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

What this study is about

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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 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 receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Who can join (things the study team will check)

✅ 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 the protocol.
• Must have stage, III, IV or II with bulky disease >= 7cm).
• 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.

🚫 You may not be able to join if…

• Had major surgery within 4 weeks prior to randomization.
• Have active cytomegalovirus (CMV) disease.

Where this trial is running

• UCSF Fresno /ID# 264712, Fresno, California, United States
• Scripps Mercy Hospital /ID# 265393, San Diego, California, United States
• Sansum Clinic Research /ID# 261596, Santa Barbara, California, United States
• Rocky Mountain Cancer Centers - Boulder /ID# 261203, Boulder, Colorado, United States
• Christiana Care Health Service /ID# 261207, Newark, Delaware, United States
• Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445, Jacksonville, Florida, United States
• Advent Health /ID# 261578, Orlando, Florida, United States
• Orlando Health Cancer Institute /ID# 260983, Orlando, Florida, United States
• Moffitt Cancer Center /ID# 259487, Tampa, Florida, United States
• Beacon Cancer Care - Coeur d'Alene /ID# 260670, Coeur d'Alene, Idaho, United States
• Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814, Chicago, Illinois, United States
• Cancer Care Specialists Of Central Illinois /ID# 272464, Decatur, Illinois, United States

+ 254 more sites.

Who to contact

ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06191744.