoma
    • Have ever had a more aggressive lymphoma or your disease has changed into a more aggressive form
    • Have a clinically significant cardiovascular disease

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of follicular lymphoma (FL). * Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours. * Are willing and able to comply with procedures required in the protocol. * Must have stage, III, IV or II with bulky disease \>= 7cm). * Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria. * Has one or more target lesions: * A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and * \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\]. * Have laboratory values meeting the criteria in the protocol.
    Exclusion Criteria:
    * Had major surgery within 4 weeks prior to randomization. * Have active cytomegalovirus (CMV) disease.

    Study Locations

    Location
    Status
    Location
    UCSF Fresno /ID# 264712
    Fresno, California, United States, 93701-2302
    Status
    Recruiting
    Location
    Scripps Mercy Hospital /ID# 265393
    San Diego, California, United States, 92103
    Status
    Recruiting
    Location
    Sansum Clinic Research /ID# 261596
    Santa Barbara, California, United States, 93105
    Status
    Recruiting
    Location
    Rocky Mountain Cancer Centers - Boulder /ID# 261203
    Boulder, Colorado, United States, 80303
    Status
    Recruiting
    Location
    Christiana Care Health Service /ID# 261207
    Newark, Delaware, United States, 19713
    Status
    Recruiting
    Location
    Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
    Jacksonville, Florida, United States, 32256
    Status
    Recruiting
    Showing {first} - {last} of {total} Results

    EPCO-AA-0127_RM Version 1.0 Nov2025