Phase 2 Study of Epcoritamab for Adults With Follicular Lymphoma Who Did Not Achieve Complete Response After First-Line Chemoimmunotherapy

What this Trial Is About

Researchers are evaluating epcoritamab as a second-line treatment for patients with follicular lymphoma who did not achieve a complete response after initial chemoimmunotherapy. This phase 2, single-arm, open-label trial is studying a bispecific antibody designed to activate the immune system to target cancer cells. The Food and Drug Administration has not approved epcoritamab for follicular lymphoma but has approved it for other conditions. Participants will receive epcoritamab through subcutaneous injections in up to 12 treatment cycles. Early cycles involve more frequent dosing, with injections on days 1, 8, 15, and 22 of a 28-day cycle, which then transitions to less frequent dosing in later cycles. Imaging scans and bone marrow biopsies occur at baseline, after certain cycles, and at the end of treatment. After completing treatment, participants will be monitored every three months for two years or until their disease worsens. During the study, participants will undergo screening visits, imaging tests such as CT, MRI, and PET scans, blood tests, electrocardiograms, and bone marrow biopsies. Questionnaires will also be collected throughout the study. Researchers will assess the complete response rate up to 12 months as the primary outcome and monitor several secondary outcomes including overall response, progression-free survival, and treatment-related toxicities. Follow-up visits will continue for up to five years to observe long-term outcomes and safety.

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy