{
    "info": {
        "nct_id": "NCT06099782",
        "official_title": "A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)",
        "inclusion_criteria": "* Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type:\n\n  * Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition.\n  * Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status.\n  * Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy.\n* Has a life expectancy of at least 3 months.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before the start of study intervention.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.\n* Melanoma participants with ocular, mucosal, or conjunctival melanoma.\n* Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization.\n* Has received prior radiotherapy for RCC.\n* RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava.\n* Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.\n* Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n* Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n* Has active infection requiring systemic therapy.\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Has history of allogeneic tissue/solid organ transplant corticosteroids.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.\n* Has not adequately recovered from major surgery or have ongoing surgical complications.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type:",
            "criterions": [
                {
                    "exact_snippets": "histologically- or cytologically-confirmed",
                    "criterion": "tumor confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "early stage or advanced/ metastatic solid tumor",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "early stage",
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition.",
            "criterions": [
                {
                    "exact_snippets": "Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma",
                    "criterion": "cutaneous melanoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIB",
                                "IIC",
                                "III"
                            ]
                        },
                        {
                            "requirement_type": "surgical resection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "per American Joint Committee on Cancer (AJCC) eighth edition",
                    "criterion": "AJCC edition",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "eighth"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status.",
            "criterions": [
                {
                    "exact_snippets": "Surgically resected renal cell carcinoma (RCC)",
                    "criterion": "renal cell carcinoma (RCC)",
                    "requirements": [
                        {
                            "requirement_type": "surgical resection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intermediate-high or high risk of recurrence",
                    "criterion": "risk of recurrence",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "intermediate-high",
                                "high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as defined by the Fuhrman grading status",
                    "criterion": "Fuhrman grading status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "risk of recurrence"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy.",
            "criterions": [
                {
                    "exact_snippets": "Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "classification",
                            "expected_value": "AJCC eight edition"
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%",
                    "criterion": "PD-L1 tumor proportion score (TPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy",
                    "criterion": "EGFR, ALK, or ROS1 directed therapy",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)-infected participants",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "well controlled HIV on antiretroviral therapy (ART)",
                    "criterion": "HIV control",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "well controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.",
            "criterions": [
                {
                    "exact_snippets": "hepatitis B surface antigen (HBsAg) positive",
                    "criterion": "hepatitis B surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks",
                    "criterion": "hepatitis B virus (HBV) antiviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable HBV viral load before randomization",
                    "criterion": "HBV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with history of hepatitis C virus (HCV) infection are eligible if have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening.",
            "criterions": [
                {
                    "exact_snippets": "history of hepatitis C virus (HCV) infection",
                    "criterion": "history of hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "completed curative antiviral therapy at least 4 weeks before randomization",
                    "criterion": "curative antiviral therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV viral load is undetectable at screening",
                    "criterion": "HCV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before the start of study intervention.",
            "criterions": [
                {
                    "exact_snippets": "Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "assessed within 3 days before the start of study intervention",
                    "criterion": "assessment timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 3 days before the start of study intervention"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.",
            "criterions": [
                {
                    "exact_snippets": "Non-small cell lung cancer (NSCLC) participants",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosis of small cell lung cancer",
                    "criterion": "small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mixed tumors, presence of small cell elements",
                    "criterion": "small cell elements in mixed tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Melanoma participants with ocular, mucosal, or conjunctival melanoma.",
            "criterions": [
                {
                    "exact_snippets": "Melanoma participants",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ocular, mucosal, or conjunctival melanoma",
                    "criterion": "melanoma subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "ocular",
                                "mucosal",
                                "conjunctival"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization.",
            "criterions": [
                {
                    "exact_snippets": "Renal Cell Carcinoma (RCC) participants",
                    "criterion": "Renal Cell Carcinoma (RCC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "other than nephrectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior radiotherapy for RCC.",
            "criterions": [
                {
                    "exact_snippets": "Has received prior radiotherapy for RCC.",
                    "criterion": "prior radiotherapy for RCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava.",
            "criterions": [
                {
                    "exact_snippets": "RCC participants",
                    "criterion": "RCC (Renal Cell Carcinoma)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "residual thrombus",
                    "criterion": "residual thrombus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "post nephrectomy",
                    "criterion": "post nephrectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post-surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "vena renalis or vena cava",
                    "criterion": "location of thrombus",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "vena renalis",
                                "vena cava"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy with an anti-programmed cell death 1 protein (PD-1)",
                    "criterion": "prior therapy with anti-PD-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... PD-L1",
                    "criterion": "prior therapy with PD-L1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-PD-L2 agent",
                    "criterion": "prior therapy with anti-PD-L2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... agent directed to another stimulatory or coinhibitory T-cell receptor",
                    "criterion": "prior therapy with agent directed to another T-cell receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)",
                    "criterion": "prior therapy with CTLA-4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... OX-40",
                    "criterion": "prior therapy with OX-40",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... CD137",
                    "criterion": "prior therapy with CD137",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.",
            "criterions": [
                {
                    "exact_snippets": "Has received prior systemic anticancer therapy including investigational agents",
                    "criterion": "prior systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks before randomization",
                    "criterion": "time since last systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.",
                    "criterion": "live or live-attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Administration of killed vaccines is allowed.",
                    "criterion": "killed vaccines",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Received prior radiotherapy within 2 weeks of start of study intervention",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation-related toxicities",
                    "criterion": "radiation-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring corticosteroids",
                    "criterion": "corticosteroid requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Received prior systemic anticancer therapy for their metastatic NSCLC.",
                    "criterion": "prior systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed ... therapy was completed at least 12 months before diagnosis of metastatic NSCLC.",
                    "criterion": "prior neoadjuvant or adjuvant therapy for nonmetastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": "<=",
                                "value": -12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.",
            "criterions": [
                {
                    "exact_snippets": "Received radiation therapy to the lung",
                    "criterion": "radiation therapy to the lung",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy to the lung that is >30 Gray",
                    "criterion": "radiation therapy dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "Gray"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months of start of study intervention",
                    "criterion": "time since radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.",
            "criterions": [
                {
                    "exact_snippets": "Has received an investigational agent",
                    "criterion": "investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has used an investigational device",
                    "criterion": "investigational device",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to study intervention administration",
                    "criterion": "time since last investigational agent/device usage",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Has diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving chronic systemic steroid therapy",
                    "criterion": "chronic 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 the first dose of study medication",
                    "criterion": "timeframe for therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to the first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.",
            "criterions": [
                {
                    "exact_snippets": "known additional malignancy",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known additional malignancy ... has required active treatment within the past 3 years",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "known active central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has active autoimmune disease that has required systemic treatment in the past 2 years.",
            "criterions": [
                {
                    "exact_snippets": "Has active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.",
            "criterions": [
                {
                    "exact_snippets": "history of (noninfectious) pneumonitis/interstitial lung disease that required steroids",
                    "criterion": "history of noninfectious pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "required steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis/interstitial lung disease",
                    "criterion": "current pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has active infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.",
            "criterions": [
                {
                    "exact_snippets": "HIV-infected participants",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of Kaposi's sarcoma",
                    "criterion": "Kaposi's sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Multicentric Castleman's Disease",
                    "criterion": "Multicentric Castleman's Disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has history of allogeneic tissue/solid organ transplant corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Has history of allogeneic tissue/solid organ transplant",
                    "criterion": "history of allogeneic tissue/solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.",
            "criterions": [
                {
                    "exact_snippets": "severe hypersensitivity (≥Grade 3) to pembrolizumab",
                    "criterion": "hypersensitivity to pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hypersensitivity (≥Grade 3) to ... any of its excipients",
                    "criterion": "hypersensitivity to pembrolizumab excipients",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has not adequately recovered from major surgery or have ongoing surgical complications.",
            "criterions": [
                {
                    "exact_snippets": "Has not adequately recovered from major surgery",
                    "criterion": "recovery from major surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not adequately recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "have ongoing surgical complications",
                    "criterion": "surgical complications",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}