Non Hodgkin Lymphoma Clinical Trial

A Study of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Summary

This study will investigate the safety, pharmacology, and activity of atezolizumab in combination with immunotherapy agents with or without an anti-CD20 agent (i.e., obinutuzumab) in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The first immunotherapy molecule investigated will be emactuzumab (Arm A) in two combinations.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Life expectancy ≥ 12 weeks
At least two bi-dimensionally measurable nodal lesions ≥ 1.5 centimeters (cm) in its longest diameter by imaging
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Consent to collection of a pre-treatment tumor sample, on-treatment biopsy, and, if applicable, a tumor tissue sample at the time of progressive disease (PD)

Inclusion Criteria Specific to Obinutuzumab-Containing Cohorts

- Patients receiving therapeutic anticoagulation should be switched to low molecular weight heparin (LMWH) before the first cycle of obinutuzumab

Exclusion Criteria:

Any approved systemic anti-cancer therapy (including chemotherapy) or hormonal therapy within 3 weeks prior to initiation of study treatment
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
Known central nervous system (CNS) lymphoma, leptomeningeal lymphoma
Grade 3b FL, small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), or other lymphoma subtypes except as stated in the inclusion criteria
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled hypercalcemia
History of other malignancy within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Known hypersensitivity to any of the study drugs
History of sensitivity to mannitol
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
Pregnant and lactating women
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation, emactuzumab formulation, or obinutuzumab formulation
History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis (RA), inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Patients 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 computed tomography (CT) scan at screening
Serum albumin < 2.5 g/dL
Positive test for HIV (human immunodeficiency virus)
All patients will have a tuberculin (purified protein derivative [PPD]) skin test or interferon-gamma release assay (IGRA) done locally prior to the inclusion into the study. Patients with active tuberculosis (TB) will be excluded from the study.
History of chronic hepatitis B virus (HBV) infection or positive test results for active or chronic HBV infection defined by hepatitis B surface antigen (HBsAg)
Patients with active or chronic hepatitis C virus (HCV)
Active TB
Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
Significant cardiovascular disease, such as cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 or anticipation of a major surgical procedure during the course of the study
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
Prior treatment with CD137 agonists or immune checkpoint blockade therapies
Treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)) within 2 weeks prior to Cycle 1, Day 1
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed

Exclusion Criteria Specific to Obinutuzumab-Containing Cohorts:

Hypersensitivity to obinutuzumab

Prior treatment with obinutuzumab
Fludarabine or Campath within 12 months prior to study entry
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom dosing with obinutuzumab would be contraindicated for safety reasons)
Received therapeutic oral or IV antibiotics within 4 weeks prior to Cycle 1, Day 1 (except for tumor fever)
Patients with history of confirmed progressive multifocal leukoencephalopathy
Regular treatment with corticosteroids within the 4 weeks prior to the start of Cycle 1, unless administered for indications other than NHL at a dose equivalent to < 30 mg/day prednisone/prednisolone

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT03369964

Recruitment Status:

Withdrawn

Sponsor:

Hoffmann-La Roche

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There are 2 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT03369964

Recruitment Status:

Withdrawn

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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