A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

Description

Primary Objectives:

To determine the safety and efficacy of mosunetuzumab in combination with zanubrutinib as determined by best complete response (CR) rate of combination treatment for patients with relapsed or refractory marginal zone lymphoma (MZL).

Secondary Objectives:

To determine best overall response rate (ORR), duration of response (DOR), time to next treatment, progression-free survival (PFS), overall survival (OS), and evaluation of tolerability of mosunetuzumab and zanubrutinib as treatment for patients with relapsed/refractory MZL.

Exploratory Objective:

To determine the impact of total metabolic tumor volume to ORR, CR rate and survival outcomes

To determine the biomarkers that correlates with response and mechanisms of resistance to mosunetuzumab and zanubrutinib in relapsed/refractory MZL.

To determine the surrogate endpoint for future trials in MZL.