NCT06911502 – A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination with Rituximab (Golca + R) Vs Investigator’s Choice in Participants with Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)
This Phase III trial (GOLSEEK-4) compares golcadomide plus rituximab against the investigator’s choice of standard treatment in adults with relapsed or refractory follicular lymphoma who have received at least one prior line of therapy. Golcadomide is an oral, first in class CELMoD agent that targets a protein called cereblon, leading to the degradation of two other proteins, Ikaros and Aiolos, which in turn causes direct cancer cell death and boosts immune activity against the lymphoma. Eligible patients have grade 1, 2, or 3A follicular lymphoma with measurable disease. Patients randomized to the golcadomide plus rituximab arm receive golcadomide daily for 14 days of each 28 day cycle alongside rituximab for five cycles, followed by seven cycles of golcadomide alone. Patients are followed for up to five years, with progression free survival as the primary endpoint.