Study Stopped
Study was terminated due to Sponsor decision.
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
A Phase Ib/II Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
1 other identifier
interventional
8
6 countries
17
Brief Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2022
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2023
CompletedResults Posted
Study results publicly available
October 4, 2024
CompletedOctober 4, 2024
September 1, 2024
1.2 years
March 31, 2022
July 16, 2024
September 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Adverse Events - Phase 1b
From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2
Up to Cycle 17 (cycle length = 21 days)
Secondary Outcomes (8)
Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b
Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days)
Serum Concentration of Mosunetuzumab - Phase 1b
Cycle 1 Day 1 - Cycle 8 Day 1 (cycle length = 21 days)
Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b
Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days)
Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b and Phase 2
From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)
Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2
From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)
- +3 more secondary outcomes
Study Arms (2)
Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab
EXPERIMENTALParticipants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
EXPERIMENTALParticipants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days) Note: This arm did not enroll any participants.
Interventions
Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)
Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)
Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Eligibility Criteria
You may qualify if:
- Aged \>/= 18 years
- 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
You may not qualify if:
- Received any of the following treatments prior to study entry: mosunetuzumab or other CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent; allogenic SCT; solid organ transplantation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Lifespan Cancer Institute
Providence, Rhode Island, 02905, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
AZ Sint Jan Brugge Oostende AV
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU UCL Namur - Mont-Godinne
Yvoir, 5530, Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, T2N 4N2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5, Canada
Universitaet Duisburg-Essen
Essen, 45122, Germany
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Chelsea
London, SE3 6JJ, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Sutton
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination led to small numbers of participants for analysis.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 7, 2022
Study Start
May 10, 2022
Primary Completion
July 19, 2023
Study Completion
July 19, 2023
Last Updated
October 4, 2024
Results First Posted
October 4, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).