This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
237
Participants will receive IV mosunetuzumab as defined by the study protocol
Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
Participants will receive oral lenalidomide as defined by the study protocol
Participants will receive SC mosunetuzumab as defined by the study protocol
City of Hope National Medical Center
Duarte, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Norton Cancer Institute - St. Matthews
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 2 Days 1-28 (cycle length = 28 days)
Percentage of Participants with Adverse Events
Time frame: From baseline to 90 days after the last dose of study drug
Cumulative Area under the Curve over Cycles 1-3 (AUC1-3) of Mosunetuzumab
Time frame: Day 1 - Day 78
Serum Trough Concentration at Steady State Approximated by Cycle 4 (Ctrough, c4) of Mosunetuzumab
Time frame: Day 106
Overall Response Rate (ORR) as Determined by the Independent Review Committee (IRC)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
Complete Response Rate (CRR) as determined by the investigator (non-randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
CRR as determined by Independent Review Committee (IRC) (randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
Objective Response Rate (ORR) as determined by the investigator (non-randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
ORR as determined by IRC (randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
Duration of Response (DOR) as determined by the investigator (non-randomized stage)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
DOR as determined by IRC (randomized stage)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
Duration of Complete Reponse (DOCR) as determined by the investigator (non-randomized stage)
Time frame: From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
DOCR as determined by IRC (randomized stage)
Time frame: From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
Percentage of Participants with AEs (Arms A and B)
Time frame: From baseline to 90 days after the last dose of study drug
Minimum Serum Concentration (Cmin) of Mosunetuzumab
Time frame: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
Maximum Serum Concentration (Cmax) of Mosunetuzumab
Time frame: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
Cumulative AUC Over Cycles 1-2 (AUCc1-2) of Mosunetuzumab (Arms A and B)
Time frame: Day 1 - Day 50
Serum Trough Concentration in Cycle 2 (Ctrough, c2) of Mosunetuzumab (Arms A and B)
Time frame: Day 50
AUC at Steady State (AUCss) (Arms A and B)
Time frame: Cycle 4 (cycle length = 28 days)
Percentage of Participants with ADAs to Mosunetuzumab
Time frame: At pre-defined intervals from baseline through follow-up (2 years after last treatment)
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Duke University Medical Center
Durham, North Carolina, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, United States
Rhode Island Hematology/Oncology Program
Woonsocket, Rhode Island, United States
...and 16 more locations