An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT05315713
Last Updated: 2024-10-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2022-05-10
2023-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Mosunetuzumab SC
Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)
Tiragolumab
Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Note: This arm did not enroll any participants.
Mosunetuzumab SC
Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)
Tiragolumab
Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)
Atezolizumab
Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Interventions
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Mosunetuzumab SC
Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)
Tiragolumab
Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)
Atezolizumab
Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)
Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* Histologically documented FL or DLBCL that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells)
* At least one bi-dimensionally measurable (\> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (\> 1.0 cm) extranodal lesion
* Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can be collected
* Adequate hematologic and organ function
Exclusion Criteria
* Currently eligible for autologous SCT
* Current or past history of CNS lymphoma or leptomeningeal infiltration
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Contraindication to atezolizumab (if applicable) or tocilizumab
* Clinically significant toxicities from prior treatment have not resolved to Grade \</= 1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions defined by the protocol
* Treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol
* Evidence of any significant, concomitant disease as defined by the protocol
* Major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
* Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* History of autoimmune disease with exceptions as defined in the protocol
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
AZ Sint Jan Brugge Oostende AV
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU UCL Namur - Mont-Godinne
Yvoir, , Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Universitaet Duisburg-Essen
Essen, , Germany
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Chelsea
London, , United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, , United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Sutton
Sutton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CO43116
Identifier Type: -
Identifier Source: org_study_id
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