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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Michigan
Ann Arbor, Michigan, United States
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)
Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2
Time frame: Up to Cycle 17 (cycle length = 21 days)
Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b
Best ORR is defined as the fraction of participants with complete response (CR) or partial response (PR) at any time as determined by the investigator using Lugano 2014 criteria.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
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
...and 7 more locations
Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2
Time frame: 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)
Overall Survival (OS) - Phase 2
Time frame: From the time of first study treatment to death from any cause (up to approximately 4 years)
Percentage of Participants With Adverse Events - Phase 2
Time frame: From the start of treatment until 90 days after the final dose of study treatment