{
    "info": {
        "nct_id": "NCT03997448",
        "official_title": "Phase II Study of the Combination of Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149",
        "inclusion_criteria": "* Patients with histologically confirmed metastatic or locally advanced unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Be willing and able to provide written informed consent for the trial.\n* Age >= 18 years at the time of consent.\n* Prior treatment with at least two lines of systemic therapy for advanced disease. Patients who have received neoadjuvant or adjuvant therapy or definitive chemoradiation and had recurrence during or within 6 months of completion of all treatments may count adjuvant therapy as one chemotherapy line.\n* Presence of measurable disease based on RECIST 1.1 as determined by local site investigator/radiology assessment.\n* ECOG PS 0-1.\n* Patients must have discontinued all previous treatments for cancer (including cytotoxic chemotherapy, molecularly targeted therapy, radiotherapy, and investigational therapy).\n* Patients who received chemotherapy must have recovered (CTCAE Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy. A washout period of at least 21 days is required between last systemic therapy dose and treatment initiation per protocol.\n* A washout period of at least 14 days is required between end of radiotherapy and treatment initiation.\n* The patient is able to swallow oral medications.\n* Demonstrate adequate organ function as defined in the table in the protocol.\n* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.\n* Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 60 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.\n* Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 60 days after the last dose of study drug. Total abstinence for the same time period is an acceptable alternative.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n* Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of prior therapy with CDK4 or CDK6 inhibitors or prior immune checkpoint inhibitors.\n* Patients with known microsatellite instability will be excluded.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the study PI.\n* Serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Symptomatic central nervous system metastasis. Screening of asymptomatic patients is not required for enrollment.\n* Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include curatively treated basal cell and squamous cell carcinoma of the skin, curatively resected in situ cervical and/or breast cancers, in situ or intramucosal pharyngeal cancer, and Gleason 6 prostate cancer with PSA <10.\n* Patients who have received a live vaccine within 30 days of planned start of pembrolizumab.\n\nNote: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines, and are not allowed.\n\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Active infection requiring systemic therapy.\n* Patients who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 60 days after the last dose of pembrolizumab or abemaciclib. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with histologically confirmed metastatic or locally advanced unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or locally advanced unresectable",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locally advanced unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric, gastroesophageal junction or esophageal adenocarcinoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "gastric adenocarcinoma",
                                "gastroesophageal junction adenocarcinoma",
                                "esophageal adenocarcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be willing and able to provide written informed consent for the trial.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >= 18 years at the time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Age >= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with at least two lines of systemic therapy for advanced disease. Patients who have received neoadjuvant or adjuvant therapy or definitive chemoradiation and had recurrence during or within 6 months of completion of all treatments may count adjuvant therapy as one chemotherapy line.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with at least two lines of systemic therapy for advanced disease.",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "lines of systemic therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have received neoadjuvant or adjuvant therapy or definitive chemoradiation and had recurrence during or within 6 months of completion of all treatments may count adjuvant therapy as one chemotherapy line.",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during or within 6 months of completion of all treatments"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of measurable disease based on RECIST 1.1 as determined by local site investigator/radiology assessment.",
            "criterions": [
                {
                    "exact_snippets": "Presence of measurable disease based on RECIST 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "assessment method",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG PS 0-1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have discontinued all previous treatments for cancer (including cytotoxic chemotherapy, molecularly targeted therapy, radiotherapy, and investigational therapy).",
            "criterions": [
                {
                    "exact_snippets": "discontinued all previous treatments for cancer",
                    "criterion": "previous cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cytotoxic chemotherapy",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "molecularly targeted therapy",
                    "criterion": "molecularly targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "investigational therapy",
                    "criterion": "investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who received chemotherapy must have recovered (CTCAE Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy. A washout period of at least 21 days is required between last systemic therapy dose and treatment initiation per protocol.",
            "criterions": [
                {
                    "exact_snippets": "received chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered (CTCAE Grade ≤1) from the acute effects of chemotherapy",
                    "criterion": "recovery from acute effects of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for residual alopecia",
                    "criterion": "residual alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... Grade 2 peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "washout period of at least 21 days is required between last systemic therapy dose and treatment initiation",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A washout period of at least 14 days is required between end of radiotherapy and treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "washout period of at least 14 days ... between end of radiotherapy and treatment initiation",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is able to swallow oral medications.",
            "criterions": [
                {
                    "exact_snippets": "able to swallow oral medications",
                    "criterion": "ability to swallow oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Demonstrate adequate organ function as defined in the table in the protocol.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in the table in the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential must have a negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to registration",
                    "criterion": "timing of serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "procedures",
                            "expected_value": [
                                "hysterectomy",
                                "bilateral tubal ligation",
                                "bilateral oophorectomy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "they are naturally postmenopausal for at least 12 consecutive months",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 60 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to abstain from heterosexual activity",
                    "criterion": "abstinence from heterosexual activity",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use 2 forms of effective methods of contraception",
                    "criterion": "contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "methods"
                            }
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    ]
                },
                {
                    "exact_snippets": "The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.",
                    "criterion": "types of contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "composition",
                            "expected_value": [
                                "two barrier methods",
                                "a barrier method plus a hormonal method"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "from the time of informed consent until 60 days after treatment discontinuation",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from the time of informed consent until 60 days after treatment discontinuation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 60 days after the last dose of study drug. Total abstinence for the same time period is an acceptable alternative.",
            "criterions": [
                {
                    "exact_snippets": "Men who are not surgically sterile (vasectomy)",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use an acceptable method of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study",
                    "criterion": "female partner pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "pregnant",
                                "possibly pregnant",
                                "could become pregnant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use condoms from the first dose of study drug through at least 60 days after the last dose of study drug",
                    "criterion": "condom use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Total abstinence for the same time period is an acceptable alternative",
                    "criterion": "total abstinence",
                    "requirements": [
                        {
                            "requirement_type": "alternative",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.",
            "criterions": [
                {
                    "exact_snippets": "ability of the subject to understand and comply with study procedures",
                    "criterion": "ability to understand and comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.",
            "criterions": [
                {
                    "exact_snippets": "Provided written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIPAA authorization for release of personal health information",
                    "criterion": "HIPAA authorization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease that has required systemic treatment in past 2 years",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "not considered systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prior therapy with CDK4 or CDK6 inhibitors or prior immune checkpoint inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "History of prior therapy with CDK4 or CDK6 inhibitors",
                    "criterion": "prior therapy with CDK4 or CDK6 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of prior ... prior immune checkpoint inhibitors",
                    "criterion": "prior therapy with immune checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known microsatellite instability will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "known microsatellite instability",
                    "criterion": "microsatellite instability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the study PI.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to the first dose of trial treatment",
                    "criterion": "timing of therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).",
            "criterions": [
                {
                    "exact_snippets": "interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe dyspnea at rest or requiring oxygen therapy",
                    "criterion": "severe dyspnea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "at rest or requiring oxygen therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of major surgical resection involving the stomach or small bowel",
                    "criterion": "major surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "involving the stomach or small bowel"
                        }
                    ]
                },
                {
                    "exact_snippets": "preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea",
                    "criterion": "chronic condition resulting in diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic central nervous system metastasis. Screening of asymptomatic patients is not required for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.",
            "criterions": [
                {
                    "exact_snippets": "Personal history of ... syncope of cardiovascular etiology",
                    "criterion": "syncope",
                    "requirements": [
                        {
                            "requirement_type": "etiology",
                            "expected_value": "cardiovascular"
                        }
                    ]
                },
                {
                    "exact_snippets": "Personal history of ... ventricular arrhythmia of pathological origin",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": "pathological"
                        }
                    ]
                },
                {
                    "exact_snippets": "Personal history of ... sudden cardiac arrest",
                    "criterion": "sudden cardiac arrest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include curatively treated basal cell and squamous cell carcinoma of the skin, curatively resected in situ cervical and/or breast cancers, in situ or intramucosal pharyngeal cancer, and Gleason 6 prostate cancer with PSA <10.",
            "criterions": [
                {
                    "exact_snippets": "Known additional malignancy that progressed or required active treatment within the last 2 years.",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "active treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated basal cell and squamous cell carcinoma of the skin",
                    "criterion": "basal cell and squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment outcome",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively resected in situ cervical and/or breast cancers",
                    "criterion": "in situ cervical and/or breast cancers",
                    "requirements": [
                        {
                            "requirement_type": "treatment outcome",
                            "expected_value": "curatively resected"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ or intramucosal pharyngeal cancer",
                    "criterion": "in situ or intramucosal pharyngeal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason 6 prostate cancer with PSA <10",
                    "criterion": "Gleason 6 prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "PSA level",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": ""
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received a live vaccine within 30 days of planned start of pembrolizumab.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received a live vaccine within 30 days of planned start of pembrolizumab.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines, and are not allowed.",
            "criterions": [
                {
                    "exact_snippets": "killed virus vaccines used for seasonal influenza vaccines for injection are allowed",
                    "criterion": "killed virus vaccines for seasonal influenza",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines, and are not allowed",
                    "criterion": "intranasal influenza vaccines",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "History of (non-infectious) pneumonitis that required steroids",
                    "criterion": "history of non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis",
                    "criterion": "current pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy.",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 60 days after the last dose of pembrolizumab or abemaciclib. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)",
            "criterions": [
                {
                    "exact_snippets": "Patients who are 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": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}