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Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma

NCT03677154

CompletedPhase 1, Phase 2

Sponsor: Hoffmann-La Roche

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Mosunetuzumab Intravenous (IV), Mosunetuzumab Subcutaneous (SC), Polatuzumab Vedotin, Tocilizumab

Countries: United States, Israel, Poland, South Korea, Spain, Taiwan

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria for All Cohorts

* At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter
* Adequate hematologic function
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; with the exception of South Korea, where participants 80 years or older with ECOG \>/= 2 will not be eligible

Inclusion Criteria Specific to Cohort A

Participants in Cohort A must also meet the following criteria for study entry:

* Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen
* One prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL
* Best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria

Inclusion Criteria Specific to Cohorts B and C

Participants in Cohorts B and C must also meet the following criteria for study entry:

* Previously untreated, histologically confirmed, DLBCL according to WHO 2016 classification
* Age \>/= 80 years, or
* Age 65-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least two activity of daily living (ADL) components as defined in the protocol; impairment in at least two instrumental ADL components as defined in the protocol; cumulative illness rating scale - geriactic (CIRS-G) score of at least one cormorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \>/= 8 comorbidities; impairment in cardiac function, renal function, liver function, or other comorbidities such that the participant is unfit for full-dose immunochemotherapy, such as rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
* Participants with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment during the screening phase (not more than 100 mg/day up to 7 days prior to Cycle 1 Day 1) results in an improvement of ECOG performance status to \</= 2 prior to enrollment

Exclusion Criteria for All Cohorts

Participants who meet any of the following criteria will be excluded from study entry:

* Transformed lymphoma
* CNS lymphoma
* Prior treatment with mosunetuzumab
* Prior stem cell transplant (autologous and allogeneic)
* History of confirmed progressive multifocal leukoencephalopathy (PML)
* Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1
* Prior solid organ transplantation
* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Clinically significant history of liver disease
* Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1)
* Significant cardiovascular disease

Exclusion Criteria Specific to Cohort A

Participants in Cohort A who meet the following criteria will be excluded from study entry:

\- Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to C1D1

Exclusion Criterion Specific to Cohorts B and C

Participants in Cohorts B and C who meet the following criterion will be excluded from study entry:

\- Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy

Exclusion Criteria Specific to Cohort C

Participants in Cohort C who meet the following criteria will be excluded from study entry:

\- Current Grade \>1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease

Locations (32)

Birmingham, Alabama, United States
Santa Monica, California, United States
Fort Wayne, Indiana, United States
Baltimore, Maryland, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Beersheba, Israel
Haifa, Israel
Haifa, Israel
Jerusalem, Israel
Jerusalem, Israel
Kfar Saba, Israel
Ramat Gan, Israel
Gdansk, Poland
Krakow, Poland
Lublin, Poland
Opole, Poland
Busan, South Korea
Daegu, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seville, Sevilla, Spain
Barcelona, Spain
Barcelona, Spain
Cáceres, Spain
Madrid, Spain
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