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• Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
• Patients who have had systemic anticancer therapy (e.g., chemotherapy, targeted therapy including PARP inhibitors or bevacizumab) within 3 weeks prior to entering the study (30-OCT-2020)
• Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study
• Patients with prior treatment with anti-programmed cell death (PD)-1, anti- programmed cell death ligand (PD-L)1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 therapeutic antibody or other similar agents (10/16/2017)
• Patients with prior treatment with bevacizumab (or any other anti vascular therapy, e.g., cediranib) for platinum resistant recurrence; (Note: prior bevacizumab in initial therapy and/or platinum sensitive recurrent setting is allowed) (10/16/2017)
• Patients with prior treatment with PLD
• Prior radiotherapy to the abdomen or pelvis
• Patients who have not recovered from adverse events to =< grade 1 (other than alopecia) due to agents administered more than 3 weeks earlier (10/16/2017); however, the following therapies are allowed:
• Hormone replacement therapy or oral contraceptives
• Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be
discontinued at least 1 week prior to cycle 1, day 1)
• Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
• Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks 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
• Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-
time dose of dexamethasone for nausea or steroids as computed tomography [CT] scan contrast
premedication) may be enrolled
• The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with
orthostatic hypotension or adrenocortical insufficiency is allowed
• Patients taking bisphosphonate therapy for symptomatic hypercalcemia within the past 28 days; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
• Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
• Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following
criteria are met:
• Evaluable or measurable disease outside the CNS
• No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic
apparatus (optic nerves and chiasm)
• No history of intracranial hemorrhage or spinal cord hemorrhage
• No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of
anticonvulsants are permitted
• No neurosurgical resection or brain biopsy within 28 days prior to cycle 1, day 1
• Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed
above are met as well as the following:
• Radiographic demonstration of improvement upon the completion of CNS directed therapy and no
evidence of interim progression between the completion of CNS directed therapy and the
screening radiographic study
• No stereotactic radiation or whole-brain radiation within 28 days prior to cycle 1, day 1
• Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks
from discontinuation of corticosteroids
• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface
antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are
eligible
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction
(PCR) is negative for HCV ribonucleic acid (RNA)
• History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, heumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis (02/20/2019)
• Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone
are eligible
• Patients with controlled type 1 diabetes mellitus on a stable insulin regimen, or type 2 diabetes mellitus
are eligible
• Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations
only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the
following conditions:
• Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular
manifestations
• Rash must cover less than 10% of body surface area (BSA)
• Disease is well controlled at baseline and only requiring low potency topical steroids (e.g.,
hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%,
alclometasone dipropionate 0.05%)
• No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen
plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin
inhibitors; high potency or oral steroids)
• 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; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Patients with active tuberculosis (TB) are excluded
• Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
• Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
• Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for 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 and up to 5 months after the last dose of atezolizumab (06/29/2017)
• Influenza vaccination should be given during influenza season only (approximately October to March);
patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at
any time during the study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial (08-JAN-2021)
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years, with the exception of those with a negligible risk of metastases or death, such as carcinoma in situ of the breast or cervix
• Severe, active co-morbidity defined as follows:
• Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel obstruction
• Patients who require parental hydration and/or nutrition
• Patients who require drainage gastrostomy tube
• Evidence of bleeding diathesis or clinically significant coagulopathy
• Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture
• History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study
enrollment
• Significant cardiovascular or cerebrovascular disease including:
• Uncontrolled hypertension (systolic blood pressure [SBP] >= 150 and/or diastolic blood pressure [DBP]
>= 90)
• History of myocardial infarction within 6 months
• Unstable angina
• New York Heart Association functional classification II, III or IV
• Baseline ejection fraction =< 50% as assessed by echocardiogram or multi-gated acquisition (MUGA)
• Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or peripheral arterial
thrombosis) within 6 months
• History of abdominal/pelvic or tracheoesophageal fistula or gastrointestinal perforation and/or
abdominal/pelvic abscess within 6 months prior to initiation of treatment (02/20/2019)
• Pregnant or lactating patients
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