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

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) - EPCORE™ FL-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000169-34-SE

Enrollment

500

Registered

2022-06-15

Start date

2022-10-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Follicular Lymphoma MedDRA version: 24.0 Level: PT Classification code 10085128 Term: Follicular lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Epcoritamab Product Code: ABBV-GMAB-3013 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Epcoritamab CAS Number: 2134641-34-0 Current Sponsor code: ABBV-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: • 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. ;Primary end point(s): -Disease progression as determined by Lugano criteria (Appendix F) by an IRC -Death ;Timepoint(s) of evaluation of this end point: An interim analysis for both efficacy and futility will occur when 128 PFS events (75% information fraction) are observed in the ITT population. The PFS final analysis will occur after 171 PFS events have accumulated in the ITT population.	—

Measure

Time frame

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: • 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. ;Primary end point(s): -Disease progression as determined by Lugano criteria (Appendix F) by an IRC -Death ;Timepoint(s) of evaluation of this end point: An interim analysis for both efficacy and futility will occur when 128 PFS events (75% information fraction) are observed in the ITT population. The PFS final analysis will occur after 171 PFS events have accumulated in the ITT population.

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Secondary

Measure	Time frame
Secondary end point(s): •Complete Response (CR) during the study, determined by Lugano criteria, as assessed by IRC •Overall survival (OS) •Minimal residual disease (MRD) negativity ;Timepoint(s) of evaluation of this end point: -CR/BOR: Throughout the study. -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. -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 -The OS final analysis will occur after approximately 135 OS events have accumulated in the mITT population.	—

Measure

Time frame

Secondary end point(s): •Complete Response (CR) during the study, determined by Lugano criteria, as assessed by IRC •Overall survival (OS) •Minimal residual disease (MRD) negativity ;Timepoint(s) of evaluation of this end point: -CR/BOR: Throughout the study. -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. -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 -The OS final analysis will occur after approximately 135 OS events have accumulated in the mITT population.

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Puerto Rico, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Trials Helpdesk

AbbVie Ltd.

global-clinical-trials@abbvie.com+441628 561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026