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A Phase 3, Multicenter, Randomized, Open-Label Trial of Epcoritamab in Combination with R-CHOP compared to R-CHOP in Subjects with High-Risk Diffuse Large B-Cell Lymphoma

The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong PFS compared with 6 cycles of standard R-CHOP followed by 2 cycles of rituximab (R-CHOP) in subjects with newly diagnosed DLBCL with an IPI of 3-5. The first secondary objective is to evaluate and compare PFS between the two treatment arms in subjects with newly diagnosed DLBCL with an IPI of 2-5 (i.e., all-randomized subjects). The other secondary objectives are to evaluate and compare each key secondary endpoint for both the subset of subjects with an IPI of 3-5 and all randomized subjects per the hierarchical order specified in Section 7.7.

The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong PFS compared with 6 cycles of standard R-CHOP followed by 2 cycles of rituximab (R-CHOP) in subjects with newly diagnosed DLBCL with an IPI of 3-5. The first secondary objective is to evaluate and compare PFS between the two treatment arms in subjects with newly diagnosed DLBCL with an IPI of 2-5 (i.e., all-randomized subjects). The other secondary objectives are to evaluate and compare each key secondary endpoint for both the subset of subjects with an IPI of 3-5 and all randomized subjects per the hierarchical order specified in Section 7.7.