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Epcoritamab combined with Rituximab and Lenalidomide for treating untreated Follicular Lymphoma

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 (EPCORE™FL-2)

Phase 3 Interventional Genmab · NCT06191744

This study is testing whether a new combination of three treatments can help adults with untreated follicular lymphoma feel better and manage their disease more effectively.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1095 (estimated)
Ages18 Years and up
SexAll
SponsorGenmab Industry-sponsored
Drugs / interventionsrituximab, epcoritamab, obinutuzumab, cyclophosphamide, doxorubicin, prednisone
Locations266 sites (Fresno, California and 265 other locations)
Trial IDNCT06191744 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of epcoritamab when used alongside rituximab and lenalidomide in adults with previously untreated follicular lymphoma. Participants will be divided into five treatment groups, each receiving different combinations of these therapies. The study aims to assess adverse events and changes in disease activity among approximately 1095 participants across 250 global sites. The goal is to determine the potential benefits of this combination therapy for managing follicular lymphoma.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with CD20+ follicular lymphoma requiring systemic treatment.

Not a fit: Patients with early-stage follicular lymphoma or those who have received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with previously untreated follicular lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating follicular lymphoma, indicating potential for success.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Fresno, California and 265 other locations

+216 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Follicular LymphomaNon-Hodgkin's lymphomaLymphomaCancerEpcoritamabRituximabLenalidomideChemoimmunotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.