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An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Mosunetuzumab (Btct4465a) In Combination With Polatuzumab Vedotin In Patients With B-Cell Non-Hodgkin Lymphoma
This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in participants with B-cell non-Hodgkin lymphoma (NHL). It will consist of a dose finding portion and two randomized cohorts for participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Safety Endpoints To evaluate the safety and tolerability of mosunetuzumab plus polatuzumab vedotin in patients with R/R DLBCL or FL, including estimation of the MTD, determination of the RP2D, and characterization of DLTs Efficacy Objective To make a preliminary assessment of the anti-tumor activity of mosunetuzumab plus polatuzumab vedotin Primary Efficacy Endpoints To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with polatuzumab vedotin plus bendamustine and rituximab in patients with R/R DLBCL To evaluate the efficacy of mosunetuzumab plus polatuzumab vedotin compared with physicians choice of rituximab plus chemotherapy (CHOP or CVP) or obinutuzumab plus bendamustine followed by obinutuzumab maintenance in patients with R/R FL