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)

Brief description of study

This is a Phase 3 study testing whether the study medicine epcoritamab (an IgG1-bispecific antibody) in combination with other medicines called Rituximab (monoclonal antibody) and Lenalidomide (immunomodulant drug) can work better compared to standard chemotherapy medicines in patients with Follicular Lymphoma (FL) who have not received any previous treatment.

Patients will be divided into four treatment groups. Patients in the first group will receive Epcoritamab in combination with rituximab and lenalidomide. These patients will continue to receive Epcoritamab medicine as a maintenance treatment, meaning a therapy to delay the recurrence of cancer. Patients in the second group will receive Epcoritamab together with rituximab and lenalidomide. Patients in the third group will receive Chemotherapy medicine chosen by the study doctor, and patients in the fourth group will receive lenalidomide + rituximab.

All patients will have special scans taken to see how these medicines are changing their tumor size and helping them stay cancer-free for a longer time compared to standard chemotherapy medicines. The study team will take patients’ blood samples to see how their bodies handle the medicines. Patient’s tumor samples will be taken to learn more about how the medicine works on the tumor. The study team will closely watch all patients for side effects and followed up after treatment.


Clinical Study Identifier: s24-00630
ClinicalTrials.gov Identifier: NCT06191744
Principal Investigator: Catherine M Diefenbach.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Yovanna Giovanis, John P Leonard, Kathryn Dowling, Victoria Hohmann, Kenneth B Hymes, Adam Kittai, Katharine Caceres, Oscar B Lahoud, Danny Perlaza, Amy L Sun, Samuel Yamshon, Megan C Bates, Stephanie M Erichsen, Orel Agami, Tibor Moskovits, Ellaine R Yap, Thaleshravi Prashad, Michael L. Grossbard, Marc Justin Braunstein, Peter Martin, Ariel Karwat, Bruce G Raphael, Marc Schwartz, Connie Li, Megan M. Bulva.


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