{
    "info": {
        "nct_id": "NCT03771820",
        "official_title": "Phase IIa/IIb Clinical Trial of NC-6004 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed Platinum or a Platinum-containing Regimen",
        "inclusion_criteria": "* Be willing and able to provide written informed consent for the trial.\n* Males or females aged ≥18 years at screening.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Have histologically- or cytologically-confirmed HNSCC.\n* Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.\n* Having prior platinum failure.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies.\n* Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.\n* Have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.\n* Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.\n* Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Be willing and able to provide written informed consent for the trial.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males or females aged ≥18 years at screening.",
            "criterions": [
                {
                    "exact_snippets": "Males or females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have histologically- or cytologically-confirmed HNSCC.",
            "criterions": [
                {
                    "exact_snippets": "histologically- or cytologically-confirmed HNSCC",
                    "criterion": "HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.",
            "criterions": [
                {
                    "exact_snippets": "recurrent disease not amenable to curative treatment with local or systemic therapy",
                    "criterion": "recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "amenability to curative treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx",
                    "criterion": "metastatic HNSCC",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "considered incurable by local therapies",
                    "criterion": "incurability by local therapies",
                    "requirements": [
                        {
                            "requirement_type": "incurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having prior platinum failure.",
            "criterions": [
                {
                    "exact_snippets": "prior platinum failure",
                    "criterion": "platinum-based therapy",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies.",
            "criterions": [
                {
                    "exact_snippets": "carcinoma of the nasopharynx",
                    "criterion": "carcinoma of the nasopharynx",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma of unknown primary origination",
                    "criterion": "squamous cell carcinoma of unknown primary origination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma that originates from the skin",
                    "criterion": "squamous cell carcinoma originating from the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma that originates from the ... salivary gland",
                    "criterion": "squamous cell carcinoma originating from the salivary gland",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma that originates from the ... paranasal sinus",
                    "criterion": "squamous cell carcinoma originating from the paranasal sinus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "nonsquamous histologies",
                    "criterion": "nonsquamous histologies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.",
            "criterions": [
                {
                    "exact_snippets": "disease that is suitable for locoregional treatment",
                    "criterion": "disease suitability for locoregional treatment",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refuses curative intent",
                    "criterion": "refusal of curative intent",
                    "requirements": [
                        {
                            "requirement_type": "refusal",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.",
            "criterions": [
                {
                    "exact_snippets": "no more than 15% body weight loss ... in the last 3 months",
                    "criterion": "body weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "%"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "currently participating in or have participated in a study of an investigational agent",
                    "criterion": "participation in a study of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "using an investigational device within 4 weeks prior to the first dose of trial treatment",
                    "criterion": "use of an investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "previously treated with 3 or more lines of systemic therapies",
                    "criterion": "systemic therapies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "administered for recurrent and/or metastatic disease",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}