{
    "info": {
        "nct_id": "NCT03495882",
        "official_title": "A Phase 1 / 2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination With AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors",
        "inclusion_criteria": "To be eligible for participation in this trial the subject must:\n\n1. Voluntarily agree to participate by giving written informed consent. (Participation in pharmacogenomics testing is optional.)\n2. Be ≥18 years of age.\n3. Diagnosis:\n\n   1. Phase 1: Male or female having a histologically or cytologically confirmed diagnosis of a locally advanced, recurrent, and/or metastatic solid tumor for which no standard therapy is available or standard therapy has failed.\n   2. Phase 2:\n\n   I. Female having (1) a histologically or cytologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) locally advanced, recurrent, and/or metastatic disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.\n\n   Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.\n\n   II. Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for locally advanced, recurrent, and/or metastatic disease; Note: Subjects who only received platinum-based chemotherapy concurrently with primary radiation (e.g., weekly cisplatin) or adjuvant chemotherapy following completion of radiation therapy (e.g., paclitaxel and carboplatin for ≤4 cycles) and progressed within 6 months after treatment completion will be eligible as this systemic therapy will be considered first line.\n4. Measurable Disease:\n\n   1. Phase 1: Have objective evidence of disease; the presence of measurable disease is not required.\n   2. Phase 2: Have measurable disease on imaging based on RECIST version 1.1. Note: Subjects must have at least one \"target lesion\" to be used to assess response, as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\n\n   Note: Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review prior to first dose. Subjects without centrally confirmed measurable disease at baseline will not be eligible for this trial.\n5. Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Have adequate organ function as indicated by the following laboratory values:\n\n   1. Adequate hematological function defined by absolute neutrophil count (ANC) ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, and hemoglobin\n\n      ≥8 g/dL (without transfusions within 1 week of first dose).\n   2. Adequate hepatic function based on a total bilirubin level <1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level ≤2.5 x IULN, alanine aminotransferase (ALT) level ≤2.5 x IULN, and alkaline phosphatase ≤2.5 IULN.\n   3. Adequate renal function defined as creatinine ≤1.5 x IULN OR calculated creatinine clearance ≥50 mL/min for subjects with creatinine levels >1.5 x IULN (if no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).\n   4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy)\n7. Other than the cancer for which the subject is enrolled, have no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous-cell carcinoma of the skin, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n\n   Note: In Phase 2, the history and time requirement for no evidence of disease for 5 years does not apply to the cancer for which the subject is enrolled in the trial.\n8. In Phase 2, subjects must provide a sufficient and adequate formalin fixed paraffin embedded (FFPE) tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease has been made AND from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required.\n\n   Note: Tissue from needle or excisional biopsy or from resection is required.\n9. Female subjects must have a negative serum pregnancy test at screening (within 72 hours of first dose of study drug) if of childbearing potential or be of non- childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):\n\n   1. ≥45 years of age and has not had menses for greater than 1 year,\n   2. Amenorrheic for ≥ 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation,\n   3. Whose status is post hysterectomy, oophorectomy, or tubal ligation.\n10. If of childbearing potential, female subjects must be willing to use 2 highly effective contraceptive measures (defined in the informed consent form [ICF]) throughout the study, starting with the screening visit through 120 days after the last dose of study drug.\n\n    Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.\n11. Male subjects with a female partner(s) of childbearing potential must agree to use 2 highly effective contraceptive measures (defined in the ICF) throughout the trial starting with the screening visit through 120 days after the last dose of study drug is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n\n    Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.\n12. Is willing and able to comply with the requirements of the protocol.\n\nExclusion Criteria\n\nThe subject must be excluded from participating in the trial if the subject:\n\n1. Is currently participating and receiving trial therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n2. Has an inadequate washout period prior to first dose of study drug defined as:\n\n   1. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,\n   2. Received radiation therapy within 3 weeks before first dose, or\n   3. Had major surgery within 4 weeks before first dose.\n3. Has received prior therapy with:\n\n   1. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies\n   2. For Phase 2: >1 systemic treatment regimen for the locally advanced recurrent, and/or metastatic cervical cancer for which the subject is considered for the study. Subjects who received a systemic regimen immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation will only be considered as having 1 prior systemic regimen for the purpose of this criterion.\n\n   Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for subjects with metastatic melanoma.\n4. Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE) Grade >1 severity.\n\n   Note: Sensory neuropathy or alopecia of Grade ≤2 is acceptable.\n5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).\n6. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Version 4.03 Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.\n7. Is receiving systemic corticosteroid therapy ≤7 days prior to first dose of study treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events (AE), and/or a premedication for intravenous (IV) contrast allergies/reactions is allowed). Subjects who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.\n8. Has a central nervous system (CNS) tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to consent.\n\n   Note: Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images performed ≥4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥7 days prior to first dose of study drug.\n9. Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immunosuppressive systemic treatment.\n\n   Note: Subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n10. Has had an allogeneic tissue/solid organ transplant.\n11. Has or had interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.\n12. Has an active infection requiring IV systemic therapy.\n13. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n14. Has known active Hepatitis B, Hepatitis C, or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.\n15. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n19. Is legally incapacitated or has limited legal capacity.\n20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of AGEN2034 and/or AGEN1884.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Voluntarily agree to participate by giving written informed consent. (Participation in pharmacogenomics testing is optional.)",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily agree to participate by giving written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participation in pharmacogenomics testing is optional.",
                    "criterion": "pharmacogenomics testing participation",
                    "requirements": [
                        {
                            "requirement_type": "optional",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Be ≥18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Be ≥18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosis:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Phase 1: Male or female having a histologically or cytologically confirmed diagnosis of a locally advanced, recurrent, and/or metastatic solid tumor for which no standard therapy is available or standard therapy has failed.",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced, recurrent, and/or metastatic solid tumor",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "locally advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy is available or standard therapy has failed",
                    "criterion": "standard therapy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "no standard therapy available",
                                "standard therapy has failed"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Phase 2:",
            "criterions": [
                {
                    "exact_snippets": "Phase 2",
                    "criterion": "clinical trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "I. Female having (1) a histologically or cytologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) locally advanced, recurrent, and/or metastatic disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix",
                    "criterion": "cervical cancer type",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "squamous cell carcinoma",
                                "adenosquamous carcinoma",
                                "adenocarcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced, recurrent, and/or metastatic disease at the time of enrollment",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologic confirmation of the original primary tumor is required via pathology report",
                    "criterion": "histologic confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "cervical tumors ... minimal deviation/adenoma malignum",
                    "criterion": "cervical tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "minimal deviation/adenoma malignum"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical tumors ... gastric type adenocarcinoma",
                    "criterion": "cervical tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "gastric type adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical tumors ... clear cell carcinoma",
                    "criterion": "cervical tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "clear cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical tumors ... mesonephric carcinoma",
                    "criterion": "cervical tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "mesonephric carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "II. Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for locally advanced, recurrent, and/or metastatic disease; Note: Subjects who only received platinum-based chemotherapy concurrently with primary radiation (e.g., weekly cisplatin) or adjuvant chemotherapy following completion of radiation therapy (e.g., paclitaxel and carboplatin for ≤4 cycles) and progressed within 6 months after treatment completion will be eligible as this systemic therapy will be considered first line.",
            "criterions": [
                {
                    "exact_snippets": "Has cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has relapsed after a platinum-based treatment (first line) regimen",
                    "criterion": "relapse after platinum-based treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "platinum-based"
                        },
                        {
                            "requirement_type": "treatment line",
                            "expected_value": "first line"
                        },
                        {
                            "requirement_type": "relapse",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for locally advanced, recurrent, and/or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who only received platinum-based chemotherapy concurrently with primary radiation (e.g., weekly cisplatin) or adjuvant chemotherapy following completion of radiation therapy (e.g., paclitaxel and carboplatin for ≤4 cycles) and progressed within 6 months after treatment completion will be eligible",
                    "criterion": "progression after specific chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "chemotherapy type",
                            "expected_value": [
                                "platinum-based with primary radiation",
                                "adjuvant chemotherapy with radiation"
                            ]
                        },
                        {
                            "requirement_type": "progression time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Measurable Disease:",
            "criterions": [
                {
                    "exact_snippets": "Measurable Disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Phase 1: Have objective evidence of disease; the presence of measurable disease is not required.",
            "criterions": [
                {
                    "exact_snippets": "objective evidence of disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "objective"
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of measurable disease is not required",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Phase 2: Have measurable disease on imaging based on RECIST version 1.1. Note: Subjects must have at least one \"target lesion\" to be used to assess response, as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease on imaging based on RECIST version 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one \"target lesion\" ... as defined by RECIST version 1.1",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumors within a previously irradiated field ... \"non-target\" lesions unless progression is documented",
                    "criterion": "tumors within a previously irradiated field",
                    "requirements": [
                        {
                            "requirement_type": "designation",
                            "expected_value": "non-target lesions"
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
                    "criterion": "biopsy to confirm persistence",
                    "requirements": [
                        {
                            "requirement_type": "time since radiation therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review prior to first dose. Subjects without centrally confirmed measurable disease at baseline will not be eligible for this trial.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review",
                    "criterion": "measurable disease by RECIST 1.1",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "independent central radiologic review"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects without centrally confirmed measurable disease at baseline will not be eligible",
                    "criterion": "centrally confirmed measurable disease at baseline",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Have adequate organ function as indicated by the following laboratory values:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Adequate hematological function defined by absolute neutrophil count (ANC) ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, and hemoglobin",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count (ANC) ≥1.5 x 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥100 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "≥8 g/dL (without transfusions within 1 week of first dose).",
            "criterions": [
                {
                    "exact_snippets": "≥8 g/dL (without transfusions within 1 week of first dose)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        },
                        {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Adequate hepatic function based on a total bilirubin level <1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level ≤2.5 x IULN, alanine aminotransferase (ALT) level ≤2.5 x IULN, and alkaline phosphatase ≤2.5 IULN.",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin level <1.5 x the institutional upper limit of normal (IULN)",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) level ≤2.5 x IULN",
                    "criterion": "aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) level ≤2.5 x IULN",
                    "criterion": "alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase ≤2.5 IULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Adequate renal function defined as creatinine ≤1.5 x IULN OR calculated creatinine clearance ≥50 mL/min for subjects with creatinine levels >1.5 x IULN (if no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function defined as creatinine ≤1.5 x IULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance ≥50 mL/min for subjects with creatinine levels >1.5 x IULN",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy)",
            "criterions": [
                {
                    "exact_snippets": "international normalized ratio (INR) ... ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy)",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy)",
                    "criterion": "prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (aPTT) ≤1.5 x IULN (unless the subject is receiving anticoagulant therapy)",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Other than the cancer for which the subject is enrolled, have no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous-cell carcinoma of the skin, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.",
            "criterions": [
                {
                    "exact_snippets": "no history of prior malignancy",
                    "criterion": "history of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of ... superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of ... squamous-cell carcinoma of the skin",
                    "criterion": "squamous-cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy",
                    "criterion": "disease recurrence after curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "evidence of recurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: In Phase 2, the history and time requirement for no evidence of disease for 5 years does not apply to the cancer for which the subject is enrolled in the trial.",
            "criterions": [
                {
                    "exact_snippets": "history and time requirement for no evidence of disease for 5 years",
                    "criterion": "no evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. In Phase 2, subjects must provide a sufficient and adequate formalin fixed paraffin embedded (FFPE) tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease has been made AND from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required.",
            "criterions": [
                {
                    "exact_snippets": "sufficient and adequate formalin fixed paraffin embedded (FFPE) tumor tissue sample",
                    "criterion": "FFPE tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preferably from the most recent biopsy of a tumor lesion",
                    "criterion": "tumor tissue sample recency",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "most recent biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease",
                    "criterion": "tumor tissue sample collection timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of or after diagnosis of locally advanced, recurrent, and/or metastatic disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "from a site not previously irradiated",
                    "criterion": "tumor tissue sample site",
                    "requirements": [
                        {
                            "requirement_type": "irradiation status",
                            "expected_value": "not previously irradiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "If no tumor tissue is available, a fresh biopsy will be required",
                    "criterion": "fresh biopsy requirement",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "requirement",
                            "expected_value": "fresh biopsy required"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Tissue from needle or excisional biopsy or from resection is required.",
            "criterions": [
                {
                    "exact_snippets": "Tissue from needle or excisional biopsy or from resection is required.",
                    "criterion": "tissue from biopsy or resection",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ≥45 years of age and has not had menses for greater than 1 year,",
            "criterions": [
                {
                    "exact_snippets": "≥45 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has not had menses for greater than 1 year",
                    "criterion": "menstrual history",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Amenorrheic for ≥ 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation,",
            "criterions": [
                {
                    "exact_snippets": "Amenorrheic for ≥ 2 years",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without a hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without a ... oophorectomy",
                    "criterion": "oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "follicle-stimulating hormone (FSH) value in the postmenopausal range",
                    "criterion": "FSH value",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Whose status is post hysterectomy, oophorectomy, or tubal ligation.",
            "criterions": [
                {
                    "exact_snippets": "post hysterectomy",
                    "criterion": "hysterectomy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "post ... oophorectomy",
                    "criterion": "oophorectomy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "post ... tubal ligation",
                    "criterion": "tubal ligation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. If of childbearing potential, female subjects must be willing to use 2 highly effective contraceptive measures (defined in the informed consent form [ICF]) throughout the study, starting with the screening visit through 120 days after the last dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "If of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects must be willing to use 2 highly effective contraceptive measures",
                    "criterion": "use of contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.",
            "criterions": [
                {
                    "exact_snippets": "Abstinence is acceptable ... established and preferred contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "abstinence"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Male subjects with a female partner(s) of childbearing potential must agree to use 2 highly effective contraceptive measures (defined in the ICF) throughout the trial starting with the screening visit through 120 days after the last dose of study drug is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.",
            "criterions": [
                {
                    "exact_snippets": "Male subjects with a female partner(s) of childbearing potential",
                    "criterion": "male subject with female partner of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "agreement to use contraceptive measures",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Males with pregnant partners",
                    "criterion": "male subject with pregnant partner",
                    "requirements": [
                        {
                            "requirement_type": "agreement to use condom",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.",
            "criterions": [
                {
                    "exact_snippets": "Abstinence is acceptable ... established and preferred contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "abstinence"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Is willing and able to comply with the requirements of the protocol.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to comply with the requirements of the protocol",
                    "criterion": "compliance with protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Is currently participating and receiving trial therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Is currently participating and receiving trial therapy",
                    "criterion": "current participation in trial therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a study of an investigational agent",
                    "criterion": "past participation in a study of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received study therapy",
                    "criterion": "receipt of study therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "used an investigational device within 4 weeks of the first dose of treatment",
                    "criterion": "use of investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has an inadequate washout period prior to first dose of study drug defined as:",
            "criterions": [
                {
                    "exact_snippets": "inadequate washout period",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "inadequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,",
            "criterions": [
                {
                    "exact_snippets": "Received systemic cytotoxic chemotherapy",
                    "criterion": "systemic cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... biological therapy",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Received radiation therapy within 3 weeks before first dose, or",
            "criterions": [
                {
                    "exact_snippets": "Received radiation therapy within 3 weeks before first dose",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Had major surgery within 4 weeks before first dose.",
            "criterions": [
                {
                    "exact_snippets": "Had major surgery within 4 weeks before first dose.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has received prior therapy with:",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies",
            "criterions": [
                {
                    "exact_snippets": "Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies",
                    "criterion": "antibody/drug targeting T-cell co-regulatory proteins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. For Phase 2: >1 systemic treatment regimen for the locally advanced recurrent, and/or metastatic cervical cancer for which the subject is considered for the study. Subjects who received a systemic regimen immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation will only be considered as having 1 prior systemic regimen for the purpose of this criterion.",
            "criterions": [
                {
                    "exact_snippets": "For Phase 2: >1 systemic treatment regimen for the locally advanced recurrent, and/or metastatic cervical cancer",
                    "criterion": "systemic treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced recurrent, and/or metastatic cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who received a systemic regimen immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation will only be considered as having 1 prior systemic regimen",
                    "criterion": "systemic regimen after progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for subjects with metastatic melanoma.",
            "criterions": [
                {
                    "exact_snippets": "prior treatment with a CTLA-4 antibody is permissible",
                    "criterion": "prior treatment with CTLA-4 antibody",
                    "requirements": [
                        {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects with metastatic melanoma",
                    "criterion": "metastatic melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Sensory neuropathy or alopecia of Grade ≤2 is acceptable.",
            "criterions": [
                {
                    "exact_snippets": "Sensory neuropathy ... Grade ≤2 is acceptable",
                    "criterion": "sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia of Grade ≤2 is acceptable",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).",
            "criterions": [
                {
                    "exact_snippets": "require any other form of systemic or localized antineoplastic therapy",
                    "criterion": "requirement for antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "maintenance therapy with another agent",
                    "criterion": "maintenance therapy with another agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical resection",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Version 4.03 Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.",
            "criterions": [
                {
                    "exact_snippets": "known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Version 4.03 Grade ≥3)",
                    "criterion": "hypersensitivity reactions to fully human monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NCI-CTCAE Version 4.03 Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any history of anaphylaxis",
                    "criterion": "history of anaphylaxis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Is receiving systemic corticosteroid therapy ≤7 days prior to first dose of study treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events (AE), and/or a premedication for intravenous (IV) contrast allergies/reactions is allowed). Subjects who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.",
            "criterions": [
                {
                    "exact_snippets": "receiving systemic corticosteroid therapy ≤7 days prior to first dose of study treatment",
                    "criterion": "systemic corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving any other form of systemic immunosuppressive medication",
                    "criterion": "systemic immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Has a central nervous system (CNS) tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to consent.",
            "criterions": [
                {
                    "exact_snippets": "Has a central nervous system (CNS) tumor",
                    "criterion": "central nervous system (CNS) tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastasis(es)",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images performed ≥4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥7 days prior to first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "history of brain metastases",
                    "criterion": "history of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of stable supra-tentorial lesions",
                    "criterion": "stable supra-tentorial lesions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2 sets of brain images performed ≥4 weeks apart",
                    "criterion": "brain imaging interval",
                    "requirements": [
                        {
                            "requirement_type": "interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neurologic symptoms ... must have resolved or be minimal",
                    "criterion": "neurologic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "resolved or minimal"
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids must be discontinued ≥7 days prior to first dose",
                    "criterion": "steroid discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immunosuppressive systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has active or history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has required systemic treatment within 2 years of the start of study treatment",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 years of the start of study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immunosuppressive systemic treatment.",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "thyroxine",
                                "insulin",
                                "physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.",
            "criterions": [
                {
                    "exact_snippets": "diabetes type 1",
                    "criterion": "diabetes type 1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vitiligo",
                    "criterion": "vitiligo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psoriasis",
                    "criterion": "psoriasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypo-, or hyperthyroid disease",
                    "criterion": "thyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "not requiring immunosuppressive treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Has had an allogeneic tissue/solid organ transplant.",
            "criterions": [
                {
                    "exact_snippets": "Has had an allogeneic tissue/solid organ transplant",
                    "criterion": "allogeneic tissue/solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Has or had interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Has or had interstitial lung disease (ILD)",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has had a history of pneumonitis that has required oral or IV corticosteroids",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oral corticosteroids",
                                "IV corticosteroids"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Has an active infection requiring IV systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring IV systemic therapy",
                    "criterion": "IV systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).",
            "criterions": [
                {
                    "exact_snippets": "known history of Human Immunodeficiency Virus (HIV)",
                    "criterion": "Human Immunodeficiency Virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Has known active Hepatitis B, Hepatitis C, or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.",
            "criterions": [
                {
                    "exact_snippets": "Has known active Hepatitis B",
                    "criterion": "active Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active Hepatitis B is defined as a known positive HBsAg result",
                    "criterion": "HBsAg result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has known active ... Hepatitis C",
                    "criterion": "active Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active Hepatitis C is defined by a known positive Hep C Ab result",
                    "criterion": "Hep C Ab result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active Hepatitis C is defined by ... known quantitative HCV RNA results greater than the lower limits of detection of the assay",
                    "criterion": "quantitative HCV RNA results",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower limits of detection of the assay"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has known active ... tuberculosis",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant (i.e., active) cardiovascular disease",
                    "criterion": "clinically significant cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebral vascular accident/stroke ... within 6 months of enrollment",
                    "criterion": "cerebral vascular accident/stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months of enrollment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (New York Heart Association class ≥II)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "New York Heart Association class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmia requiring medication",
                    "criterion": "serious uncontrolled cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "requiring medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.",
            "criterions": [
                {
                    "exact_snippets": "Has a history or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).",
            "criterions": [
                {
                    "exact_snippets": "a regular user (including \"recreational use\") of any illicit drugs",
                    "criterion": "illicit drug use",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "regular"
                        }
                    ]
                },
                {
                    "exact_snippets": "had a recent history (within the last year) of substance abuse (including alcohol)",
                    "criterion": "substance abuse history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Is legally incapacitated or has limited legal capacity.",
            "criterions": [
                {
                    "exact_snippets": "Is legally incapacitated",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "incapacitated"
                        }
                    ]
                },
                {
                    "exact_snippets": "has limited legal capacity",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "limited"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of AGEN2034 and/or AGEN1884.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "intention to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "To be eligible for participation in this trial the subject must:",
            "criterions": []
        },
        {
            "line": "9. Female subjects must have a negative serum pregnancy test at screening (within 72 hours of first dose of study drug) if of childbearing potential or be of non- childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):",
            "criterions": [
                {
                    "exact_snippets": "Female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test",
                    "criterion": "serum pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "at screening (within 72 hours of first dose of study drug)",
                    "criterion": "timing of serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at screening (within 72 hours of first dose of study drug)"
                        }
                    ]
                },
                {
                    "exact_snippets": "if of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "be of non-childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "The subject must be excluded from participating in the trial if the subject:",
            "criterions": []
        },
        {
            "line": "4. Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE) Grade >1 severity.",
            "criterions": [
                {
                    "exact_snippets": "persisting toxicity related to prior therapy ... NCI-CTCAE Grade >1 severity",
                    "criterion": "persisting toxicity related to prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI-CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}