{
    "info": {
        "nct_id": "NCT02690948",
        "official_title": "A Phase 1b Open Label Study of Pembrolizumab for Unresectable or Metastatic Basal Cell Carcinoma",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "INCLUSION CRITERIA\n\n* Histologically-proven basal cell carcinoma (BCC) in which curative resection is unlikely without significant morbidity, or have nodal or distantly metastatic disease which has progressed on vismodegib (Arm 1) or has achieved partial response or stable disease on smoothened inhibitor (Arm 2). Individuals who are intolerant or have a medical contra-indication to smoothened inhibitor will be enrolled into Arm 1.\n* Have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1\n* ≥ 18 years of age on day of consent.\n* Willing to provide tissue from a core or excisional biopsy of a tumor lesion up to 6 weeks (42 days) prior to initiation of treatment on Day 1, or availability of adequate archival specimens.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1\n* Absolute neutrophil count (ANC) ≥ 1,500/mcL\n* Platelets ≥ 100,000/mcL\n* Hemoglobin ≥ 9 g/dL, or ≥ 5.6 mmol/L, without transfusion or EPO dependency (within 7 days of assessment)\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for subject(s) with creatinine levels > 1.5 x ULN\n* Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN, OR ≤ 5 x ULN for subjects with liver metastases\n* alanine aminotransferase (ALT) ≤ 2.5 x ULN, OR ≤ 5 x ULN for subjects with liver metastases\n* Albumin ≥ 2.5 mg/dL\n* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, in which case PT/INR must be within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, in which case PTT must be within therapeutic range of intended use of anticoagulants\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 should be willing to use 2 methods of birth control or be surgically sterile, or be willing to abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.\n* If female, is postmenopausal; is surgically sterile; or agrees to use 2 acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment\n* If female, 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* Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw.\n* Willing and able to provide written informed consent/assent for the trial. Consent may be obtained by legally-authorized representative (LAR).\n\nEXCLUSION CRITERIA\n\n* Currently receiving investigational study therapy, or has received investigational study therapy, or used an investigational device, within 4 weeks of the first dose of treatment.\n* 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 (EXCEPTIONS: topical, intraarticular, intralesional, and inhaled steroids)\n* Known history of active Bacillus Tuberculosis (TB) infection\n* Hypersensitivity to pembrolizumab or any of its excipients.\n* Has received an anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1, or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. (EXCEPTION: Subjects with ≤ Grade 2 neuropathy may qualify for the study).\n* If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.\n* Known additional malignancy that is progressing or requires active treatment. (EXCEPTIONS: 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* Carcinomatous meningitis without consideration of clinical stability\n* 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.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (ie, 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. Intraarticular, inhaled, and intralesional doses of steroids are allowed at screening and during the study.\n* Known history of, or any evidence of active, non-infectious pneumonitis that required steroids or current pneumonitis.\n* Active infection requiring systemic therapy.\n* 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\n* 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 (eg, HBsAg reactive) or Hepatitis C (eg, HCV RNA [qualitative] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist) are live attenuated vaccines, and are not allowed."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically-proven basal cell carcinoma (BCC) in which curative resection is unlikely without significant morbidity, or have nodal or distantly metastatic disease which has progressed on vismodegib (Arm 1) or has achieved partial response or stable disease on smoothened inhibitor (Arm 2). Individuals who are intolerant or have a medical contra-indication to smoothened inhibitor will be enrolled into Arm 1.",
            "criterions": [
                {
                    "exact_snippets": "Histologically-proven basal cell carcinoma (BCC)",
                    "criterion": "basal cell carcinoma (BCC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "curative resection is unlikely without significant morbidity",
                    "criterion": "curative resection",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "unlikely without significant morbidity"
                        }
                    ]
                },
                {
                    "exact_snippets": "nodal or distantly metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "nodal",
                                "distant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease which has progressed on vismodegib",
                    "criterion": "disease progression on vismodegib",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "achieved partial response or stable disease on smoothened inhibitor",
                    "criterion": "response to smoothened inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "partial response",
                                "stable disease"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant or have a medical contra-indication to smoothened inhibitor",
                    "criterion": "tolerance to smoothened inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1",
            "criterions": [
                {
                    "exact_snippets": "measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 18 years of age on day of consent.",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to provide tissue from a core or excisional biopsy of a tumor lesion up to 6 weeks (42 days) prior to initiation of treatment on Day 1, or availability of adequate archival specimens.",
            "criterions": [
                {
                    "exact_snippets": "Willing to provide tissue from a core or excisional biopsy of a tumor lesion",
                    "criterion": "willingness to provide tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "up to 6 weeks (42 days) prior to initiation of treatment on Day 1",
                    "criterion": "timing of biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "availability of adequate archival specimens",
                    "criterion": "availability of archival specimens",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1,500/mcL",
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9 g/dL, or ≥ 5.6 mmol/L, without transfusion or EPO dependency (within 7 days of assessment)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ... ≥ 5.6 mmol/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5.6,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without transfusion",
                    "criterion": "transfusion dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... EPO dependency",
                    "criterion": "EPO dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for subject(s) with creatinine levels > 1.5 x ULN",
            "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 ULN",
                    "criterion": "creatinine levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN",
            "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 for subjects with total bilirubin levels > 1.5 x ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) ≤ 2.5 x ULN, OR ≤ 5 x ULN for subjects with liver metastases",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ≤ 2.5 x ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 5 x ULN for subjects with liver metastases",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "liver metastases"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* alanine aminotransferase (ALT) ≤ 2.5 x ULN, OR ≤ 5 x ULN for subjects with liver metastases",
            "criterions": [
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ≤ 2.5 x ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... ≤ 5 x ULN for subjects with liver metastases",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "subjects with liver metastases"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin ≥ 2.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin ≥ 2.5 mg/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, in which case PT/INR must be within therapeutic range of intended use of anticoagulants",
            "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 ... PT/INR must be within therapeutic range of intended use of anticoagulants",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "PT/INR therapeutic range",
                            "expected_value": "within therapeutic range of intended use of anticoagulants"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, in which case PTT must be within therapeutic range of intended use of anticoagulants",
            "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": "PTT must be within therapeutic range of intended use of anticoagulants",
                    "criterion": "PTT",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "therapeutic range of intended use of anticoagulants"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 72 hours prior to receiving the first dose of study medication",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 72 hours prior to first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or be willing to abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use 2 methods of birth control",
                    "criterion": "birth control methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "be surgically sterile",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to abstain from heterosexual activity",
                    "criterion": "abstinence from heterosexual activity",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the course of the study through 120 days after the last dose of study medication",
                    "criterion": "duration of birth control or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through 120 days after the last dose of study medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year",
                    "criterion": "definition of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "surgical sterilization",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "menses",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female, 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": "If female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to use an adequate method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the first dose of study therapy through 120 days after the last dose of study therapy",
                    "criterion": "contraception duration",
                    "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": "* Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw.",
            "criterions": [
                {
                    "exact_snippets": "Male with female partner of childbearing potential",
                    "criterion": "male with female partner of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout study, until 120 days after last dose of treatment or last blood draw"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to provide written informed consent/assent for the trial. Consent may be obtained by legally-authorized representative (LAR).",
            "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
                        }
                    ]
                },
                {
                    "exact_snippets": "Consent may be obtained by legally-authorized representative (LAR)",
                    "criterion": "consent by legally-authorized representative",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving investigational study therapy, or has received investigational study therapy, or used an investigational device, within 4 weeks of the first dose of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving investigational study therapy",
                    "criterion": "investigational study therapy",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": "receiving"
                        }
                    ]
                },
                {
                    "exact_snippets": "has received investigational study therapy",
                    "criterion": "investigational study therapy",
                    "requirements": [
                        {
                            "requirement_type": "past status",
                            "expected_value": "received"
                        }
                    ]
                },
                {
                    "exact_snippets": "used an investigational device",
                    "criterion": "investigational device",
                    "requirements": [
                        {
                            "requirement_type": "past status",
                            "expected_value": "used"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks of the first dose of treatment",
                    "criterion": "time since last investigational therapy or device use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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 (EXCEPTIONS: topical, intraarticular, intralesional, and inhaled steroids)",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving ... any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "* Known history of active Bacillus Tuberculosis (TB) infection",
            "criterions": [
                {
                    "exact_snippets": "Known history of active Bacillus Tuberculosis (TB) infection",
                    "criterion": "Bacillus Tuberculosis (TB) infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to pembrolizumab or any of its excipients.",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to pembrolizumab",
                    "criterion": "hypersensitivity to pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... any of its excipients",
                    "criterion": "hypersensitivity to pembrolizumab excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received an anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1, or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.",
            "criterions": [
                {
                    "exact_snippets": "Has received an anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1",
                    "criterion": "anti-cancer monoclonal antibody (mAb) administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. (EXCEPTION: Subjects with ≤ Grade 2 neuropathy may qualify for the study).",
            "criterions": [
                {
                    "exact_snippets": "Has received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1",
                    "criterion": "recent treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with ≤ Grade 2 neuropathy may qualify for the study",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "receipt",
                            "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": "* Known additional malignancy that is progressing or requires active treatment. (EXCEPTIONS: 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": "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": "basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "basal cell carcinoma or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carcinomatous meningitis without consideration of clinical stability",
            "criterions": [
                {
                    "exact_snippets": "Carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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.",
            "criterions": [
                {
                    "exact_snippets": "Known active central nervous system (CNS) metastases",
                    "criterion": "active CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with previously treated brain metastases may participate provided they are stable",
                    "criterion": "stability of previously treated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment",
                    "criterion": "progression of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0,
                                "unit": "evidence of progression"
                            }
                        }
                    ]
                },
                {
                    "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": "not using steroids for at least 7 days prior to trial treatment",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease that has required systemic treatment in the past 2 years (ie, 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. Intraarticular, inhaled, and intralesional doses of steroids are allowed at screening and during the study.",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease that has required systemic treatment in the past 2 years",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration as systemic treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Intraarticular, inhaled, and intralesional doses of steroids are allowed at screening and during the study",
                    "criterion": "steroid administration route",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": [
                                "intraarticular",
                                "inhaled",
                                "intralesional"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of, or any evidence of active, non-infectious pneumonitis that required steroids or current pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "Known history of, or any evidence of active, non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that required steroids",
                    "criterion": "steroid requirement for pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis",
                    "criterion": "current pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "* 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": "History or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "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 disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is pregnant or breastfeeding",
            "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
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "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.",
                    "criterion": "expectation to conceive or father children",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "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"
                        }
                    ]
                }
            ]
        },
        {
            "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": "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 (eg, HBsAg reactive) or Hepatitis C (eg, HCV RNA [qualitative] is detected).",
            "criterions": [
                {
                    "exact_snippets": "Has known active Hepatitis B (eg, HBsAg reactive)",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has known active ... Hepatitis C (eg, HCV RNA [qualitative] is detected)",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist) are live attenuated vaccines, and are not allowed.",
            "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"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed",
                    "criterion": "seasonal influenza vaccines for injection",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intranasal influenza vaccines (eg, Flu-Mist) are live attenuated vaccines, and are not allowed",
                    "criterion": "intranasal influenza vaccines",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "INCLUSION CRITERIA",
            "criterions": []
        },
        {
            "line": "* If female, is postmenopausal; is surgically sterile; or agrees to use 2 acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment",
            "criterions": [
                {
                    "exact_snippets": "If female, is postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "If female, is surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "surgically sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "If female, ... agrees to use 2 acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "methods",
                            "expected_value": ">= 2"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the trial, until 120 days after the last dose of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "EXCLUSION CRITERIA",
            "criterions": []
        }
    ]
}