A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Exclusion Criteria

• •Participants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation.
• •Participants who have received immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications, and any herbal medicines within 1 month prior to study treatment initiation. NOTE: Physiologic doses of systemic steroids (\<= 10 mg prednisone or equivalent) or local (e.g., topical, nasal, intraarticular, inhaled) steroid use is permitted.
• •Prior treatment with CD137 agonists
• •Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation.
• •History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:
• •* Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.
• •* Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.
• •* Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:
• •* Rash must cover less than 10% of body surface area (BSA)
• •* Disease is well controlled at screening and only requiring low potency topical steroids
• •* No acute exacerbations of underlying condition within 12 months prior to study treatment initiation (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within 12 months prior to study treatment initiation.
• •Persisting toxicity related to prior therapy of Grade \>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 unless deemed not clinically significant or irreversible. NOTE: alopecia and sensory neuropathy Grade \<= 2 are acceptable.
• •Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
• •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
• •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
• •Active tuberculosis at screening
• •History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• •Participants with significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident (https://www.heart.org/en/health-topics/heart-failure/what-isheart-failure/classes-of-heart-failure), unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.
• •Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in IOCBP performed at screening).
• •Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.