Primary Objective: To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to progression-free survival (PFS) per Lugano response criteria as assessed by blinded independent central review (BICR). Hypothesis (H1): Zilovertamab vedotin plus R-CHP is superior to R-CHOP with respect to PFS per Lugano response criteria as assessed by BICR. To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to complete response (CR) rate at end of treatment (EoT) per Lugano response criteria as assessed by BICR. Hypothesis (H2): Zilovertamab vedotin plus R-CHP is superior to R-CHOP with respect to confirmed CR rate at EoT per Lugano response criteria as assessed by BICR. Secondary Objectives: To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to overall survival (OS). Hypothesis (H3): Zilovertamab vedotin plus R-CHP is superior to R-CHOP with respect to OS. To evaluate event-free survival (EFS) with zilovertamab vedotin plus R-CHP versus R-CHOP per Lugano response criteria as assessed by BICR. To evaluate the duration of CR of zilovertamab vedotin plus R-CHP versus R-CHOP. To evaluate the safety and tolerability of zilovertamab vedotin plus R-CHP. To evaluate changes from baseline in health-related QoL assessments using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and FACT/GOG-NTX. To evaluate time to deterioration (TTD) in health-related QoL assessments using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and FACT/GOG-NTX.
What is the full name of this clinical trial?
MK2140-010: A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma