{
    "info": {
        "nct_id": "NCT03463460",
        "official_title": "A Multicenter, Phase II Trial of Pembrolizumab and Sunitinib in Refractory Advanced Thymic Carcinoma",
        "inclusion_criteria": "* Be willing and able to provide written informed consent/assent for the trial\n* Have histologically or cytologically-documented diagnosis of advanced (metastatic and/or unresectable) thymic carcinoma, for which no curative treatment (including surgery, radiation, or other) is available\n* Have experienced progressive disease after at least one previous regimen of platinum-based chemotherapy. Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given for locally advanced disease is considered first line therapy only if recurrent (local or metastatic) disease developed within 6 months of completing therapy. Subjects with recurrent disease < 6 months will be eligible. Patients who have not had prior platinum-based chemotherapy for documented reasons (e.g., refusal or drug supply issues) may be eligible for study entry at the discretion of the sponsor investigator.\n* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block; a recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides [10 minimum] will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 3 years of trial screening; patients with tumor specimens older than 3 years may still be eligible if deemed so by study sponsor\n* Be willing to provide tissue from an on-treatment fine-needle aspiration (FNA) or core biopsy of a tumor lesion; subjects must consent to on-treatment biopsy prior to initiation of clinical trial, however in subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may still continue on study\n* Be willing to provide peripheral blood samples at screening and day 1 of cycle 2 and cycle 3 for correlative studies\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale\n* Life expectancy greater than 3 months\n* Ability to swallow and retain oral medication\n* No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart; the baseline systolic BP readings must be =< 140 mm Hg, and the baseline diastolic BP readings must be =< 90 mm Hg; use of antihypertensive medications to control BP is allowed\n* Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) >= 1,500 /mcL, performed within 28 days of treatment initiation\n* Platelets >= 100,000 / mcL, performed within 28 days of treatment initiation\n* Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN, performed within 28 days of treatment initiation\n* Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, performed within 28 days of treatment initiation\n* Albumin >= 2.5 mg/dL, performed within 28 days of treatment initiation\n* International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation\n* Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation\n* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\n\n  * Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject\n* Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\n\n  * Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Has received prior sunitinib or pembrolizumab therapy for the treatment of malignancy\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* Has a known history of active tuberculosis (TB) (Bacillus tuberculosis)\n* Hypersensitivity to pembrolizumab or sunitinib or any of their excipients\n* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: subjects with =< grade 2 neuropathy due to chemotherapy are an exception to this criterion and may qualify for the study\n  * Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy\n* Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Has active autoimmune disease, including myasthenic syndrome, which has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)\n* Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\n* Has received a live vaccine within 30 days of planned start of study therapy\n\n  * Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed\n* Significant proteinuria at baseline (> 500 mg/ 24 h, or > 2+ on spot analysis)\n* Serious non-healing wound, ulcer or bone fracture\n* Evidence of bleeding diathesis or coagulopathy\n* Grade >= 3 hemorrhage within 4 weeks of patient randomization\n* Recent (< 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction\n* Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE grade >= 2 or prolongation of the corrected QT interval (QTc) interval to > 500 msec\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors, including their administration within 10 days prior to patient treatment with study drug (eg, grapefruit juice or grapefruit/grapefruit-related citrus fruits [eg, Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, erythromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan); the topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed\n* Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, including their administration within 10 days prior to patient randomization, eg, phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, St John?s wort\n* Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Be willing and able to provide written informed consent/assent for the trial",
            "criterions": [
                {
                    "exact_snippets": "willing and able to provide written informed consent/assent",
                    "criterion": "informed consent/assent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have histologically or cytologically-documented diagnosis of advanced (metastatic and/or unresectable) thymic carcinoma, for which no curative treatment (including surgery, radiation, or other) is available",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically-documented diagnosis of advanced (metastatic and/or unresectable) thymic carcinoma",
                    "criterion": "thymic carcinoma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no curative treatment (including surgery, radiation, or other) is available",
                    "criterion": "curative treatment availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have experienced progressive disease after at least one previous regimen of platinum-based chemotherapy. Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given for locally advanced disease is considered first line therapy only if recurrent (local or metastatic) disease developed within 6 months of completing therapy. Subjects with recurrent disease < 6 months will be eligible. Patients who have not had prior platinum-based chemotherapy for documented reasons (e.g., refusal or drug supply issues) may be eligible for study entry at the discretion of the sponsor investigator.",
            "criterions": [
                {
                    "exact_snippets": "Have experienced progressive disease after at least one previous regimen of platinum-based chemotherapy.",
                    "criterion": "progressive disease after platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given for locally advanced disease is considered first line therapy only if recurrent (local or metastatic) disease developed within 6 months of completing therapy.",
                    "criterion": "recurrent disease within 6 months of completing platinum-containing therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with recurrent disease < 6 months will be eligible.",
                    "criterion": "recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "time since recurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have not had prior platinum-based chemotherapy for documented reasons (e.g., refusal or drug supply issues) may be eligible for study entry at the discretion of the sponsor investigator.",
                    "criterion": "no prior platinum-based chemotherapy for documented reasons",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "at the discretion of the sponsor investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
            "criterions": [
                {
                    "exact_snippets": "Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block; a recently obtained archival FFPE tumor tissue block (if an FFPE tissue block cannot be provided, 15 unstained slides [10 minimum] will be acceptable) from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 3 years of trial screening; patients with tumor specimens older than 3 years may still be eligible if deemed so by study sponsor",
            "criterions": [
                {
                    "exact_snippets": "Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block",
                    "criterion": "FFPE tumor tissue block",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a recently obtained archival FFPE tumor tissue block",
                    "criterion": "archival FFPE tumor tissue block",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if an FFPE tissue block cannot be provided, 15 unstained slides [10 minimum] will be acceptable",
                    "criterion": "unstained slides",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "slides"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "from a primary or metastatic tumor resection or biopsy",
                    "criterion": "tumor resection or biopsy",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": [
                                "primary",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "if it was obtained within 3 years of trial screening",
                    "criterion": "tumor specimen age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with tumor specimens older than 3 years may still be eligible if deemed so by study sponsor",
                    "criterion": "tumor specimen age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": "older than 3 years may be eligible if deemed so by study sponsor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be willing to provide tissue from an on-treatment fine-needle aspiration (FNA) or core biopsy of a tumor lesion; subjects must consent to on-treatment biopsy prior to initiation of clinical trial, however in subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may still continue on study",
            "criterions": [
                {
                    "exact_snippets": "willing to provide tissue from an on-treatment fine-needle aspiration (FNA) or core biopsy of a tumor lesion",
                    "criterion": "willingness to provide tissue",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects must consent to on-treatment biopsy prior to initiation of clinical trial",
                    "criterion": "consent to on-treatment biopsy",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale",
            "criterions": [
                {
                    "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy greater than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy greater than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to swallow and retain oral medication",
            "criterions": [
                {
                    "exact_snippets": "Ability to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "ability to retain oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart; the baseline systolic BP readings must be =< 140 mm Hg, and the baseline diastolic BP readings must be =< 90 mm Hg; use of antihypertensive medications to control BP is allowed",
            "criterions": [
                {
                    "exact_snippets": "No evidence of uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "2 baseline blood pressure (BP) readings taken at least 1 hour apart",
                    "criterion": "baseline blood pressure readings",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline systolic BP readings must be =< 140 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 140,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline diastolic BP readings must be =< 90 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "use of antihypertensive medications to control BP is allowed",
                    "criterion": "antihypertensive medication use",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO)",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN)",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "LLN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO)",
                    "criterion": "assessment method for LVEF",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "multigated acquisition (MUGA) scan",
                                "echocardiogram (ECHO)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >= 1,500 /mcL, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500 /mcL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "/mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "timing of ANC test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets >= 100,000 / mcL, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 100,000 / mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/ mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "timeframe for platelet count test",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =< 1.5 X upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured or calculated creatinine clearance ... >= 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine levels > 1.5 X institutional ULN",
                    "criterion": "creatinine levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "timeframe for test",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Serum total bilirubin =< 1.5 X ULN",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "direct bilirubin =< ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin levels > 1.5 ULN",
                    "criterion": "total bilirubin levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "timing of bilirubin test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ... =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level for subjects with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ... =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level for subjects with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin >= 2.5 mg/dL, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Albumin >= 2.5 mg/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio (INR) ... =< 1.5 X ULN",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time (PT) ... =< 1.5 X ULN",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "subject is receiving anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants",
                    "criterion": "PT or partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "therapeutic range",
                            "expected_value": "within"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "test timing",
                    "requirements": [
                        {
                            "requirement_type": "performed within",
                            "expected_value": "28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Activated partial thromboplastin time (aPTT) =< 1.5 X ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "subject is receiving anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PT or PTT is within therapeutic range of intended use of anticoagulants",
                    "criterion": "PT or PTT therapeutic range",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "therapeutic range of intended use of anticoagulants"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 28 days of treatment initiation",
                    "criterion": "test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required",
            "criterions": [
                {
                    "exact_snippets": "Female subject of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours prior to first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "female subjects of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "willingness to use contraception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate method of contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the course of the study through 120 days after the last dose of study medication",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through 120 days after the last dose of study medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject",
            "criterions": [
                {
                    "exact_snippets": "abstinence is acceptable if this is the usual lifestyle",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preferred contraception for the subject",
                    "criterion": "preferred contraception",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Male subjects of childbearing potential",
                    "criterion": "male subjects of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use an adequate method of contraception",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the first dose of study therapy through 120 days after the last dose of study therapy",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "starting with the first dose of study therapy through 120 days after the last dose of study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject",
            "criterions": [
                {
                    "exact_snippets": "abstinence is acceptable if this is the usual lifestyle",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "lifestyle",
                            "expected_value": "usual"
                        }
                    ]
                },
                {
                    "exact_snippets": "preferred contraception for the subject",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "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": "* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment",
            "criterions": [
                {
                    "exact_snippets": "currently participating and receiving study therapy",
                    "criterion": "current participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "receiving therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a study of an investigational agent and received study therapy",
                    "criterion": "past participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "receiving therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "used an investigational device within 4 weeks of the first dose of treatment",
                    "criterion": "use of investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior sunitinib or pembrolizumab therapy for the treatment of malignancy",
            "criterions": [
                {
                    "exact_snippets": "Has received prior sunitinib ... therapy for the treatment of malignancy",
                    "criterion": "sunitinib therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior ... pembrolizumab therapy for the treatment of malignancy",
                    "criterion": "pembrolizumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving ... any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to the first dose of trial treatment",
                    "criterion": "timeframe for therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of active tuberculosis (TB) (Bacillus tuberculosis)",
            "criterions": [
                {
                    "exact_snippets": "known history of active tuberculosis (TB)",
                    "criterion": "active tuberculosis history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to pembrolizumab or sunitinib or any of their excipients",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to pembrolizumab",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... sunitinib",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... any of their excipients",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent",
            "criterions": [
                {
                    "exact_snippets": "Has had prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted small molecule therapy",
                    "criterion": "prior targeted small molecule therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy within 2 weeks",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who has not recovered ... =< grade 1 or at baseline",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy",
            "criterions": [
                {
                    "exact_snippets": "subject received major surgery",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered adequately from the toxicity and/or complications from the intervention",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "adequate recovery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "Has a known additional malignancy that is progressing or requires active treatment",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "active treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions include basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions include ... squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exceptions include ... in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability",
            "criterions": [
                {
                    "exact_snippets": "Has known active central nervous system (CNS) metastases",
                    "criterion": "active CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis; ... carcinomatous meningitis which is excluded regardless of clinical stability",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment",
                    "criterion": "previously treated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "time since last progression",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any neurologic symptoms have returned to baseline",
                    "criterion": "neurologic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of new or enlarging brain metastases",
                    "criterion": "new or enlarging brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "are not using steroids for at least 7 days prior to trial treatment",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has active autoimmune disease, including myasthenic syndrome, which has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
            "criterions": [
                {
                    "exact_snippets": "Has active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myasthenic syndrome",
                    "criterion": "myasthenic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator",
            "criterions": [
                {
                    "exact_snippets": "Has a history or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has a history or current evidence of any ... therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has a history or current evidence of any ... laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "psychiatric or substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy with an anti-PD-1",
                    "criterion": "prior therapy with anti-PD-1 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-PD-L1",
                    "criterion": "prior therapy with anti-PD-L1 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-PD-L2",
                    "criterion": "prior therapy with anti-PD-L2 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)",
            "criterions": [
                {
                    "exact_snippets": "Has a known history of human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)",
            "criterions": [
                {
                    "exact_snippets": "known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive)",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known active ... hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received a live vaccine within 30 days of planned start of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Has received a live vaccine within 30 days of planned start of study therapy",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed",
            "criterions": [
                {
                    "exact_snippets": "seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed",
                    "criterion": "seasonal influenza vaccines for injection",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "inactivated"
                        }
                    ]
                },
                {
                    "exact_snippets": "intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed",
                    "criterion": "intranasal influenza vaccines",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "live attenuated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant proteinuria at baseline (> 500 mg/ 24 h, or > 2+ on spot analysis)",
            "criterions": [
                {
                    "exact_snippets": "Significant proteinuria at baseline (> 500 mg/ 24 h, or > 2+ on spot analysis)",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 500,
                                        "unit": "mg/24 h"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "+"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious non-healing wound, ulcer or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "Serious non-healing wound",
                    "criterion": "non-healing wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious ... ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious ... bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of bleeding diathesis or coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "Evidence of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of ... coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade >= 3 hemorrhage within 4 weeks of patient randomization",
            "criterions": [
                {
                    "exact_snippets": "Grade >= 3 hemorrhage within 4 weeks",
                    "criterion": "hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 4 weeks of patient randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent (< 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction",
            "criterions": [
                {
                    "exact_snippets": "Recent (< 6 months) arterial thromboembolic events, including transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Recent (< 6 months) arterial thromboembolic events, including ... cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Recent (< 6 months) arterial thromboembolic events, including ... unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Recent (< 6 months) arterial thromboembolic events, including ... myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors, including their administration within 10 days prior to patient treatment with study drug (eg, grapefruit juice or grapefruit/grapefruit-related citrus fruits [eg, Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, erythromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan); the topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed",
            "criterions": [
                {
                    "exact_snippets": "Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors",
                    "criterion": "use of strong CYP3A4/5 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "administration within 10 days prior to patient treatment with study drug",
                    "criterion": "administration of strong CYP3A4/5 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, including their administration within 10 days prior to patient randomization, eg, phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, St John?s wort",
            "criterions": [
                {
                    "exact_snippets": "Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers",
                    "criterion": "use of strong CYP3A4/5 inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including their administration within 10 days prior to patient randomization",
                    "criterion": "administration of strong CYP3A4/5 inducers within 10 days prior to randomization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug",
            "criterions": [
                {
                    "exact_snippets": "Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug",
                    "criterion": "suitability to receive study drug",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator's opinion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Be willing to provide peripheral blood samples at screening and day 1 of cycle 2 and cycle 3 for correlative studies",
            "criterions": [
                {
                    "exact_snippets": "willing to provide peripheral blood samples",
                    "criterion": "willingness to provide peripheral blood samples",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral blood samples at screening",
                    "criterion": "peripheral blood samples at screening",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral blood samples ... day 1 of cycle 2",
                    "criterion": "peripheral blood samples at day 1 of cycle 2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral blood samples ... day 1 of cycle 3",
                    "criterion": "peripheral blood samples at day 1 of cycle 3",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Note: subjects with =< grade 2 neuropathy due to chemotherapy are an exception to this criterion and may qualify for the study",
            "criterions": [
                {
                    "exact_snippets": "= < grade 2 neuropathy due to chemotherapy",
                    "criterion": "neuropathy due to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE grade >= 2 or prolongation of the corrected QT interval (QTc) interval to > 500 msec",
            "criterions": [
                {
                    "exact_snippets": "Ongoing cardiac dysrhythmias ... NCI CTCAE grade >= 2",
                    "criterion": "cardiac dysrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prolongation of the corrected QT interval (QTc) interval to > 500 msec",
                    "criterion": "corrected QT interval (QTc)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 500,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}