Status:
COMPLETED
A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label, multicenter, global study is designed to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab in partic...
Eligibility Criteria
Inclusion
- Histologically documented, CD20-positive, relapsed or refractory (defined as having relapsed within 6 months to the previous treatment) FL or DLBCL (including primary mediastinal large B-cell lymphoma \[PMLBCL\])
- Bone marrow biopsy at screening (unless it was performed within 3 months prior to screening)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Life expectancy greater than or equal to (\>=) 12 weeks
- Has a QT interval corrected by Fridericia's formula (QTcF) less than or equal to (\<=) 480 milliseconds (msec)
- At least one bi-dimensionally measurable nodal lesion \>1.5 cm in its longest diameter by computed tomography (CT) scan or MRI, as defined by the Lugano Classification
- Adequate hematologic and end-organ function
- Archival tumor tissue
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 90 days after the last dose of atezolizumab or 18 months after the last dose of obinutuzumab, whichever is longer
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
Exclusion
- Known central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation from an indolent lymphoma to a high-grade or DLBCL
- Grade 3b FL, small lymphocytic lymphoma (SLL), or Waldenström's macroglobulinemia (WM) or other lymphoma subtypes except as stated in the inclusion criteria
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); participants with indwelling catheters are eligible
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homolog 2 (EZH2)
- Regular treatment with corticosteroids within the 2 or 4 weeks prior to the start of Cycle 1, unless administered for indications other than non-Hodgkin's lymphoma at a dose equivalent to \< 30 mg/day prednisone/prednisolone
- Pregnant and lactating women
- History of autoimmune disease
- Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
- Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest CT scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed
- Positive test for Human Immunodeficiency Virus (HIV)
- History of chronic hepatitis B infection or positive test results for active or chronic hepatitis B or hepatitis C
- Significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
- Hypersensitivity or prior treatment with obinutuzumab
- Fludarabine or Campath within 12 months prior to study entry
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including but not limited to interferon, interleukin-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
- Treatment with systemic immunosuppressive medications, including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents within 2 weeks prior to Cycle 1, Day 1; inhaled corticosteroids and mineralocorticoids are allowed
- Participants with active tuberculosis (TB) will be excluded from the clinical trial
Key Trial Info
Start Date :
December 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02220842
Start Date
December 18 2014
End Date
January 21 2020
Last Update
January 27 2020
Active Locations (15)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46805
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Sloan Kettering Cancer Center
New York, New York, United States, 10065-6007