Go back to trials list
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
Description
Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 1080 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also recei
Trial Eligibility
Inclusion 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 the 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 positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and * \>=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 chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\]. * Have laboratory values meeting the criteria in the protocol. Exclusion Criteria: * Had major surgery within 4 weeks prior to randomization. * Have active cytomegalovirus (CMV) disease.
Study Info
Organization
Genmab
Primary Outcome
Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
Interventions
Locations Recruiting
Rocky Mountain Cancer Centers - Boulder /ID# 261203
United States, Colorado, Boulder
Christiana Care Health Service /ID# 261207
United States, Delaware, Newark
Cancer Specialists of North Florida /ID# 262445
United States, Florida, Jacksonville
Advent Health /ID# 261578
United States, Florida, Orlando
Orlando Health Cancer Institute /ID# 260983
United States, Florida, Orlando
Interested in joining this trial?
Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.
Get the latest thought leadership on your Lymphoma delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.