This study is to find out about the Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma

Phase 1

Conditions: Relapsed/Refractory Follicular Lymphoma
MedDRA version: 24.0Level: PTClassification code 10085128Term: Follicular lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-000169-34-SE

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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) 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, according
to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid
Tumours7
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this randomized Phase 3 study is to evaluate the efficacy, safety, and tolerability of epcoritamab 48 mg in combination with R2 compared to R2 alone in subjects with R/R FL.;Secondary Objective: The secondary objective is as follows:<br>• To evaluate whether epcoritamab 48 mg in combination with R2 compared to R2 alone can improve clinical outcomes as measured by key secondary endpoints (including CR, overall survival [OS], and minimal residual disease [MRD] negativity) in subjects with R/R FL.<br><br>;Primary end point(s): -Disease progression as determined by Lugano criteria (Appendix F) by an IRC<br>-Death<br>;Timepoint(s) of evaluation of this end point: An interim analysis for both efficacy and futility will occur when 128 PFS<br>events (75% information fraction) are observed in the ITT population.<br>The PFS final analysis will occur after 171 PFS events have accumulated<br>in the ITT population.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Complete Response (CR) during the study, determined by Lugano criteria, as assessed by IRC<br>•Overall survival (OS)<br>•Minimal residual disease (MRD) negativity<br>;Timepoint(s) of evaluation of this end point: -CR/BOR: Throughout the study.<br>-MRD: Throughout study till Post-Treatment Follow-up visits which will occur for a period of 5 years after the last subject has been randomized or until discontinuation, whichever comes first. <br>-Survival: Throughout the study until death, withdrawal of the subject, lost to follow up, study discontinuation, or study termination by the Sponsor, whichever comes first<br>-The OS final analysis will occur after approximately 135 OS events have<br>accumulated in the mITT population.<br>

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