{
    "info": {
        "nct_id": "NCT03013491",
        "official_title": "An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas",
        "inclusion_criteria": "1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy\n2. Agreement to provide mandatory archival tissue or fresh biopsy.\n3. At least 18 years of age.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.\n2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.\n3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.\n4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.\n5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.\n6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.\n7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.\n8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or advanced unresectable tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "advanced unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors that progressed on standard therapy",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressed on standard therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Agreement to provide mandatory archival tissue or fresh biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Agreement to provide mandatory archival tissue or fresh biopsy.",
                    "criterion": "archival tissue or fresh biopsy",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. At least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "chimeric antigen receptor (CAR) T-cell containing regimen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.",
            "criterions": [
                {
                    "exact_snippets": "History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy",
                    "criterion": "severe allergic or anaphylactic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": "human monoclonal antibody therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to any Probody therapeutic",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "Probody therapeutic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.",
            "criterions": [
                {
                    "exact_snippets": "Active or history of uveal, mucosal, or ocular melanoma.",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "uveal",
                                "mucosal",
                                "ocular"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "history"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired immune deficiency syndrome (AIDS)-related illness",
                    "criterion": "AIDS-related illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic hepatitis B or C",
                    "criterion": "chronic hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.",
            "criterions": [
                {
                    "exact_snippets": "History of or current active autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel diseases",
                    "criterion": "inflammatory bowel diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune thyroiditis",
                    "criterion": "autoimmune thyroiditis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune hepatitis",
                    "criterion": "autoimmune hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic sclerosis",
                    "criterion": "systemic sclerosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune vasculitis",
                    "criterion": "autoimmune vasculitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune neuropathies",
                    "criterion": "autoimmune neuropathies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "type 1 insulin dependent diabetes mellitus",
                    "criterion": "type 1 insulin dependent diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.",
            "criterions": [
                {
                    "exact_snippets": "History of syndrome or medical condition(s) that requires systemic steroids",
                    "criterion": "syndrome or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "systemic steroids"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic steroids (> 10 mg daily prednisone equivalents)",
                    "criterion": "systemic steroid dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalents"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of syndrome or medical condition(s) that requires ... immunosuppressive medications",
                    "criterion": "syndrome or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "immunosuppressive medications"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.",
            "criterions": [
                {
                    "exact_snippets": "History of allogeneic tissue/solid organ transplant",
                    "criterion": "allogeneic tissue/solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior stem cell or bone marrow transplant",
                    "criterion": "stem cell or bone marrow transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "chemotherapy",
                                "biochemotherapy",
                                "radiation",
                                "immunotherapy",
                                "investigational treatment"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery (requiring general anesthesia) within 3 months",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "minor surgery (excluding biopsies conducted with local/topical anesthesia) ... within 14 days",
                    "criterion": "minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "gamma knife treatment within 14 days",
                    "criterion": "gamma knife treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}