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A clinical trial to look at the safety and effectiveness of mosunetuzumab plus lenalidomide for treating follicular lymphoma
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
- Follicular Lymphoma
Trial Status:
Recruiting
This trial runs in
Countries
- China
- France
- Spain
- United Kingdom
- United States
Trial Identifier:
NCT04246086 2019-004291-20 CO41942
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT04246086 , CO41942 , 2019-004291-20
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
How does the CO41942 clinical trial work?
This clinical trial is recruiting people who have a type of cancer called follicular lymphoma (FL). The purpose of this clinical trial is to test the safety and effectiveness of mosunetuzumab in combination with lenalidomide. The trial will also help researchers to understand how your body processes this combination of drugs.
There are two parts to this clinical trial: a non-randomised stage and a randomised stage:
• The non-randomised stage will test the safety and effectiveness of mosunetuzumab in combination with lenalidomide.
• The randomised stage will test the safety and effectiveness of mosunetuzumab given as an infusion through the vein compared with an injection under the skin, each in combination with lenalidomide.
Both stages will also help to find out the effects these drugs have on you and your FL.
How do I take part in this clinical trial?
People can take part in this trial if they are at least 18 years old, have been diagnosed with FL or if their FL has either not improved after previous treatment with chemo-immunotherapy or come back after you finished treatment (‘relapsed’ or ‘refractory’). If you have not received treatment for your FL, you can take part in this clinical trial if a doctor who runs the trial confirms that you need treatment.
People may not be able to take part in this trial if their cancer is ‘high-grade’ when the clinical trial starts, or at any time in the past, and it cannot have spread to the brain or spinal cord. If you have received certain previous treatments for your cancer, you may not be able to take part. You must not have any other significant medical conditions or be pregnant or breastfeeding.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
This clinical trial is open-label, which means that everyone involved including the participants and the doctors, know the clinical trial treatment participants have been given. Treatments in this clinical trial are:
· Non-randomised stage
o Mosunetuzumab given as an infusion into the vein or as an injection under the skin, and lenalidomide given as a tablet to take by mouth
· Randomised stage
Everyone who joins this clinical trial stage will be placed into 1 of 2 groups by chance (like flipping a coin) and given either:
o Group A: Mosunetuzumab given as an infusion into the vein, and lenalidomide given as a tablet to take by mouth
o Group B: Mosunetuzumab given as an injection under the skin, and lenalidomide given as a tablet to take by mouth
People who have certain side effects may also receive a treatment called tocilizumab, given as an infusion into the vein. Treatments in this clinical trial will be given for as long as they can help you, up to a maximum of 12 rounds of treatment (approximately 1 year).
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatments for as long as it can help you, up to a maximum of 12 rounds of treatment (approximately 1 year). Throughout the treatment period, you will need to attend regular hospital visits, which will include checks to see how you are responding to the treatment and any side effects that you may be having. You are free to stop treatment at any time. After being given your last dose, you will be contacted by the clinical trial staff approximately every 6 months for 2 years, as long as you agree to it.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor may suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04246086
Trial-identifier: NCT04246086
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT04246086 , CO41942 , 2019-004291-20
Trial Identifier
Mosunetuzumab (IV), Tocilizumab, Lenalidomide, Mosunetuzumab (SC)
Treatments
Follicular Lymphoma
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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)
- Previously untreated participants with FL must require systemic therapy assessed by investigator based on the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 at time of diagnosis as determined by the local laboratory
- 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
- Adequate hematologic function (unless due to underlying lymphoma, per the investigator) as defined by the protocol
- Normal laboratory values (unless due to underlying lymphoma) as defined by the protocol
- Agreement to comply with all local requirements of the Len risk minimization plan
- 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
- 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
- Any history of Grade 3b FL
- Any history of transformation and/or diffuse large B-cell lymphoma (DLBCL)
- 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
- Documented refractoriness to lenalidomide, defined as no response (partial response (PR) or complete response (CR)) within 6 months of therapy
- Prior standard or investigational anti-cancer therapy as specified by the protocol
- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
- 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
- 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
- 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
- Known history of macrophage activating syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- Active Hepatitis B and Hepatitis C infection or autoimmune disease requiring treatment
- Prior allogenic hematopoietic stem cell transplant
- Known history of HIV positive status
- History of progressive multifocal leukoencephalopathy
- 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
- Other malignancy that could affect compliance with the protocol or interpretation of results
- 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
- 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
For the latest version of this information please go to www.forpatients.roche.com