{
    "info": {
        "nct_id": "NCT02637531",
        "official_title": "A Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination With Nivolumab in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "All subjects must meet the following criteria for inclusion:\n\n* ≥ 18 years of age\n* Life expectancy of ≥ 3 months\n* Histological or cytological evidence of advanced and/or metastatic carcinoma or melanoma , excluding sarcoma\n* At least 1 measurable disease lesion as defined by RECIST 1.1\n* Serum creatinine clearance ≥ 60 mL/min and serum creatinine ≤ 2.0 x the upper limit of normal (ULN) as determined by either of the following: Estimation as calculated by Cockcroft-Gault equation or Direct measurement by 24-hour urine collection\n* Total bilirubin ≤ 1.5 x ULN (unless elevated due to Gilbert's syndrome)\n* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 x ULN (<5x ULN if liver metastasis)\n* Adequate hematological function, defined as absolute neutrophil count ≥1.5 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (corresponds to Karnofsky Performance Status (KPS) ≥ 60%)\n\nSubjects entering Part A, B, C, or D must also meet the following additional criterion:\n\n• Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgement of the Investigator)\n\nSubjects entering Part D, E, F or G must also meet the following additional criterion:\n\n• Willing to undergo 1 pre-treatment and 1 on-treatment tumor biopsy\n\nSubjects entering Part E must also meet the following additional criteria:\n\n* Histological or cytological evidence of NSCLC, melanoma, , human papillomavirus (HPV) positive or HPV negative SCCHN (oral cavity, pharynx, hypopharynx, larynx, nasopharyngeal [including undifferentiated nasopharyngeal carcinoma]), or another tumor type to be determined\n* Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the Investigator The most recent treatment prior to study entry must be an anti-PD-1 or anti-PD-L1 antibody given as either monotherapy or in combination\n* Subjects with NSCLC Tumors that harbor an actionable genetic alteration for which there is a corresponding approved therapy for that specific alteration (including but not limited to alterations in EGFR, ALK, and ROS) must have progressed on, or had intolerance to, the respective therapy\n\nSubjects entering Part F must also meet the following additional criteria:\n\n* Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue; or another tumor type to be determined\n\n  * ER/PgR negativity to follow local guidelines\n  * If IHC HER2 2+, a negative FISH test is required\n  * Inflammatory triple negative breast cancer is allowed\n* Must have received and failed/progressed a cytotoxic chemotherapy as first line therapy per standard of care\n* No prior anti-PD-1 or anti-PD-L1 therapy\n\nSubjects entering Part G must also meet the following additional criteria:\n\n* Histological or cytological evidence of ACC, mesothelioma, or another tumor type to be determined\n\n  * Both pleural and peritoneal mesothelioma are allowed\n  * Epithelioid, sarcomatoid, or biphasic mesothelioma subtypes are allowed\n* Progression after at least first line available therapy\n\nPatients entering Part H must also meet the following additional criteria:\n\nHigh-circulating MDSCs, currently defined for this study as MDSCs\n\n≥ 20.5% as measured by CLIA-certified Serametrix assay Microsatellite status of tumor has been determined Patients with tumors that are microsatellite instability-high must have previously received an anti-PD-1/anti-PD-L1 therapy and progressed on therapy If patient's tumor type is one for which anti-PD-1/anti-PD-L1 therapy is standard of care, patient must have previously received an anti-PD-1 or anti-PD-L1 therapy and progressed while on that therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Subjects are to be excluded from the study if they meet any of the following criteria:\n\n* Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any excipient in the study drugs\n* Major surgery within 4 weeks prior to Screening\n* Subjects who have been treated with chemotherapy, biologic therapy, or other investigational agent within < 5 times the half-life of the agent or < 28 days (whichever is shorter) of starting study drug\n\nNOTE: Subjects whose immediate prior treatment was with nivolumab may start study drug 2 weeks after the last dose of nivolumab\n\n* Symptomatic or untreated brain metastases\n* Primary central nervous system (CNS) malignancy\n* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus\n* Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids\n* Ongoing systemic bacterial, fungal, or viral infections at Screening\n\nNOTE: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met\n\n* Administration of a live vaccine within 6 weeks of first dose of study drug\n* Administration of any of the following within 1 week prior to the administration of study drug:\n\n  * Strong inhibitors or inducers of CYP3A4, including grapefruit products and herbal supplements\n  * P-glycoprotein (P-gp) inhibitors\n  * Warfarin, phenytoin, or other substrates of CYP2C8 or CYP2C9 with a narrow therapeutic range\n  * Medications associated with QTc interval prolongation or Torsades de Pointes\n* Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms (average of triplicate readings) NOTE: criterion does not apply to subjects with a right or left bundle branch block\n* Parts C, D-Annex, and E only: Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)\n* Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* History of peptic ulcer and/or gastrointestinal bleed\n* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening\n* Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the subject associated with his or her participation in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological evidence of advanced and/or metastatic carcinoma or melanoma , excluding sarcoma",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological evidence of advanced and/or metastatic carcinoma or melanoma",
                    "criterion": "carcinoma or melanoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced and/or metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding sarcoma",
                    "criterion": "sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 measurable disease lesion as defined by RECIST 1.1",
            "criterions": [
                {
                    "exact_snippets": "At least 1 measurable disease lesion",
                    "criterion": "measurable disease lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine clearance ≥ 60 mL/min and serum creatinine ≤ 2.0 x the upper limit of normal (ULN) as determined by either of the following: Estimation as calculated by Cockcroft-Gault equation or Direct measurement by 24-hour urine collection",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine clearance ≥ 60 mL/min",
                    "criterion": "serum creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ≤ 2.0 x the upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 x ULN (unless elevated due to Gilbert's syndrome)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless elevated due to Gilbert's syndrome",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 x ULN (<5x ULN if liver metastasis)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST/SGOT) ... ≤ 2.5 x ULN (<5x ULN if liver metastasis)",
                    "criterion": "Aspartate aminotransferase (AST/SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level with liver metastasis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT/SGPT) ... ≤ 2.5 x ULN (<5x ULN if liver metastasis)",
                    "criterion": "alanine aminotransferase (ALT/SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level with liver metastasis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematological function, defined as absolute neutrophil count ≥1.5 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematological function, defined as absolute neutrophil count ≥1.5 x 109/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematological function, defined as ... hemoglobin ≥ 9.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematological function, defined as ... platelet count ≥ 100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (corresponds to Karnofsky Performance Status (KPS) ≥ 60%)",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky Performance Status (KPS) ≥ 60%",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects entering Part A, B, C, or D must also meet the following additional criterion:",
            "criterions": [
                {
                    "exact_snippets": "Subjects entering Part A, B, C, or D",
                    "criterion": "trial part entry",
                    "requirements": [
                        {
                            "requirement_type": "entry",
                            "expected_value": [
                                "Part A",
                                "Part B",
                                "Part C",
                                "Part D"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgement of the Investigator)",
            "criterions": [
                {
                    "exact_snippets": "Failure to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no appropriate therapies are available",
                    "criterion": "availability of appropriate therapies",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects entering Part D, E, F or G must also meet the following additional criterion:",
            "criterions": [
                {
                    "exact_snippets": "Subjects entering Part D, E, F or G",
                    "criterion": "trial part",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "Part D",
                                "Part E",
                                "Part F",
                                "Part G"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Willing to undergo 1 pre-treatment and 1 on-treatment tumor biopsy",
            "criterions": [
                {
                    "exact_snippets": "Willing to undergo 1 pre-treatment ... tumor biopsy",
                    "criterion": "pre-treatment tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to undergo ... 1 on-treatment tumor biopsy",
                    "criterion": "on-treatment tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects entering Part E must also meet the following additional criteria:",
            "criterions": [
                {
                    "exact_snippets": "Subjects entering Part E",
                    "criterion": "part E entry",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological evidence of NSCLC, melanoma, , human papillomavirus (HPV) positive or HPV negative SCCHN (oral cavity, pharynx, hypopharynx, larynx, nasopharyngeal [including undifferentiated nasopharyngeal carcinoma]), or another tumor type to be determined",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological evidence of NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological evidence of ... melanoma",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological evidence of ... human papillomavirus (HPV) positive or HPV negative SCCHN",
                    "criterion": "SCCHN",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        },
                        {
                            "requirement_type": "HPV status",
                            "expected_value": [
                                "positive",
                                "negative"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological evidence of ... another tumor type to be determined",
                    "criterion": "another tumor type",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the Investigator The most recent treatment prior to study entry must be an anti-PD-1 or anti-PD-L1 antibody given as either monotherapy or in combination",
            "criterions": [
                {
                    "exact_snippets": "Failure to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failure"
                        }
                    ]
                },
                {
                    "exact_snippets": "no appropriate therapies are available",
                    "criterion": "availability of appropriate therapies",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The most recent treatment prior to study entry must be an anti-PD-1 or anti-PD-L1 antibody",
                    "criterion": "most recent treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "anti-PD-1 antibody",
                                "anti-PD-L1 antibody"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "given as either monotherapy or in combination",
                    "criterion": "treatment administration",
                    "requirements": [
                        {
                            "requirement_type": "administration type",
                            "expected_value": [
                                "monotherapy",
                                "combination"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with NSCLC Tumors that harbor an actionable genetic alteration for which there is a corresponding approved therapy for that specific alteration (including but not limited to alterations in EGFR, ALK, and ROS) must have progressed on, or had intolerance to, the respective therapy",
            "criterions": [
                {
                    "exact_snippets": "NSCLC Tumors",
                    "criterion": "NSCLC tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "harbor an actionable genetic alteration",
                    "criterion": "actionable genetic alteration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "corresponding approved therapy for that specific alteration",
                    "criterion": "approved therapy for genetic alteration",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alterations in EGFR, ALK, and ROS",
                    "criterion": "genetic alterations",
                    "requirements": [
                        {
                            "requirement_type": "specific genes",
                            "expected_value": [
                                "EGFR",
                                "ALK",
                                "ROS"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must have progressed on, or had intolerance to, the respective therapy",
                    "criterion": "progression or intolerance to therapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "progressed or intolerant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects entering Part F must also meet the following additional criteria:",
            "criterions": [
                {
                    "exact_snippets": "Subjects entering Part F",
                    "criterion": "Part F entry",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue; or another tumor type to be determined",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological evidence of estrogen-receptor negative (ER-)",
                    "criterion": "estrogen-receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor negative (PgR-)",
                    "criterion": "progesterone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "human epidermal growth factor-2 receptor negative (HER2-)",
                    "criterion": "human epidermal growth factor-2 receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Breast Cancer by local laboratory testing, based on last available tumor tissue",
                    "criterion": "Breast Cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "local laboratory testing"
                        },
                        {
                            "requirement_type": "basis",
                            "expected_value": "last available tumor tissue"
                        }
                    ]
                },
                {
                    "exact_snippets": "another tumor type to be determined",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "to be determined"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ER/PgR negativity to follow local guidelines",
            "criterions": [
                {
                    "exact_snippets": "ER/PgR negativity",
                    "criterion": "ER/PgR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If IHC HER2 2+, a negative FISH test is required",
            "criterions": [
                {
                    "exact_snippets": "IHC HER2 2+",
                    "criterion": "IHC HER2",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "2+"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative FISH test is required",
                    "criterion": "FISH test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inflammatory triple negative breast cancer is allowed",
            "criterions": [
                {
                    "exact_snippets": "Inflammatory triple negative breast cancer is allowed",
                    "criterion": "inflammatory triple negative breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have received and failed/progressed a cytotoxic chemotherapy as first line therapy per standard of care",
            "criterions": [
                {
                    "exact_snippets": "Must have received ... a cytotoxic chemotherapy",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "failed/progressed a cytotoxic chemotherapy",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": [
                                "failed",
                                "progressed"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "first line therapy",
                    "criterion": "line of therapy",
                    "requirements": [
                        {
                            "requirement_type": "order",
                            "expected_value": "first"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior anti-PD-1 or anti-PD-L1 therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior anti-PD-1 ... therapy",
                    "criterion": "anti-PD-1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... anti-PD-L1 therapy",
                    "criterion": "anti-PD-L1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects entering Part G must also meet the following additional criteria:",
            "criterions": [
                {
                    "exact_snippets": "Subjects entering Part G",
                    "criterion": "Part G entry",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological evidence of ACC, mesothelioma, or another tumor type to be determined",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological evidence of ACC",
                    "criterion": "ACC",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological evidence of ... mesothelioma",
                    "criterion": "mesothelioma",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological or cytological evidence of ... another tumor type to be determined",
                    "criterion": "another tumor type",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological or cytological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Epithelioid, sarcomatoid, or biphasic mesothelioma subtypes are allowed",
            "criterions": [
                {
                    "exact_snippets": "Epithelioid, sarcomatoid, or biphasic mesothelioma subtypes",
                    "criterion": "mesothelioma subtype",
                    "requirements": [
                        {
                            "requirement_type": "allowed subtypes",
                            "expected_value": [
                                "epithelioid",
                                "sarcomatoid",
                                "biphasic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression after at least first line available therapy",
            "criterions": [
                {
                    "exact_snippets": "Progression after at least first line available therapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment line",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "High-circulating MDSCs, currently defined for this study as MDSCs",
            "criterions": [
                {
                    "exact_snippets": "High-circulating MDSCs",
                    "criterion": "circulating MDSCs",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "≥ 20.5% as measured by CLIA-certified Serametrix assay Microsatellite status of tumor has been determined Patients with tumors that are microsatellite instability-high must have previously received an anti-PD-1/anti-PD-L1 therapy and progressed on therapy If patient's tumor type is one for which anti-PD-1/anti-PD-L1 therapy is standard of care, patient must have previously received an anti-PD-1 or anti-PD-L1 therapy and progressed while on that therapy",
            "criterions": [
                {
                    "exact_snippets": "≥ 20.5% as measured by CLIA-certified Serametrix assay",
                    "criterion": "Serametrix assay result",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20.5,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Microsatellite status of tumor has been determined",
                    "criterion": "microsatellite status of tumor",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with tumors that are microsatellite instability-high must have previously received an anti-PD-1/anti-PD-L1 therapy and progressed on therapy",
                    "criterion": "microsatellite instability-high tumor",
                    "requirements": [
                        {
                            "requirement_type": "previous anti-PD-1/anti-PD-L1 therapy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression on therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If patient's tumor type is one for which anti-PD-1/anti-PD-L1 therapy is standard of care, patient must have previously received an anti-PD-1 or anti-PD-L1 therapy and progressed while on that therapy",
                    "criterion": "tumor type with standard of care anti-PD-1/anti-PD-L1 therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous anti-PD-1/anti-PD-L1 therapy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression on therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any excipient in the study drugs",
            "criterions": [
                {
                    "exact_snippets": "Severe allergic or anaphylactic reaction to any monoclonal antibody therapy",
                    "criterion": "allergic or anaphylactic reaction to monoclonal antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe allergic or anaphylactic reaction to any ... murine protein",
                    "criterion": "allergic or anaphylactic reaction to murine protein",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to any excipient in the study drugs",
                    "criterion": "hypersensitivity to excipient in study drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks prior to Screening",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior to Screening",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who have been treated with chemotherapy, biologic therapy, or other investigational agent within < 5 times the half-life of the agent or < 28 days (whichever is shorter) of starting study drug",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have been treated with chemotherapy",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "times the half-life of the agent"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have been treated with ... biologic therapy",
                    "criterion": "biologic therapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "times the half-life of the agent"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who have been treated with ... other investigational agent",
                    "criterion": "other investigational agent treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "times the half-life of the agent"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "NOTE: Subjects whose immediate prior treatment was with nivolumab may start study drug 2 weeks after the last dose of nivolumab",
            "criterions": [
                {
                    "exact_snippets": "Subjects whose immediate prior treatment was with nivolumab",
                    "criterion": "immediate prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "specific treatment",
                            "expected_value": "nivolumab"
                        }
                    ]
                },
                {
                    "exact_snippets": "may start study drug 2 weeks after the last dose of nivolumab",
                    "criterion": "time since last dose of nivolumab",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic or untreated brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic or untreated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary central nervous system (CNS) malignancy",
            "criterions": [
                {
                    "exact_snippets": "Primary central nervous system (CNS) malignancy",
                    "criterion": "primary CNS malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus",
            "criterions": [
                {
                    "exact_snippets": "Infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Infection with ... hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Infection with ... hepatitis C virus",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids",
            "criterions": [
                {
                    "exact_snippets": "Ongoing treatment with chronic immunosuppressants (eg, cyclosporine)",
                    "criterion": "chronic immunosuppressant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing treatment with ... systemic steroids",
                    "criterion": "systemic steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing systemic bacterial, fungal, or viral infections at Screening",
            "criterions": [
                {
                    "exact_snippets": "Ongoing systemic bacterial ... infections at Screening",
                    "criterion": "systemic bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing systemic ... fungal ... infections at Screening",
                    "criterion": "systemic fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing systemic ... viral infections at Screening",
                    "criterion": "systemic viral infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "NOTE: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met",
            "criterions": [
                {
                    "exact_snippets": "Subjects on antimicrobial, antifungal, or antiviral prophylaxis",
                    "criterion": "prophylaxis",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "antimicrobial",
                                "antifungal",
                                "antiviral"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administration of a live vaccine within 6 weeks of first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Administration of a live vaccine within 6 weeks of first dose of study drug",
                    "criterion": "live vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administration of any of the following within 1 week prior to the administration of study drug:",
            "criterions": [
                {
                    "exact_snippets": "Administration of any of the following within 1 week prior to the administration of study drug",
                    "criterion": "administration of specific treatments",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 1 week prior to study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Strong inhibitors or inducers of CYP3A4, including grapefruit products and herbal supplements",
            "criterions": [
                {
                    "exact_snippets": "Strong inhibitors or inducers of CYP3A4",
                    "criterion": "CYP3A4 interaction",
                    "requirements": [
                        {
                            "requirement_type": "interaction type",
                            "expected_value": [
                                "inhibitor",
                                "inducer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "grapefruit products",
                    "criterion": "grapefruit product consumption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "herbal supplements",
                    "criterion": "herbal supplement consumption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* P-glycoprotein (P-gp) inhibitors",
            "criterions": [
                {
                    "exact_snippets": "P-glycoprotein (P-gp) inhibitors",
                    "criterion": "P-glycoprotein (P-gp) inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Warfarin, phenytoin, or other substrates of CYP2C8 or CYP2C9 with a narrow therapeutic range",
            "criterions": [
                {
                    "exact_snippets": "Warfarin, phenytoin, or other substrates of CYP2C8 or CYP2C9",
                    "criterion": "medication use",
                    "requirements": [
                        {
                            "requirement_type": "specific medications",
                            "expected_value": [
                                "Warfarin",
                                "phenytoin",
                                "other substrates of CYP2C8",
                                "other substrates of CYP2C9"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "narrow therapeutic range",
                    "criterion": "therapeutic range",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "narrow"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medications associated with QTc interval prolongation or Torsades de Pointes",
            "criterions": [
                {
                    "exact_snippets": "Medications associated with QTc interval prolongation",
                    "criterion": "medications",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "QTc interval prolongation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Medications associated with ... Torsades de Pointes",
                    "criterion": "medications",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "Torsades de Pointes"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms (average of triplicate readings) NOTE: criterion does not apply to subjects with a right or left bundle branch block",
            "criterions": [
                {
                    "exact_snippets": "Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms",
                    "criterion": "QT interval",
                    "requirements": [
                        {
                            "requirement_type": "correction method",
                            "expected_value": "Fridericia's method"
                        },
                        {
                            "requirement_type": "baseline value",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parts C, D-Annex, and E only: Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll",
            "criterions": [
                {
                    "exact_snippets": "active, known, or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vitiligo",
                    "criterion": "vitiligo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "type I diabetes mellitus",
                    "criterion": "type I diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "residual hypothyroidism due to autoimmune condition only requiring hormone replacement",
                    "criterion": "residual hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "autoimmune condition"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement"
                        }
                    ]
                },
                {
                    "exact_snippets": "psoriasis not requiring systemic treatment",
                    "criterion": "psoriasis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "not requiring systemic treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions not expected to recur in the absence of an external trigger",
                    "criterion": "conditions not expected to recur",
                    "requirements": [
                        {
                            "requirement_type": "trigger",
                            "expected_value": "absence of an external trigger"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)",
            "criterions": [
                {
                    "exact_snippets": "Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)",
                    "criterion": "prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric bypass surgery",
                                "gastrectomy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal dysfunction that may affect drug absorption",
                    "criterion": "gastrointestinal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "effect on drug absorption",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia",
            "criterions": [
                {
                    "exact_snippets": "Concurrent active malignancy other than non-melanoma skin cancer",
                    "criterion": "concurrent active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate intraepithelial neoplasia",
                    "criterion": "prostate intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Past medical history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug-induced interstitial lung disease",
                    "criterion": "drug-induced interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation pneumonitis which required steroid treatment",
                    "criterion": "radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroid"
                        }
                    ]
                },
                {
                    "exact_snippets": "any evidence of clinically active interstitial lung disease",
                    "criterion": "clinically active interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of peptic ulcer and/or gastrointestinal bleed",
            "criterions": [
                {
                    "exact_snippets": "History of peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... gastrointestinal bleed",
                    "criterion": "gastrointestinal bleed",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening",
            "criterions": [
                {
                    "exact_snippets": "History of stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 6 months prior to Screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 6 months prior to Screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 6 months prior to Screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia requiring medication or mechanical control",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": [
                                "medication",
                                "mechanical control"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 6 months prior to Screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the subject associated with his or her participation in the study.",
            "criterions": [
                {
                    "exact_snippets": "Unstable or severe uncontrolled medical condition (eg, unstable cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Unstable or severe uncontrolled medical condition (eg, ... unstable pulmonary condition including pneumonitis and/or interstitial lung disease",
                    "criterion": "pulmonary condition",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Unstable or severe uncontrolled medical condition (eg, ... uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the subject",
                    "criterion": "medical illness or abnormal laboratory finding",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "All subjects must meet the following criteria for inclusion:",
            "criterions": []
        },
        {
            "line": "* Both pleural and peritoneal mesothelioma are allowed",
            "criterions": [
                {
                    "exact_snippets": "pleural mesothelioma",
                    "criterion": "pleural mesothelioma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peritoneal mesothelioma",
                    "criterion": "peritoneal mesothelioma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients entering Part H must also meet the following additional criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Subjects are to be excluded from the study if they meet any of the following criteria:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}