[Translation] A Phase 2/3, multicenter, open-label, randomized, active-controlled study evaluating MK-2140 in combination with standard therapy in subjects with relapsed or refractory diffuse large B-cell lymphoma
主要目的:评价MK-2140与R-GemOx和BR联合使用时的安全性和耐受性,并确定RP2D;(队列A有效性扩展)BICR(盲态独立中心审查)根据Lugano疗效评价标准比较MK-2140联合R-GemOx与R-GemOx的PFS 次要目的:(队列A有效性扩展)比较MK-2140联合R-GemOx与R-GemOx的OS,ORR(BICR)和DOR(BICR)
[Translation] Primary objective: To evaluate the safety and tolerability of MK-2140 in combination with R-GemOx and BR and to determine the RP2D; (Cohort A Efficacy Extension) BICR (Blind Independent Central Review) Compare the PFS of MK-2140 combined with R-GemOx and R-GemOx according to the Lugano efficacy evaluation criteria Secondary objective: (Cohort A Efficacy Extension) Compare the OS, ORR (BICR) and DOR (BICR) of MK-2140 combined with R-GemOx and R-GemOx