A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

  • STATUS
    Recruiting
  • End date
    Mar 31, 2026
  • participants needed
    169
  • sponsor
    Hoffmann-La Roche
Updated on 11 October 2022
ct scan
monoclonal antibodies
lenalidomide
follicular lymphoma
avid
fludeoxyglucose f-18
obinutuzumab
refractory follicular lymphoma

Summary

This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab + lenalidomide 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.

Details
Condition Follicular Lymphoma
Treatment Tocilizumab, Obinutuzumab, Lenalidomide, Mosunetuzumab, Glofitamab, Mosunetuzumab (IV), Mosunetuzumab (SC)
Clinical Study IdentifierNCT04246086
SponsorHoffmann-La Roche
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
R/R FL after treatment with at least one prior chemo immunotherapy regimen that included an anti CD20 monoclonal antibody (MAb)
Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 at time of diagnosis as determined by the local laboratory
Previously untreated participants with FL must require systemic therapy assessed by investigator based on the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)
At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of FL
Agreement to comply with all local requirements of the Len risk minimization plan
Adequate hematologic function (unless due to underlying lymphoma, per the investigator) as defined by the protocol
For women of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period, and for at least 12 months after the final dose of glofitamab, 28 days after the last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun. Women must refrain from donating eggs during this same period
Normal laboratory values (unless due to underlying lymphoma) as defined by the protocol
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun

Exclusion Criteria

Documented refractoriness to an obinutuzumab monotherapy containing regimen in glofitamab-containing treatment combination
Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
Any history of Grade 3b FL
Any history of transformation and/or diffuse large B-cell lymphoma (DLBCL)
Documented refractoriness to lenalidomide, defined as no response (partial response (PR) or complete response (CR)) within 6 months of therapy
Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
Prior standard or investigational anti-cancer therapy as specified by the protocol
Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
History of solid organ transplantation
Known history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
History of severe allergic or anaphylactic reaction to humanized, chimeric or murine MAbs
Known sensitivity or allergy to murine products
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the glofitamab, Mosun, G, Len, or thalidomide formulation, including mannitol
History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
Known or suspected chronic active Epstein-Barr virus infection or hemophagocytic syndrome
Active Hepatitis B and Hepatitis C infection or autoimmune disease requiring treatment
Known history of HIV positive status
History of progressive multifocal leukoencephalopathy
Known history of macrophage activating syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
Prior allogenic hematopoietic stem cell transplant
Prior allogenic hematopoietic stem cell transplant (HSCT)
Contraindication to treatment for thromboembolism prophylaxis
Grade >=2 neuropathy
Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to significant cardiovascular disease or significant pulmonary disease
Other malignancy that could affect compliance with the protocol or interpretation of results
Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Inadequate hematologic function
Any of the following abnormal laboratory values
Pregnant or lactating or intending to become pregnant during the study
Life expectancy < 3 months
Unable to comply with the study protocol, in the investigator's judgment
History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or Medical Monitor's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
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