A Phase 2 Study of Mosunetuzumab With Polatuzumab Vedotin in Patients With Relapsed/Refractory Follicular Lymphoma
City of Hope Medical Center
Summary
This phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma.
Description
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of mosunetuzumab plus polatuzumab vedotin in patients with relapsed/refractory (R/R) follicular lymphoma (FL). (Safety lead-in) II. Estimate the complete response (CR) rate to mosunetuzumab plus polatuzumab vedotin in R/R FL patients. (Phase II) SECONDARY OBJECTIVES: I. Estimate the overall response rate (ORR), time to first CR, time to best response, duration of response (DOR), duration of response among CR (DORC), progression-free survival (PFS), overall survival (OS), and quality of life (QOL) in R/R FL patients treated with mos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed diagnosis of follicular lymphoma grade…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT or PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalMosunetuzumab
Given SC
- DrugPolatuzumab Vedotin
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuestionnaire Administration
Locations (2)
- City of Hope Medical CenterDuarte, California
- City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California