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 (EPCORE* FL-1)

Phase 3

Recruiting

• Conditions: Follicular Lymphoma; lymfoma; 10018865

• Registration Number: NL-OMON55930
• Lead Sponsor: AbbVie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

1. Adult individuals, at least 18 years old.
2. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance
status score 0 - 2.
3. Subject 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
magnetic resonance image (MRI)
4. Subject must have histologically confirmed classic FL (previously Grade 1 to
3a FL) according to the 5th edition of World Health
Organization (WHO) of Haematolymphoid Tumours with no evidence of histologic
transformation to an aggressive lymphoma at most recent representative tumor
biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
5. Subject must have R/R disease after receiving treatment with at least one
prior antilymphoma regimen that contained an antiCD20 monoclonal antibody in
combination with chemotherapy. (Subject who received only prior anti-CD20
monoclonal antibody monotherapy and/or radiation therapy is not eligible.)
6. Subject must be eligible to receive R2 per investigator determination

Exclusion Criteria

1. Subject must not have documented refractoriness to lenalidomide, with
refractoriness defined as:
o Best response to lenalidomide of stable disease or progressive
disease, or
o Progressive disease within 6 months of completion of lenalidomide
therapy
2. Subjects must not have had lenalidomide exposure within 12 months prior to
randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified