MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma
SWOG Cancer Research Network
Summary
This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.
Description
PRIMARY OBJECTIVES: I. To compare complete response (CR) rates in participants with relapsed/refractory marginal zone lymphoma randomized to mosunetuzumab subcutaneously (SQ) with or without zanubrutinib (Arm 2 versus Arm 1). II. To compare CR rates in participants with relapsed/refractory marginal zone lymphoma randomized to mosunetuzumab SQ with or without polatuzumab vedotin (Arm 3 versus Arm 1). SECONDARY OBJECTIVES: I. To compare progression-free survival (PFS) between: Ia. Participants randomized to mosunetuzumab SQ with or without zanubrutinib (Arm 2 versus Arm 1); Ib. Participants…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically diagnosed CD20+ marginal zone lymphoma (MZL) as per World Health Organization (WHO) criteria including splenic, nodal, and extranodal subtypes, but excluding gastrointestinal-only marginal zone lymphoma (MZL) with disease assessments that can only be evaluated through endoscopic methods and cutaneous-only MZL. * NOTE: A repeat biopsy to confirm MZL diagnosis is NOT required at time of relapse unless: * The participant has received prior CD3/CD20 bispecific antibody, then a repeat biopsy to document continued CD20+ MZL disease…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo CT scan
- BiologicalMosunetuzumab
Given SC
- DrugPolatuzumab Vedotin
Given IV
- ProcedurePositron Emission Tomography
Undergo PET scan
- OtherSurvey Administration
Ancillary studies
- DrugZanubrutinib
Given PO
Locations (14)
- Helen F Graham Cancer CenterNewark, Delaware
- Medical Oncology Hematology Consultants PANewark, Delaware
- Kootenai Health - Coeur d'AleneCoeur d'Alene, Idaho
- Kootenai Clinic Cancer Services - Post FallsPost Falls, Idaho
- Kootenai Clinic Cancer Services - SandpointSandpoint, Idaho
- Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, Michigan