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No longer recruiting (closed or complete)Last updated: 18 February 2025

EPCORE FL-1: This study will assess how safe and effective immunotherapy (called Epcoritamab) is when given in addition to the existing combination treatment of Rituximab and Lenalidomide (also called R2) in treating people with relapsed or refractory follicular lymphomaA Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

EPCORE FL-1

Clinical summary

Summary

Epcoritamab is an investigational immunotherapy drug being developed for the treatment of follicular lymphoma. In this study, participants will be randomly allocated to one of three treatment arms. Around 500 adult participants will be enrolled in approximately 300 sites across the world. Treatment cycles are 28 days in length.

In Experimental Arm A, participants will receive Epcoritamab at dose level A, which will be given as an injection under the skin, in combination oral Lenalidomide and an IV infusion of Rituximab for 12 cycles. 

In Experimental Arm B, participants will receive Epcoritamab at dose level B, which will be given as an injection under the skin, in combination with oral Lenalidomide and an IV infusion as Rituximab for 12 cycles. Enrollment for this arm has now closed.

In the Active Comparator Arm, participants will receive oral Lenalidomide and an IV infusion of Rituximab for 12 cycles.

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

Conditions

This trial is treating people with relapsed or refractory follicular lymphoma

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
  • Participant has:

    • Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
    • >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
  • Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
  • Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
  • Eligible to receive R2 per investigator determination.
  • Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion

  • Documented refractoriness to lenalidomide.
  • Have lenalidomide exposure within 12 months prior to randomization.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • 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.

Participating hospitals

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More information

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, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma

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