{
    "info": {
        "nct_id": "NCT04939701",
        "official_title": "A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1",
        "inclusion_criteria": "Phase 1 Dose Escalation only:\n\n- Participant has relapsed/refractory (R/R) solid tumor known to express NY-ESO-1 after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy. NY-ESO-1 expression status is not required for participant entry.\n\nSafety Lead-in, Phase 2 Single agent and Combination Therapy only:\n\n* Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease after undergoing available SOC treatment or is not a candidate for SOC therapy (must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen, if not a candidate for either agent).\n\n  * Participant has not received prior checkpoint inhibitor therapy (i.e., Programmed Cell Death Protein 1 [PD-1]/Programmed Death Ligand 1 [PD-L1] treatment naive)\n  * SS: confirmation by the presence of a translocation between SYT on the X chromosome and SSX1, SSX2, or SSX4 on chromosome 18 (may be presented in the pathology report as t [X;18]).\n  * MRCL: confirmation by the presence of the reciprocal chromosomal translocation t (12;16) (q13;p11) or t(12;22)(q13;q12).\n* Participant has R/R ovarian cancer that is:\n\n  * platinum resistant OR platinum-sensitive, but the participant is not a candidate for platinum or other SOC therapy.\n  * Participant has not received prior checkpoint inhibitor therapy (i.e., naive PD-1/PD-L1 treatment participants).\n* Participant has R/R solid tumor (melanoma, non-small cell lung cancer [NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell carcinoma [ESCC]) after available SOC treatment or is not a candidate for SOC therapy (single-agent only).\n* Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides prior to IP administration.\n* Participant in phase 2 consents to provide tumor specimen obtained within 56 days prior to first dose of study treatment, as tissue block or unstained serial slides.\n* Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.\n* Participant with life expectancy of >= 12 weeks at the time of screening.\n* Participant must meet criteria for clinical laboratory tests during screening period.\n* A female participant is eligible to participate if she is not pregnant and at least one of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final investigational product (IP) administration.\n* Female participant must not be breastfeeding at screening or during the study period and for 6 months after the final IP administration.\n* Female participant must not donate ova at screening and throughout the study period and for 6 months after the final IP administration.\n* A male participant with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 6 months after the final IP administration.\n* Male participant must not donate sperm starting at screening and throughout the study period and for 6 months after the final IP administration.\n* Participant agrees not to participate in another interventional study while on treatment.\n* Participant measurable disease according to RECIST 1.1. For participant with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0), with symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery).\n* Participant has received any of the following therapies (for inclusion in the study, all abnormalities must have returned to <= grade 1):\n\n  * Systemic immunomodulators (checkpoint inhibitors)-except the dose escalation phase and the NY-ESO-1 solid tumor (melanoma, NSCLC-adenocarcinoma and squamous cell and ESCC) cohorts in the dose expansion phase of monotherapy, which may have received prior checkpoint inhibitor therapy\n  * Immunosuppressive drugs including steroids <= 14 days prior to treatment\n  * Cytotoxic agents <= 14 days prior to treatment\n  * Investigational agent <= 21 days prior to treatment or 5 half-lives, whichever is shorter\n  * Radiation therapy <= 21 days prior to treatment\n* Participant has clinically active or untreated nervous system metastases. Participants with previously treated Central Nervous System (CNS) metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.\n* Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.\n* Participant was discontinued from prior immunomodulatory therapy due to a grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.\n* Participant has known history of serious hypersensitivity reaction to a known ingredient of ASP0739 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.\n* Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years prior to screening visit, except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.\n* Participant has received a prior allogeneic bone marrow or solid organ transplant.\n* Participant has an active uncontrolled infection within 14 days of treatment.\n* Participant is known to have human immunodeficiency virus infection.\n* Participant has active hepatitis B or C or other active hepatic disorder or participant is on hepatitis treatment. Hepatitis C RNA testing is not required in participants with negative hepatitis C antibody testing.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.\n* Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Participant is expected to require another form of anti-cancer therapy while on study treatment.\n* Participant has a known or suspected hypersensitivity to bovine-derived protein or has suspected hypersensitivity to any ingredients of ASP0739.\n\nAdditional Exclusion Criteria for Participants in Combination Therapy Cohorts\n\n* Participants with a history of myocarditis or congestive heart failure (as defined by New York Heart Associated Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry.\n* Participants with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.\n* Participants with baseline pulse oximetry < 92% \"on Room air.\"\n* Participants must not have known microsatellite instability-high or deficient MisMatch Repair.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Phase 1 Dose Escalation only:",
            "criterions": [
                {
                    "exact_snippets": "Phase 1 Dose Escalation",
                    "criterion": "trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "Phase 1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Dose Escalation",
                    "criterion": "dose escalation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Participant has relapsed/refractory (R/R) solid tumor known to express NY-ESO-1 after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy. NY-ESO-1 expression status is not required for participant entry.",
            "criterions": [
                {
                    "exact_snippets": "Participant has relapsed/refractory (R/R) solid tumor",
                    "criterion": "relapsed/refractory solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to express NY-ESO-1",
                    "criterion": "NY-ESO-1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy",
                    "criterion": "Standard of Care (SOC) therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion or candidacy",
                            "expected_value": [
                                "completed",
                                "not a candidate"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Safety Lead-in, Phase 2 Single agent and Combination Therapy only:",
            "criterions": [
                {
                    "exact_snippets": "Safety Lead-in",
                    "criterion": "safety lead-in",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "lead-in"
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase 2",
                    "criterion": "trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Single agent",
                    "criterion": "therapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "single agent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Combination Therapy",
                    "criterion": "therapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "combination therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease after undergoing available SOC treatment or is not a candidate for SOC therapy (must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen, if not a candidate for either agent).",
            "criterions": [
                {
                    "exact_snippets": "Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "relapsed/refractory synovial sarcoma",
                                "myxoid/round cell liposarcoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "after undergoing available SOC treatment or is not a candidate for SOC therapy",
                    "criterion": "SOC treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen",
                    "criterion": "previous treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "anthracycline containing regimen",
                                "ifosfamide containing regimen",
                                "another systemic regimen"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has not received prior checkpoint inhibitor therapy (i.e., Programmed Cell Death Protein 1 [PD-1]/Programmed Death Ligand 1 [PD-L1] treatment naive)",
            "criterions": [
                {
                    "exact_snippets": "Participant has not received prior checkpoint inhibitor therapy (i.e., Programmed Cell Death Protein 1 [PD-1]/Programmed Death Ligand 1 [PD-L1] treatment naive)",
                    "criterion": "prior checkpoint inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SS: confirmation by the presence of a translocation between SYT on the X chromosome and SSX1, SSX2, or SSX4 on chromosome 18 (may be presented in the pathology report as t [X;18]).",
            "criterions": [
                {
                    "exact_snippets": "presence of a translocation between SYT on the X chromosome and SSX1, SSX2, or SSX4 on chromosome 18",
                    "criterion": "translocation between SYT and SSX1, SSX2, or SSX4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* MRCL: confirmation by the presence of the reciprocal chromosomal translocation t (12;16) (q13;p11) or t(12;22)(q13;q12).",
            "criterions": [
                {
                    "exact_snippets": "presence of the reciprocal chromosomal translocation t (12;16) (q13;p11)",
                    "criterion": "reciprocal chromosomal translocation t (12;16) (q13;p11)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of the reciprocal chromosomal translocation ... t(12;22)(q13;q12)",
                    "criterion": "reciprocal chromosomal translocation t(12;22)(q13;q12)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has R/R ovarian cancer that is:",
            "criterions": [
                {
                    "exact_snippets": "R/R ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "R/R"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platinum resistant OR platinum-sensitive, but the participant is not a candidate for platinum or other SOC therapy.",
            "criterions": [
                {
                    "exact_snippets": "platinum resistant",
                    "criterion": "platinum resistance",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "resistant"
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum-sensitive",
                    "criterion": "platinum sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "participant is not a candidate for platinum or other SOC therapy",
                    "criterion": "candidate for platinum or other SOC therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has not received prior checkpoint inhibitor therapy (i.e., naive PD-1/PD-L1 treatment participants).",
            "criterions": [
                {
                    "exact_snippets": "Participant has not received prior checkpoint inhibitor therapy",
                    "criterion": "prior checkpoint inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "naive PD-1/PD-L1 treatment participants",
                    "criterion": "PD-1/PD-L1 treatment",
                    "requirements": [
                        {
                            "requirement_type": "experience",
                            "expected_value": "naive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has R/R solid tumor (melanoma, non-small cell lung cancer [NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell carcinoma [ESCC]) after available SOC treatment or is not a candidate for SOC therapy (single-agent only).",
            "criterions": [
                {
                    "exact_snippets": "Participant has R/R solid tumor (melanoma, non-small cell lung cancer [NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell carcinoma [ESCC])",
                    "criterion": "solid tumor type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "melanoma",
                                "non-small cell lung cancer [NSCLC]-adenocarcinoma",
                                "squamous cell",
                                "esophageal squamous cell carcinoma [ESCC]"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "after available SOC treatment",
                    "criterion": "SOC treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is not a candidate for SOC therapy (single-agent only)",
                    "criterion": "SOC therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides prior to IP administration.",
            "criterions": [
                {
                    "exact_snippets": "Participant consents to provide an archival tumor specimen",
                    "criterion": "archival tumor specimen",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in a tissue block or unstained serial slides",
                    "criterion": "format of tumor specimen",
                    "requirements": [
                        {
                            "requirement_type": "format",
                            "expected_value": [
                                "tissue block",
                                "unstained serial slides"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant in phase 2 consents to provide tumor specimen obtained within 56 days prior to first dose of study treatment, as tissue block or unstained serial slides.",
            "criterions": [
                {
                    "exact_snippets": "Participant in phase 2 consents to provide tumor specimen",
                    "criterion": "tumor specimen",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor specimen obtained within 56 days prior to first dose of study treatment",
                    "criterion": "tumor specimen",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 56,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor specimen ... as tissue block or unstained serial slides",
                    "criterion": "tumor specimen",
                    "requirements": [
                        {
                            "requirement_type": "format",
                            "expected_value": [
                                "tissue block",
                                "unstained serial slides"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period.",
            "criterions": [
                {
                    "exact_snippets": "Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or excision)",
                    "criterion": "tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "core needle biopsy",
                                "excision"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of <= 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant with life expectancy of >= 12 weeks at the time of screening.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of >= 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must meet criteria for clinical laboratory tests during screening period.",
            "criterions": [
                {
                    "exact_snippets": "criteria for clinical laboratory tests",
                    "criterion": "clinical laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "meet"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A female participant is eligible to participate if she is not pregnant and at least one of the following conditions apply:",
            "criterions": [
                {
                    "exact_snippets": "female participant",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not a woman of childbearing potential (WOCBP) OR",
            "criterions": [
                {
                    "exact_snippets": "Not a woman of childbearing potential (WOCBP)",
                    "criterion": "woman of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final investigational product (IP) administration.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to follow the contraceptive guidance",
                    "criterion": "contraceptive guidance adherence",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "throughout the treatment period and for at least 6 months after the final investigational product (IP) administration",
                    "criterion": "contraceptive guidance duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the treatment period and for at least 6 months after the final investigational product (IP) administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participant must not be breastfeeding at screening or during the study period and for 6 months after the final IP administration.",
            "criterions": [
                {
                    "exact_snippets": "Female participant must not be breastfeeding at screening or during the study period and for 6 months after the final IP administration.",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participant must not donate ova at screening and throughout the study period and for 6 months after the final IP administration.",
            "criterions": [
                {
                    "exact_snippets": "Female participant must not donate ova",
                    "criterion": "ova donation",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "screening and throughout the study period and for 6 months after the final IP administration",
                    "criterion": "time period for ova donation prohibition",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "screening and throughout the study period and for 6 months after the final IP administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A male participant with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 6 months after the final IP administration.",
            "criterions": [
                {
                    "exact_snippets": "male participant",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "female partner(s) of childbearing potential",
                    "criterion": "partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "childbearing potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the treatment period and for at least 6 months after the final IP administration",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the treatment period and for at least 6 months after the final IP administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male participant must not donate sperm starting at screening and throughout the study period and for 6 months after the final IP administration.",
            "criterions": [
                {
                    "exact_snippets": "Male participant must not donate sperm",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting at screening and throughout the study period and for 6 months after the final IP administration",
                    "criterion": "sperm donation prohibition duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "starting at screening and throughout the study period and for 6 months after the final IP administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant agrees not to participate in another interventional study while on treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participant agrees not to participate in another interventional study",
                    "criterion": "participation in another interventional study",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant measurable disease according to RECIST 1.1. For participant with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Participant measurable disease according to RECIST 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "participant with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy",
                    "criterion": "measurable lesion location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "outside the field of prior radiotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "participant with only 1 measurable lesion and prior radiotherapy ... must have documented progression following radiation therapy",
                    "criterion": "lesion progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "documented progression following radiation therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participant has persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0), with symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery).",
            "criterions": [
                {
                    "exact_snippets": "persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0)",
                    "criterion": "non-hematological toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery)",
                    "criterion": "treatment type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "chemotherapy",
                                "kinase inhibitors",
                                "immunotherapy",
                                "experimental agents",
                                "radiation",
                                "surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has received any of the following therapies (for inclusion in the study, all abnormalities must have returned to <= grade 1):",
            "criterions": [
                {
                    "exact_snippets": "Participant has received any of the following therapies",
                    "criterion": "therapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "all abnormalities must have returned to <= grade 1",
                    "criterion": "abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic immunomodulators (checkpoint inhibitors)-except the dose escalation phase and the NY-ESO-1 solid tumor (melanoma, NSCLC-adenocarcinoma and squamous cell and ESCC) cohorts in the dose expansion phase of monotherapy, which may have received prior checkpoint inhibitor therapy",
            "criterions": [
                {
                    "exact_snippets": "Systemic immunomodulators (checkpoint inhibitors)",
                    "criterion": "systemic immunomodulators",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "NY-ESO-1 solid tumor (melanoma, NSCLC-adenocarcinoma and squamous cell and ESCC)",
                    "criterion": "NY-ESO-1 solid tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "melanoma",
                                "NSCLC-adenocarcinoma",
                                "squamous cell",
                                "ESCC"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "dose escalation phase",
                    "criterion": "trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "dose escalation"
                        }
                    ]
                },
                {
                    "exact_snippets": "dose expansion phase of monotherapy",
                    "criterion": "trial phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "dose expansion"
                        }
                    ]
                },
                {
                    "exact_snippets": "may have received prior checkpoint inhibitor therapy",
                    "criterion": "prior checkpoint inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunosuppressive drugs including steroids <= 14 days prior to treatment",
            "criterions": [
                {
                    "exact_snippets": "Immunosuppressive drugs including steroids <= 14 days prior to treatment",
                    "criterion": "immunosuppressive drug use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cytotoxic agents <= 14 days prior to treatment",
            "criterions": [
                {
                    "exact_snippets": "Cytotoxic agents <= 14 days prior to treatment",
                    "criterion": "cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Investigational agent <= 21 days prior to treatment or 5 half-lives, whichever is shorter",
            "criterions": [
                {
                    "exact_snippets": "Investigational agent <= 21 days prior to treatment or 5 half-lives, whichever is shorter",
                    "criterion": "investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy <= 21 days prior to treatment",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy <= 21 days prior to treatment",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has clinically active or untreated nervous system metastases. Participants with previously treated Central Nervous System (CNS) metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "clinically active or untreated nervous system metastases",
                    "criterion": "nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "clinically active",
                                "untreated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated Central Nervous System (CNS) metastases ... clinically stable",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "previously treated"
                        },
                        {
                            "requirement_type": "clinical stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment",
                    "criterion": "CNS progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence by imaging",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks",
                    "criterion": "systemic steroid use",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "mg per day of hydrocortisone"
                            }
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg per day of prednisone or equivalent"
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Participant has an active autoimmune disease.",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "type 1 diabetes mellitus",
                    "criterion": "type 1 diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "endocrinopathies stably maintained on appropriate replacement therapy",
                    "criterion": "endocrinopathies",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stably maintained on appropriate replacement therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment",
                    "criterion": "skin disorders",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "not requiring systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant was discontinued from prior immunomodulatory therapy due to a grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.",
            "criterions": [
                {
                    "exact_snippets": "Participant was discontinued from prior immunomodulatory therapy",
                    "criterion": "discontinuation from prior immunomodulatory therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "due to a grade >= 3 toxicity",
                    "criterion": "toxicity grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "mechanistically related (e.g., immune related) to the agent",
                    "criterion": "mechanistic relation to the agent",
                    "requirements": [
                        {
                            "requirement_type": "relation",
                            "expected_value": "mechanistically related"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has known history of serious hypersensitivity reaction to a known ingredient of ASP0739 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.",
            "criterions": [
                {
                    "exact_snippets": "known history of serious hypersensitivity reaction to a known ingredient of ASP0739",
                    "criterion": "hypersensitivity reaction to ASP0739 ingredient",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of serious hypersensitivity reaction to ... pembrolizumab",
                    "criterion": "hypersensitivity reaction to pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hypersensitivity reaction to treatment with another monoclonal antibody",
                    "criterion": "hypersensitivity reaction to monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years prior to screening visit, except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.",
            "criterions": [
                {
                    "exact_snippets": "prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years prior to screening visit",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast",
                    "criterion": "locally curable malignancies",
                    "requirements": [
                        {
                            "requirement_type": "cure status",
                            "expected_value": "apparently cured"
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "basal or squamous cell skin cancer",
                                "superficial bladder cancer",
                                "carcinoma in situ of the cervix",
                                "carcinoma in situ of the breast"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has received a prior allogeneic bone marrow or solid organ transplant.",
            "criterions": [
                {
                    "exact_snippets": "Participant has received a prior allogeneic bone marrow or solid organ transplant.",
                    "criterion": "prior allogeneic transplant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has an active uncontrolled infection within 14 days of treatment.",
            "criterions": [
                {
                    "exact_snippets": "active uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days of treatment",
                    "criterion": "time since infection",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is known to have human immunodeficiency virus infection.",
            "criterions": [
                {
                    "exact_snippets": "Participant is known to have human immunodeficiency virus infection.",
                    "criterion": "human immunodeficiency virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has any condition which makes the participant unsuitable for study participation.",
            "criterions": [
                {
                    "exact_snippets": "any condition which makes the participant unsuitable for study participation",
                    "criterion": "suitability for study participation",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "any condition which makes the participant unsuitable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participant has had a major surgical procedure",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has not completely recovered within 28 days prior to the start of study treatment",
                    "criterion": "recovery from major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since recovery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction ... within 6 months prior to the start of study treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina ... within 6 months prior to the start of study treatment",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled illness ... symptomatic congestive heart failure",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "symptomatic congestive heart failure"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled illness ... clinically significant cardiac disease",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "clinically significant cardiac disease"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled illness ... unstable angina pectoris",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "unstable angina pectoris"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled illness ... cardiac arrhythmia",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "cardiac arrhythmia"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "psychiatric illness/social situations that would limit compliance with study requirements"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is expected to require another form of anti-cancer therapy while on study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participant is expected to require another form of anti-cancer therapy",
                    "criterion": "requirement for another form of anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a known or suspected hypersensitivity to bovine-derived protein or has suspected hypersensitivity to any ingredients of ASP0739.",
            "criterions": [
                {
                    "exact_snippets": "known or suspected hypersensitivity to bovine-derived protein",
                    "criterion": "hypersensitivity to bovine-derived protein",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "suspected hypersensitivity to any ingredients of ASP0739",
                    "criterion": "hypersensitivity to ingredients of ASP0739",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with a history of myocarditis or congestive heart failure (as defined by New York Heart Associated Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "history of myocarditis",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (as defined by New York Heart Associated Functional Classification III or IV)",
                    "criterion": "congestive heart failure classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction 6 months prior to study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.",
            "criterions": [
                {
                    "exact_snippets": "active interstitial lung disease (ILD)/pneumonitis",
                    "criterion": "active interstitial lung disease (ILD)/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ILD/pneumonitis requiring treatment with systemic steroids",
                    "criterion": "history of ILD/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systemic steroids"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with baseline pulse oximetry < 92% \"on Room air.\"",
            "criterions": [
                {
                    "exact_snippets": "baseline pulse oximetry < 92%",
                    "criterion": "baseline pulse oximetry",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must not have known microsatellite instability-high or deficient MisMatch Repair.",
            "criterions": [
                {
                    "exact_snippets": "known microsatellite instability-high",
                    "criterion": "microsatellite instability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not high"
                        }
                    ]
                },
                {
                    "exact_snippets": "deficient MisMatch Repair",
                    "criterion": "MisMatch Repair",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not deficient"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Participant has active hepatitis B or C or other active hepatic disorder or participant is on hepatitis treatment. Hepatitis C RNA testing is not required in participants with negative hepatitis C antibody testing.",
            "criterions": [
                {
                    "exact_snippets": "Participant has active hepatitis B",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "active hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other active hepatic disorder",
                    "criterion": "other active hepatic disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "participant is on hepatitis treatment",
                    "criterion": "hepatitis treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Additional Exclusion Criteria for Participants in Combination Therapy Cohorts",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}