NCT06191744 · Genmab
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma
(EPCORE™FL-2)
What this study is about
Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients.
View original scientific description
Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed.
Interventions
DRUG
Epcoritamab
Subcutaneous (SC) Injection
DRUG
Prednisone
Oral Tablet
DRUG
Rituximab
Intravenous (IV) Infusion
DRUG
Lenalidomide
Oral Capsule
DRUG
Doxorubicin
IV Injection
DRUG
Vincristine
IV Injection
DRUG
Cyclophosphamide
IV Injection
DRUG
Obinutuzumab
IV Infusion
DRUG
Bendamustine
IV Infusion
Primary outcome measures
Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
Time frame: Up to 30 Months
CR30 will be determined by positron emission tomography-computerized tomography (cat scan) \[PET-CT\] per Lugano 2014 criteria, as assessed by independent review committee (IRC).
Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)
Time frame: Up to 10 Years
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 le
Where
- Fresno, California
- San Diego, California
- Santa Barbara, California
- Boulder, Colorado
- Newark, Delaware
- Jacksonville, Florida
- Orlando, Florida
- Tampa, Florida
- Coeur d'Alene, Idaho
- Chicago, Illinois
- Decatur, Illinois
- Maywood, Illinois
And 39 more locations — see the full list below.
Collaborators
AbbVie
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations