A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT03671018
This study assesses the safety and efficacy of mosunetuzumab (IV/SC) with polatuzumab vedotin in R/R DLBCL, FL, and MCL. Eligible participants must have prior anti-CD20 therapy and measurable disease. Interventions include mosunetuzumab, polatuzumab vedotin, and as needed, tocilizumab and rituximab. Participants must have adequate organ function and meet specific prior treatment criteria.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.
Eligibility Criteria
Inclusion Criteria
- ECOG PS of 0, 1, or 2
- Histologically confirmed FL, DLBCL, or MCL
- Must have received at least one prior systemic treatment regimen containing an anti-CD20-directed therapy for DLBCL or FL
- For MCL, participants must have received at least two prior systemic treatment regiments, which include 1) anti-CD20-directed therapy, 2) BTK inhibitor, and 3) anthracycline or bendamustine
- Relapsed to prior regimen(s) after having a documented history of response (complete response [CR], CR unconfirmed [CRu], or partial response [PR]) of >/= 6 months in duration from completion of regimen(s); or, refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy
- Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
- Adequate hematologic, renal, and hepatic function
Key
Exclusion Criteria
- Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
- Prior treatment with polatuzumab vedotin
- Current > Grade 1 peripheral neuropathy
- Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate (ADC) within 4 weeks before first dose of study treatment
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
- Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
- Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration
- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first study treatment administration
- Prior allogeneic SCT
- Prior solid organ transplantation
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)
- Current or past history of central nervous system (CNS) lymphoma or CNS disease
- History of autoimmune disease
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | 35249 | Birmingham | Alabama |
| City of Hope | 91010 | Duarte | California |
| University of Colorado Hospital - Anschutz Cancer Pavilion | 80045 | Aurora | Colorado |
| University of Miami Miller School of Medicine | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Michigan Hospital | 48109 | Ann Arbor | Michigan |
| Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| New York University Langone Medical Center | 10016 | New York | New York |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| Penn State Milton S. Hershey Medical Center | 17033 | Hershey | Pennsylvania |
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