A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma
Phase 1
Recruiting
- Conditions
- Follicular Lymphoma
- Interventions
- Registration Number
- NCT04246086
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 237
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized) Mosunetuzumab (IV) Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) Arm A: IV Mosunetuzumab + Len (Randomized) Mosunetuzumab (IV) Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) Arm B: SC Mosunetuzumab + Len (Randomized) Mosunetuzumab (SC) Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized) Tocilizumab Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized) Lenalidomide Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized) Tocilizumab Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles. Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized) Lenalidomide Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles. Arm A: IV Mosunetuzumab + Len (Randomized) Lenalidomide Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward) Arm B: SC Mosunetuzumab + Len (Randomized) Lenalidomide Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
- Primary Outcome Measures
Name Time Method Dose-Limiting Toxicities (DLTs) Cycle 2 Days 1-28 (cycle length = 28 days) Percentage of Participants with Adverse Events 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 Day 1 - Day 78 Serum Trough Concentration at Steady State Approximated by Cycle 4 (Ctrough, c4) of Mosunetuzumab Day 106 Overall Response Rate (ORR) as Determined by the Independent Review Committee (IRC) Up to the end of Cycle 12 (cycle length = 28 days)
- Secondary Outcome Measures
Name Time Method Complete Response Rate (CRR) as determined by the investigator (non-randomized stage) Up to the end of Cycle 12 (cycle length = 28 days) CRR as determined by Independent Review Committee (IRC) (randomized stage) Up to the end of Cycle 12 (cycle length = 28 days) Objective Response Rate (ORR) as determined by the investigator (non-randomized stage) Up to the end of Cycle 12 (cycle length = 28 days) ORR as determined by IRC (randomized stage) Up to the end of Cycle 12 (cycle length = 28 days) Duration of Response (DOR) as determined by the investigator (non-randomized stage) 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) 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) 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) 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) From baseline to 90 days after the last dose of study drug Minimum Serum Concentration (Cmin) of Mosunetuzumab At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment) Maximum Serum Concentration (Cmax) of Mosunetuzumab 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) Day 1 - Day 50 Serum Trough Concentration in Cycle 2 (Ctrough, c2) of Mosunetuzumab (Arms A and B) Day 50 AUC at Steady State (AUCss) (Arms A and B) Cycle 4 (cycle length = 28 days) Percentage of Participants with ADAs to Mosunetuzumab At pre-defined intervals from baseline through follow-up (2 years after last treatment)
Trial Locations
- Locations (32)
Mary Bird Perkins Cancer Ctr
🇺🇸Baton Rouge, Louisiana, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
City of Hope National Medical Center
🇺🇸Duarte, California, 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
Tennessee Oncology;Chattanooga Oncology & Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Tennessee Oncology PLLC - Franklin
🇺🇸Franklin, Tennessee, United States
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