{
    "info": {
        "nct_id": "NCT06525220",
        "official_title": "A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma",
        "inclusion_criteria": "1. Signed ICF before initiation of any study procedures\n2. Age ≥ 18 years at signing of ICF\n3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.\n4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.\n6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting\n7. A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.\n8. Measurable disease as defined by RECIST v1.1 by radiologic methods.\n9. ECOG Performance Status (PS) of 0-1\n10. Life expectancy ≥ 12 weeks, as per investigator assessment.\n11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n12. Adequate organ function as defined per protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days of study entry.\n2. Known leptomeningeal involvement\n3. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment\n4. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment\n5. Persistent Grade >1 clinically significant toxicities related to prior cancer therapies (except for alopecia); stable sensory neuropathy Grade ≤2 National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is allowed.\n6. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.\n7. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or history of myocardial infarction within 6 months of study entry\n8. History of prior malignancies, with the exception of excised local cancer, or treated cancer deemed at low risk for recurrence with no evidence of disease for ≥3 years\n9. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy\n10. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders\n11. Patients with known infectious diseases as per protocol.\n12. Pregnant or breastfeeding patients.\n13. The patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose\n14. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment.\n15. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)\n\nOther protocol defined inclusion/exclusion criteria may apply.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Signed ICF before initiation of any study procedures",
            "criterions": [
                {
                    "exact_snippets": "Signed ICF",
                    "criterion": "informed consent form (ICF)",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ≥ 18 years at signing of ICF",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed HNSCC",
                    "criterion": "HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of metastatic or locally recurrent disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "metastatic",
                                "locally recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to local therapy with curative intent",
                    "criterion": "amenability to local therapy",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.",
            "criterions": [
                {
                    "exact_snippets": "HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.",
                    "criterion": "HNSCC primary tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "oropharynx",
                                "oral cavity",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.",
            "criterions": [
                {
                    "exact_snippets": "HNSCC patients",
                    "criterion": "HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible to receive pembrolizumab as 1L monotherapy",
                    "criterion": "pembrolizumab eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors expressing PD-L1",
                    "criterion": "PD-L1 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CPS ≥1",
                    "criterion": "CPS",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting",
                    "criterion": "previous systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.",
            "criterions": [
                {
                    "exact_snippets": "baseline new tumor sample",
                    "criterion": "baseline new tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "available tumor sample as an FFPE block",
                    "criterion": "available tumor sample as an FFPE block",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient material",
                    "criterion": "sufficient material",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "sufficient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Measurable disease as defined by RECIST v1.1 by radiologic methods.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as defined by RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "by radiologic methods",
                    "criterion": "radiologic methods",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. ECOG Performance Status (PS) of 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status (PS) of 0-1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Life expectancy ≥ 12 weeks, as per investigator assessment.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "institutional normal limit"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "by echocardiogram (ECHO) or multigated acquisition (MUGA) scan",
                    "criterion": "method of measurement for LVEF",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "echocardiogram (ECHO)",
                                "multigated acquisition (MUGA) scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Adequate organ function as defined per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined per protocol"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "symptom status",
                            "expected_value": "symptomatic"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": [
                                "radiation",
                                "surgery",
                                "continued steroid therapy"
                            ]
                        },
                        {
                            "requirement_type": "treatment timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Known leptomeningeal involvement",
            "criterions": [
                {
                    "exact_snippets": "Known leptomeningeal involvement",
                    "criterion": "leptomeningeal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "systemic anticancer therapy within 4 weeks of the first dose of study treatment",
                    "criterion": "systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery ... within 3 weeks of the first dose of study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy within 3 weeks of the first dose of study treatment",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Persistent Grade >1 clinically significant toxicities related to prior cancer therapies (except for alopecia); stable sensory neuropathy Grade ≤2 National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Persistent Grade >1 clinically significant toxicities related to prior cancer therapies (except for alopecia)",
                    "criterion": "clinically significant toxicities related to prior cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "alopecia"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stable sensory neuropathy Grade ≤2 National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is allowed",
                    "criterion": "stable sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity reaction to any of the excipients of petosemtomab",
                    "criterion": "hypersensitivity reaction to excipients of petosemtomab",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity reaction to any of the excipients of ... pembrolizumab",
                    "criterion": "hypersensitivity reaction to excipients of pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or history of myocardial infarction within 6 months of study entry",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "Class"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Class"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious cardiac arrhythmia requiring treatment",
                    "criterion": "serious cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of myocardial infarction within 6 months of study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of prior malignancies, with the exception of excised local cancer, or treated cancer deemed at low risk for recurrence with no evidence of disease for ≥3 years",
            "criterions": [
                {
                    "exact_snippets": "History of prior malignancies",
                    "criterion": "prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excised local cancer",
                    "criterion": "excised local cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated cancer deemed at low risk for recurrence",
                    "criterion": "treated cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence risk",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of disease for ≥3 years",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy",
            "criterions": [
                {
                    "exact_snippets": "Current dyspnea at rest of any origin",
                    "criterion": "dyspnea at rest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other diseases requiring continuous oxygen therapy",
                    "criterion": "diseases requiring continuous oxygen therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders",
            "criterions": [
                {
                    "exact_snippets": "Current serious illness or medical conditions",
                    "criterion": "serious illness or medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant pulmonary ... disorders",
                    "criterion": "pulmonary disorders",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ... metabolic ... disorders",
                    "criterion": "metabolic disorders",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ... psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with known infectious diseases as per protocol.",
            "criterions": [
                {
                    "exact_snippets": "known infectious diseases",
                    "criterion": "infectious diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Pregnant or breastfeeding patients.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. The patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose",
            "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 form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment.",
            "criterions": [
                {
                    "exact_snippets": "The patient has an active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required systemic immune suppressive treatment in the past 2 years",
                    "criterion": "systemic immune suppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)",
            "criterions": [
                {
                    "exact_snippets": "primary tumor site of nasopharynx",
                    "criterion": "primary tumor site",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "nasopharynx"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary tumor site of ... sinonasal carcinoma",
                    "criterion": "primary tumor site",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "sinonasal carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "sinonasal carcinoma (any histology)",
                    "criterion": "sinonasal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "histology",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other protocol defined inclusion/exclusion criteria may apply.",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined inclusion/exclusion criteria",
                    "criterion": "protocol defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}