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Clinical Trial 19715

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03671018

Phase: Phase I/II
Principal Investigator: Chavez, Julio

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

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

Summary

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).

Objective

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

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

Bendamustine (); Mosunetuzumab (); Polatuzumab Vedotin (); Rituxan (rituximab); Tocilizumab (); rituximab ()

Inclusion Criteria

ECOG PS of 0, 1, or 2

Patients must have histologically confirmed FL or DLBCL or MCL from the following diagnoses by 2016 WHO classification of lymphoid neoplasms, that have either relapsed or have become refractory to a prior regimen as defined per protocol

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

Additional criteria apply

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

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

Addition exclusions apply

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