Relapsed or refractory follicular lymphoma Cancer Follicular lymphoma
Conditions
Interventions
Participants will be given mosunetuzumab intravenously (IV) in a step-up dosing schedule in 21-day cycles for 8 or 17 cycles depending on tumour response unless objective disease progression is docume
Sponsors
Roche (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of signing Informed Consent Form (ICF) 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 3. Histologically confirmed Grade 1-3a follicular lymphoma who have relapsed after or failed to respond to at least two prior lines of systemic therapy and must have received prior treatment with an anti-CD20-directed therapy and an alkylating agent 4. Participants must have a measurable disease: at least one bi-dimensionally measurable lesion (greater than 1.5 cm in its largest dimension for nodal lesions, or greater than 1.0 cm in its largest dimension for extranodal lesions) 5. Fluorodeoxyglucose (FDG)-avid lymphoma [i.e., positron emission tomography (PET) - positive lymphoma] 6. Adverse events from prior anti-cancer therapy resolved to = Grade 1 (with exceptions of alopecia and anorexia) 7. Residence in the People’s Republic of China
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable) 2. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before the first mosunetuzumab administration 3. Prior treatment with systemic immunotherapeutic agents for which the mechanism of action involves T cells within 12 weeks or five half-lives of the drug, whichever is shorter, before first Mosunetuzumab administration 4. Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents (e.g., immune checkpoint inhibitor therapies) 5. Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first mosunetuzumab administration 6. Treatment with radiotherapy within 2 weeks prior to the first mosunetuzumab administration 7. Autologous stem cell transplant (SCT) within 100 days prior to first mosunetuzumab administration 8. Prior treatment with CAR-T therapy within 30 days before first Mosunetuzumab administration 9. Prior allogeneic SCT 10. Prior solid organ transplantation 11. History of autoimmune disease but participants with a remote history of, or well-controlled autoimmune disease may be eligible to enrol 12. Participants with a history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH) 13. Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) 14. Current or past history of CNS lymphoma 15. Known or suspected chronic active Epstein-Barr Virus infection (CAEBV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serum concentration of mosunetuzumab measured using enzyme-linked immunosorbent assay (ELISA) at multiple timepoints points from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) 2. Area under the curve (AUC) of mosunetuzumab derived from the serum concentration-time profiles from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) 3. Maximum concentration (Cmax) of mosunetuzumab derived from the serum concentration-time profiles from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) 4. Minimum concentration (Cmin) of mosunetuzumab derived from the serum concentration-time profiles from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) 5. Total clearance (CL/F) of mosunetuzumab derived from the serum concentration-time profiles from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) 6. Volume of distribution (Vd) of mosunetuzumab derived from the serum concentration-time profiles from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) 7. Terminal half-life (t1/2) of mosunetuzumab derived from the serum concentration-time profiles from Cycle 1 Day 1 up to =90 days after last study drug administration (up to approximately 40 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with adverse events and severity per National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0) from screening up to approximately 40 months 2. Percentage of participants with adverse events and severity of cytokine release syndrome (CRS) determined per American Society for Transplantation and Cell Therapy (ASTCT) 2019 Consensus Grading Criteria from screening up to approximately 40 months 3. Change from baseline in targeted vital signs measured using clinical examination at every visit from screening up to approximately 40 months 4. Change from baseline in targeted clinical laboratory test results measured using blood and urine samples at multiple timepoints from screening up to approximately 40 months 5. Percentage of participants with dose interruptions, dose reductions, dose intensity, and treatment discontinuation due to adverse events recorded from screening up to approximately 40 months 6. Overall response rate (ORR) as per Independent Review Committee (IRC) according to the 2014 Lugano Response Criteria for Malignant Lymphoma from screening up to approximately 40 months 7. ORR as per investigator from screening up to approximately 40 months 8. Complete response rate (CRR) as per IRC from screening up to approximately 40 months 9. CRR as per investigator from screening up to approximately 40 months 10. Duration of objective response (DOR) as per IRC from screening up to approximately 40 months 11. DOR as per investigator from screening up to approximately 40 months 12. Duration of complete response (CR) as per IRC from screening up to approximately 40 months 13. Duration of CR as per investigator from screening up to approximately 40 months 14. Progression-free survival (PFS) as per IRC from screening up to approximately 40 months 15. PFS as per investigator from screening up to approximately 40 months 16. Overall survival (OS) from screening up to approximately 40 months 17. Number of | — |
Countries
China
Outcome results
None listed