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

Running, not enrolling · Phase 3

Conditions studied: Follicular Lymphoma (FL)

In brief

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.

Key facts

Study ID

NCT06191744

Run by

Genmab

People needed

1095

Starts

2024-02-05

Expected to finish

2037-11-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

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

Where it is running

• 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
• Loyola University /ID# 259462 — Maywood, Illinois, United States
• Illinois Cancer Care, PC /ID# 261526 — Peoria, Illinois, United States
• Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583 — Fort Wayne, Indiana, United States
• University of Iowa Health Care /ID# 262132 — Des Moines, Iowa, United States
• University of Louisville Hospital /ID# 260544 — Louisville, Kentucky, United States
• Norton Cancer Institute - St. Matthews /ID# 261076 — Louisville, Kentucky, United States
• New England Cancer Specialists - Westbrook /ID# 260672 — Westbrook, Maine, United States
• University of Maryland, Baltimore /ID# 259538 — Baltimore, Maryland, United States
• Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476 — Bethesda, Maryland, United States
• St. Luke's Hospital - Chesterfield /ID# 260489 — Chesterfield, Missouri, United States
• Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006 — Billings, Montana, United States
• Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506 — Grand Island, Nebraska, United States
• Nebraska Hematology-Oncology /ID# 269692 — Lincoln, Nebraska, United States
• UCSF Fresno /ID# 264712 — Fresno, California, United States

Full record on ClinicalTrials.gov

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