{
    "info": {
        "nct_id": "NCT02769520",
        "official_title": "An Open-Label, Phase 2 Efficacy Study With Window of Opportunity Immune Assessment of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)",
        "inclusion_criteria": "* Has pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx) with evidence of local and/or locoregional recurrence. Laryngeal tumors will only be included if there is evidence of extralaryngeal spread, or there is associated nodal disease. For all other sites, superficial tumors can only be included if there is associated nodal disease.\n* Has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy.\n* Candidate for salvage resection.\n* Able to provide tissue from diagnostic core biopsy of tumor lesion(s).\n* Patient has adequate organ function.\n* Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication.\n* Female patient of childbearing potential agrees to use adequate birth control.\n* Male patient with a partner of childbearing potential agrees 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.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient has disease of nasopharyngeal carcinoma histology.\n* Patient has evidence of metastatic disease.\n* Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day 1.\n* Patient 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 pembrolizumab.\n* Patient has a known history of active TB (Bacillus Tuberculosis).\n* Patient has received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to a previously administered agents.\n* Patient has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study Day 1.\n* Patient 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* Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients 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* Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Notes: (1) Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded. (2) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Patient has a known history of, or any evidence of active, non-infectious pneumonitis.\n* Patient receives chronic steroid use > 10 mg prednisone (or steroid equivalent) daily.\n* Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.\n* Patient has received immunotherapy with inhibitors of PD-1 or PD-L1, or CTLA-4 blocking antibodies within 4 months prior to study Day 1.\n* Patient has known active Hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier (HIV 1/2 antibodies).\n* Patient has interstitial lung disease.\n* Patient is an appropriate candidate for adjuvant radiation after salvage therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Has pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx) with evidence of local and/or locoregional recurrence. Laryngeal tumors will only be included if there is evidence of extralaryngeal spread, or there is associated nodal disease. For all other sites, superficial tumors can only be included if there is associated nodal disease.",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx)",
                    "criterion": "SCCHN",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "larynx",
                                "hypopharynx"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of local and/or locoregional recurrence",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "local and/or locoregional"
                        }
                    ]
                },
                {
                    "exact_snippets": "Laryngeal tumors ... evidence of extralaryngeal spread",
                    "criterion": "laryngeal tumors",
                    "requirements": [
                        {
                            "requirement_type": "spread",
                            "expected_value": "extralaryngeal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Laryngeal tumors ... associated nodal disease",
                    "criterion": "laryngeal tumors",
                    "requirements": [
                        {
                            "requirement_type": "nodal disease",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial tumors ... associated nodal disease",
                    "criterion": "superficial tumors",
                    "requirements": [
                        {
                            "requirement_type": "nodal disease",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy.",
            "criterions": [
                {
                    "exact_snippets": "documented disease-free interval (minimum 16 weeks)",
                    "criterion": "disease-free interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Candidate for salvage resection.",
            "criterions": [
                {
                    "exact_snippets": "Candidate for salvage resection.",
                    "criterion": "salvage resection candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide tissue from diagnostic core biopsy of tumor lesion(s).",
            "criterions": [
                {
                    "exact_snippets": "Able to provide tissue from diagnostic core biopsy of tumor lesion(s).",
                    "criterion": "tissue from diagnostic core biopsy of tumor lesion(s)",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Female patient of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum or urine 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": "timing",
                            "expected_value": "within 72 hours prior to receiving the first dose of study medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patient of childbearing potential agrees to use adequate birth control.",
            "criterions": [
                {
                    "exact_snippets": "Female patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use adequate birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male patient with a partner of childbearing potential agrees 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 patient",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "partner of childbearing potential",
                    "criterion": "partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use an adequate method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "agrees to use"
                        }
                    ]
                },
                {
                    "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": "expected_value",
                            "expected_value": "starting with the first dose of study therapy through 120 days after the last dose of study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patient has disease of nasopharyngeal carcinoma histology.",
            "criterions": [
                {
                    "exact_snippets": "disease of nasopharyngeal carcinoma histology",
                    "criterion": "nasopharyngeal carcinoma histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has evidence of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Patient is currently receiving or has received another investigational agent",
                    "criterion": "investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to study Day 1",
                    "criterion": "time since last investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient 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 pembrolizumab.",
            "criterions": [
                {
                    "exact_snippets": "Patient has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is 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 pembrolizumab",
                    "criterion": "timeframe for therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to the first dose of pembrolizumab"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has a known history of active TB (Bacillus Tuberculosis).",
            "criterions": [
                {
                    "exact_snippets": "known history of active TB (Bacillus Tuberculosis)",
                    "criterion": "active TB (Bacillus Tuberculosis)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to a previously administered agents.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1",
                    "criterion": "prior anti-cancer monoclonal antibody (mAb)",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to a previously administered agents",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received prior ... 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": "Patient has received prior ... radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had major surgery",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "insufficient recovery from surgical-related trauma or wound healing",
                    "criterion": "recovery from surgical-related trauma or wound healing",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days from study Day 1",
                    "criterion": "time since surgery or trauma",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient 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": "Patient 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 or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "basal cell carcinoma of the skin or 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": "* Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients 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": "known active central nervous system (CNS) metastases",
                    "criterion": "active CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated brain metastases ... 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": "stable for at least four weeks"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated brain metastases ... any neurologic symptoms have returned to baseline",
                    "criterion": "neurologic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "returned to baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of new or enlarging brain metastases",
                    "criterion": "new or enlarging brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "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": "* Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Notes: (1) Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded. (2) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patient has an active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded",
                    "criterion": "vitiligo, Grave's disease, or psoriasis",
                    "requirements": [
                        {
                            "requirement_type": "systemic treatment requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy (e.g., 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
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has a known history of, or any evidence of active, non-infectious 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": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient receives chronic steroid use > 10 mg prednisone (or steroid equivalent) daily.",
            "criterions": [
                {
                    "exact_snippets": "chronic steroid use > 10 mg prednisone (or steroid equivalent) daily",
                    "criterion": "chronic steroid use",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone (or steroid equivalent) daily"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.",
            "criterions": [
                {
                    "exact_snippets": "Patient 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": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received immunotherapy with inhibitors of PD-1 or PD-L1, or CTLA-4 blocking antibodies within 4 months prior to study Day 1.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received immunotherapy with inhibitors of PD-1",
                    "criterion": "immunotherapy with inhibitors of PD-1",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received immunotherapy with ... PD-L1",
                    "criterion": "immunotherapy with inhibitors of PD-L1",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has received ... CTLA-4 blocking antibodies",
                    "criterion": "CTLA-4 blocking antibodies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has known active Hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier (HIV 1/2 antibodies).",
            "criterions": [
                {
                    "exact_snippets": "known active Hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA)",
                    "criterion": "Hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "HepB sAg",
                                "Hep B DNA"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C infection (defined as presence of Hep C RNA)",
                    "criterion": "Hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Hep C RNA"
                        }
                    ]
                },
                {
                    "exact_snippets": "known Human Immunodeficiency Virus (HIV) carrier (HIV 1/2 antibodies)",
                    "criterion": "HIV carrier",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "HIV 1/2 antibodies"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has interstitial lung disease.",
            "criterions": [
                {
                    "exact_snippets": "Patient has interstitial lung disease.",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is an appropriate candidate for adjuvant radiation after salvage therapy.",
            "criterions": [
                {
                    "exact_snippets": "appropriate candidate for adjuvant radiation",
                    "criterion": "adjuvant radiation candidacy",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after salvage therapy",
                    "criterion": "salvage therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}