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RecruitingLast updated: 19 May 2026

EPCORE™FL-2: This study will assess how safe and effective immunotherapy (called Epcoritamab) is when given in addition to R2 (a combination of Rituximab and Lenalidomide), compared to chemoimmunotherapy, in people with previously untreated follicular lymphomaA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

EPCORE™FL-2

Clinical summary

Summary

Eligible participants will be randomly allocated to one of four treatment arms. Treatment duration is 120 weeks.

Participants may receive R2 (which is an intravenous [IV] infusion of Rituximab and oral capsules of Lenalidomide) alone or in combination with Epcoritamab, which will be given as an injection under the skin. 

Participants may also receive Investigator's choice of chemoimmunotherapy regimen, either G-CHOP/R-CHOP or G-Benda/R-Benda.

Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

 

Conditions

This trial is treating people with follicular lymphoma

Eligibility

Inclusion

  • 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, II, III or IV disease.
  • 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

  • Had major surgery within 4 weeks prior to randomization.
  • Have active cytomegalovirus (CMV) disease.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Genmab

Scientific Title

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

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