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
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT05315713
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
- Non-Hodgkin Lymphoma, Follicular Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mosunetuzumab SC — DRUGParticipants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)
- Tiragolumab — DRUGParticipants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)
- Atezolizumab — DRUGParticipants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)
- Tocilizumab — OTHERParticipants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Study Details
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.
Key Dates
- Start date
- May 10, 2022
- Status verified
- Sep 2024
- Primary completion
- Jul 19, 2023
- Completion
- Jul 19, 2023
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) TiragolumabParticipants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
- Experimental: Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IVParticipants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days) Note: This arm did not enroll any participants.
Primary Outcome Measure
Percentage of Participants With Adverse Events - Phase 1b [ Time Frame: From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks) ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
| University of Michigan | Ann Arbor | Michigan | 48109 | - |
| Lifespan Cancer Institute | Providence | Rhode Island | 02905 | - |