BridgeMD
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
EU CTIS ID: 2023-506906-38-00
What this study is testing
The primary objective of the study is to demonstrate that epcoritamab with R2 followed by epcoritamab maintenance (ER2 + E- Arm A1) will improve CR30 rates and PFS using Lugano criteria by IRC compared to chemoimmunotherapy followed by anti-CD20 maintenance therapy (CIT + maintenance - Arm B) in subjects with previously untreated FL.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 this 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) A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and (b) >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
You likely can't join if
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
See the full eligibility criteria
- 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 this 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) A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and (b) >=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 CIT treatment regimens (Arm B) at the discretion of the Investigator, and R2 (Arm C)
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United States
- Brazil
- Canada
- Puerto Rico
- Japan
- South Africa
- China
- Israel
- Turkey
- Australia
- United Kingdom
- Taiwan
- Korea, Republic of
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United States; Brazil; Canada; Puerto Rico; Japan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.