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 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 relapsed or refractory (R/R) 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 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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

NCT05409066

Run by

Genmab

People needed

549

Starts

2022-09-20

Expected to finish

2029-12-01

Last updated by the study team

2026-07-08

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
• Participant 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 MRI.
• Histologically confirmed classic follicular lymphoma (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.
• Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
• Eligible to receive R2 per investigator determination.
• Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

You may not qualify if…

• Documented refractoriness to lenalidomide.
• Have lenalidomide exposure within 12 months prior to randomization.

Where it is running

• University of Arkansas for Medical Sciences /ID# 227198 — Little Rock, Arkansas, United States
• Alta Bates Summit Medical Center for Research /ID# 229428 — Berkeley, California, United States
• Beverly Hills Cancer Center /ID# 231535 — Beverly Hills, California, United States
• Long Beach Memorial Medical Ct /ID# 228997 — Long Beach, California, United States
• University of Southern California /ID# 227195 — Los Angeles, California, United States
• Valkyrie Clinical Trials /ID# 268502 — Los Angeles, California, United States
• Duplicate_Emory University /ID# 227299 — Atlanta, Georgia, United States
• Hawaii Cancer Care - Waterfront Plaza /ID# 262448 — Honolulu, Hawaii, United States
• Northwestern University Feinberg School of Medicine /ID# 227248 — Chicago, Illinois, United States
• Goshen Center for Cancer Care /ID# 227189 — Goshen, Indiana, United States
• Community Health Network, Inc. /ID# 259756 — Indianapolis, Indiana, United States
• Our Lady Of The Lake Regional Medical Center /ID# 251393 — Baton Rouge, Louisiana, United States
• University of Maryland, Baltimore /ID# 227191 — Baltimore, Maryland, United States
• Massachusetts General Hospital /ID# 245233 — Boston, Massachusetts, United States
• UMass Memorial Medical Center /ID# 227323 — Worcester, Massachusetts, United States
• Henry Ford Hospital /ID# 227250 — Detroit, Michigan, United States
• St. Luke's Hospital - Chesterfield /ID# 247817 — Chesterfield, Missouri, United States
• Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220 — Billings, Montana, United States
• Morristown Medical Center /ID# 231427 — Morristown, New Jersey, United States
• Roswell Park Cancer Institute /ID# 239128 — Buffalo, New York, United States
• NYU Langone Hospital - Long Island /ID# 253343 — Mineola, New York, United States
• NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322 — New York, New York, United States
• Icahn School of Medicine at Mount Sinai /ID# 227181 — New York, New York, United States
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193 — New York, New York, United States
• The University of Arizona Cancer Center - North Campus /ID# 228862 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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