{
    "info": {
        "nct_id": "NCT02323191",
        "official_title": "Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Eastern Cooperative Oncology Group performance status 0 or 1\n* Participants must have histologically confirmed diagnosis of locally advanced and/or metastatic triple negative breast cancer, ovarian cancer, bladder cancer, gastric cancer, or soft tissue sarcoma, with exceptions defined in the exclusion criteria\n* Measurable disease at baseline as per RECIST version 1.1\n* Life expectancy of greater than or equal to (>=) 16 weeks\n* Adequate bone marrow, liver, cardiac, and renal function\n* Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than or equal to (<=) 12 months post-menopause. Postmenopausal state is defined as amenorrhea for greater than (>) 12 months.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Allergy or hypersensitivity to components of the emactuzumab formulation or to components of the atezolizumab formulation\n* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening (within 28 days before C1D1) and prior radiographic assessments. Participants with radiographically stable, asymptomatic previously irradiated lesions are eligible provided participant is >= 4 weeks beyond completion of cranial irradiation and >= 3 weeks off of corticosteroid therapy. Participants with metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm) are completely excluded\n* Leptomeningeal disease\n* History of or active autoimmune disease\n* Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm)\n* Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the exceptions provided in the protocol\n* Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug\n* Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade <=1 severity (Common Terminology Criteria for Adverse Events [CTCAE] v4.03, or later versions)\n* History of human immunodeficiency virus (HIV)\n* Participants with active hepatitis B, active hepatitis C, or active tuberculosis\n* Participant has had pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry\n* Participants has a history of hematological malignancy within the last 5 years prior to study entry\n* Treatment with systemic immunosuppressive medications - Pregnant or lactating women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Eastern Cooperative Oncology Group performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status 0 or 1",
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have histologically confirmed diagnosis of locally advanced and/or metastatic triple negative breast cancer, ovarian cancer, bladder cancer, gastric cancer, or soft tissue sarcoma, with exceptions defined in the exclusion criteria",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced and/or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "triple negative breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "triple negative breast cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "ovarian cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "bladder cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "bladder cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "gastric cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "soft tissue sarcoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "soft tissue sarcoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease at baseline as per RECIST version 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease at baseline",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as per RECIST version 1.1",
                    "criterion": "RECIST version",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": "1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of greater than or equal to (>=) 16 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than or equal to (>=) 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow, liver, cardiac, and renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... cardiac",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than or equal to (<=) 12 months post-menopause. Postmenopausal state is defined as amenorrhea for greater than (>) 12 months.",
            "criterions": [
                {
                    "exact_snippets": "Negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to study treatment",
                    "criterion": "timing of serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "premenopausal women",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "women less than or equal to (<=) 12 months post-menopause",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration post-menopause",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Postmenopausal state is defined as amenorrhea for greater than (>) 12 months",
                    "criterion": "postmenopausal state",
                    "requirements": [
                        {
                            "requirement_type": "amenorrhea duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Allergy or hypersensitivity to components of the emactuzumab formulation or to components of the atezolizumab formulation",
            "criterions": [
                {
                    "exact_snippets": "Allergy or hypersensitivity to components of the emactuzumab formulation",
                    "criterion": "allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy or hypersensitivity ... to components of the atezolizumab formulation",
                    "criterion": "allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening (within 28 days before C1D1) and prior radiographic assessments. Participants with radiographically stable, asymptomatic previously irradiated lesions are eligible provided participant is >= 4 weeks beyond completion of cranial irradiation and >= 3 weeks off of corticosteroid therapy. Participants with metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm) are completely excluded",
            "criterions": [
                {
                    "exact_snippets": "Active or untreated central nervous system (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "untreated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening (within 28 days before C1D1) and prior radiographic assessments",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "determination method",
                            "expected_value": [
                                "CT",
                                "MRI"
                            ]
                        },
                        {
                            "requirement_type": "screening time frame",
                            "expected_value": "within 28 days before C1D1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with radiographically stable, asymptomatic previously irradiated lesions are eligible",
                    "criterion": "previously irradiated lesions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "radiographically stable"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "provided participant is >= 4 weeks beyond completion of cranial irradiation",
                    "criterion": "cranial irradiation completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": ">= 3 weeks off of corticosteroid therapy",
                    "criterion": "corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "time off therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm) are completely excluded",
                    "criterion": "metastases location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "brain stem",
                                "midbrain",
                                "pons",
                                "medulla"
                            ]
                        },
                        {
                            "requirement_type": "proximity to optic apparatus",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "Leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of or active autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "History of or active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm)",
            "criterions": [
                {
                    "exact_snippets": "significant, uncontrolled concomitant diseases",
                    "criterion": "uncontrolled concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association Class III or IV cardiac disease",
                    "criterion": "New York Heart Association cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 6 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "obstructive pulmonary disease",
                    "criterion": "obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of symptomatic bronchospasm",
                    "criterion": "symptomatic bronchospasm",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the exceptions provided in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug",
            "criterions": [
                {
                    "exact_snippets": "Prior corticosteroids as anti-cancer therapy",
                    "criterion": "corticosteroids as anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within a minimum of 14 days of first receipt of study drug",
                    "criterion": "time since last corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade <=1 severity (Common Terminology Criteria for Adverse Events [CTCAE] v4.03, or later versions)",
            "criterions": [
                {
                    "exact_snippets": "Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade <=1 severity (Common Terminology Criteria for Adverse Events [CTCAE] v4.03, or later versions)",
                    "criterion": "prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade (CTCAE v4.03, or later versions)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of human immunodeficiency virus (HIV)",
            "criterions": [
                {
                    "exact_snippets": "History of human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with active hepatitis B, active hepatitis C, or active tuberculosis",
            "criterions": [
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has had pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other thrombo-embolic event",
                    "criterion": "thrombo-embolic event",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months prior to study entry",
                    "criterion": "time since thrombo-embolic event",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants has a history of hematological malignancy within the last 5 years prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "history of hematological malignancy within the last 5 years",
                    "criterion": "hematological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with systemic immunosuppressive medications - Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Treatment with systemic immunosuppressive medications",
                    "criterion": "systemic immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "pregnancy or lactation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}