This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma \[NHL\]).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)
Participants will receive SC mosunetuzumab for up to 34 cycles
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Progression-free survival (PFS) rate at 24 months after the first study treatment (Cohorts A1, A2, and B)
Time frame: From the first study treatment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by the investigator according to Lugano Criteria 2014 (minimum 2 years)
Objective response rate (ORR), defined as the proportion of participants with a complete metabolic response (CMR) or partial response (PR), as determined by the investigator according to the Lugano Criteria 2014 (Cohorts C, D, and E)
Time frame: Cycles 4, 8, 12 and 17 (cycle length=21 days)
Overall survival (OS) (all cohorts)
Time frame: From first study treatment to death from any cause (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)
ORR, defined as the proportion pf participants with a CMR or PR, as determined by the investigator according to the Lugano Criteria 2014 (Cohorts A1, A2, and B)
Time frame: Cycles 4, 8, 12 and 17 (cycle length=21 days)
Time to response (TTR) (all cohorts)
Time frame: From first study treatment to the first occurrence of a documented objective response observed for patients who achieved a CMR or PR (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)
Duration of response (DOR) (all cohorts)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)
DOR for participants with best response of CMR (all cohorts)
Time frame: From documentation of CMR to the time of progression or death, whichever occurs first (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Infirmary Cancer Care
Mobile, Alabama, United States
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, United States
...and 29 more locations
Duration of complete response (DoCR) (all cohorts)
Time frame: From documentation of CMR to the time of progression or death, whichever occurs first (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)
Time to next treatment (TTNT) (all cohorts)
Time frame: From first study treatment to the start of new anti-lymphoma therapy (NALT) or death (minimum 2 years for Cohorts A1-C or 1 year for Cohorts D and E)
PFS (all cohorts)
Time frame: From first study treatment to first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by investigator according to Lugano Criteria 2014 (min. 2 years for Cohorts A1 - C or 1 year for Cohorts D, E)
Percentage of participants with adverse events (AEs) (all cohorts)
Time frame: Minimum 2 years for Cohorts A-C or 1 year for Cohorts D and E
Serum concentration of mosunetuzumab (all cohorts)
Time frame: Cycle 1 Days 1,2,8,15; thereafter Day 1 of Cycles 2,3,4,6,8,12,16 (cycle length = 21 days)