{
    "info": {
        "nct_id": "NCT02325557",
        "official_title": "A Phase 1-2 Dose-Escalation and Safety Study of ADXS31-142 Alone and of ADXS31-142 in Combination With Pembrolizumab (MK-3475) in Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer",
        "inclusion_criteria": "1. Have progressive mCRPC, on androgen deprivation therapy, based on at least one of the following criteria:\n\n   1. Prostate-specific antigen (PSA) progression, defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval with a minimum PSA of 2 ng/mL.\n   2. Progression of bi-dimensionally measurable soft tissue (nodal metastasis) assessed within 1 month prior to registration by computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis.\n   3. Progression of bone disease (evaluable disease) (new bone lesion[s]) by bone scan.\n2. Has discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks and enzalutamide >4 weeks prior to Day 1 of trial treatment\n3. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Received more than 3 prior systemic treatment regimens with chemotherapy, hormonal, or immunotherapy in the metastatic setting or received more than 1 prior chemotherapeutic regimen in the metastatic setting\n2. Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Day 1 of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.\n3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade ≤1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., Grade ≤1 or at baseline) from adverse events due to a previously administered agent.\n5. Has received prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed death-ligand-1 (PD-L1), or anti-Programmed death-ligand-2 (PD-L2) agent or if the participant has previously participated in a Merck MK-3475 clinical trial.\n6. Has a contraindication to administration of ampicillin or trimethoprim/ sulfamethoxazole.\n7. Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Have progressive mCRPC, on androgen deprivation therapy, based on at least one of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "progressive mCRPC",
                    "criterion": "progressive mCRPC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "on"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Prostate-specific antigen (PSA) progression, defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval with a minimum PSA of 2 ng/mL.",
            "criterions": [
                {
                    "exact_snippets": "Prostate-specific antigen (PSA) progression",
                    "criterion": "PSA progression",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval with a minimum PSA of 2 ng/mL"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Progression of bi-dimensionally measurable soft tissue (nodal metastasis) assessed within 1 month prior to registration by computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis.",
            "criterions": [
                {
                    "exact_snippets": "Progression of bi-dimensionally measurable soft tissue (nodal metastasis)",
                    "criterion": "bi-dimensionally measurable soft tissue (nodal metastasis)",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "assessed within 1 month prior to registration",
                    "criterion": "assessment timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis",
                    "criterion": "imaging method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "computed tomography (CT) scan",
                                "magnetic resonance imaging (MRI)"
                            ]
                        },
                        {
                            "requirement_type": "body region",
                            "expected_value": [
                                "abdomen",
                                "pelvis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Progression of bone disease (evaluable disease) (new bone lesion[s]) by bone scan.",
            "criterions": [
                {
                    "exact_snippets": "Progression of bone disease (evaluable disease) (new bone lesion[s]) by bone scan.",
                    "criterion": "bone disease progression",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "bone scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks and enzalutamide >4 weeks prior to Day 1 of trial treatment",
            "criterions": [
                {
                    "exact_snippets": "discontinued antiandrogens (bicalutamide, nilutamide) >6 weeks",
                    "criterion": "discontinuation of antiandrogens",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "specific drugs",
                            "expected_value": [
                                "bicalutamide",
                                "nilutamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinued ... enzalutamide >4 weeks",
                    "criterion": "discontinuation of enzalutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.",
            "criterions": [
                {
                    "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Received more than 3 prior systemic treatment regimens with chemotherapy, hormonal, or immunotherapy in the metastatic setting or received more than 1 prior chemotherapeutic regimen in the metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "Received more than 3 prior systemic treatment regimens with chemotherapy, hormonal, or immunotherapy in the metastatic setting",
                    "criterion": "prior systemic treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "regimens"
                            }
                        },
                        {
                            "requirement_type": "treatment types",
                            "expected_value": [
                                "chemotherapy",
                                "hormonal",
                                "immunotherapy"
                            ]
                        },
                        {
                            "requirement_type": "setting",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "received more than 1 prior chemotherapeutic regimen in the metastatic setting",
                    "criterion": "prior chemotherapeutic regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimens"
                            }
                        },
                        {
                            "requirement_type": "setting",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Day 1 of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving any systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving ... any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to Day 1 of trial treatment",
                    "criterion": "timeframe for therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to Day 1 of trial treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade ≤1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.",
            "criterions": [
                {
                    "exact_snippets": "Has had a prior monoclonal antibody within 4 weeks prior to study Day 1",
                    "criterion": "prior monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who has not recovered (i.e., Grade ≤1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., Grade ≤1 or at baseline) from adverse events due to a previously administered agent.",
            "criterions": [
                {
                    "exact_snippets": "Has had prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted small molecule therapy",
                    "criterion": "prior targeted small molecule therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy within 2 weeks prior to study Day 1",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has not recovered ... from adverse events due to a previously administered agent",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Grade ≤1"
                        },
                        {
                            "requirement_type": "comparison to baseline",
                            "expected_value": "at baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has received prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed death-ligand-1 (PD-L1), or anti-Programmed death-ligand-2 (PD-L2) agent or if the participant has previously participated in a Merck MK-3475 clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy with an anti-programmed cell death protein-1 (PD-1)",
                    "criterion": "prior therapy with anti-PD-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-programmed death-ligand-1 (PD-L1)",
                    "criterion": "prior therapy with anti-PD-L1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti-Programmed death-ligand-2 (PD-L2)",
                    "criterion": "prior therapy with anti-PD-L2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if the participant has previously participated in a Merck MK-3475 clinical trial",
                    "criterion": "participation in Merck MK-3475 clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has a contraindication to administration of ampicillin or trimethoprim/ sulfamethoxazole.",
            "criterions": [
                {
                    "exact_snippets": "contraindication to administration of ampicillin",
                    "criterion": "contraindication to ampicillin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindication to administration of ... trimethoprim/ sulfamethoxazole",
                    "criterion": "contraindication to trimethoprim/sulfamethoxazole",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.",
            "criterions": [
                {
                    "exact_snippets": "Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed",
                    "criterion": "implanted medical device",
                    "requirements": [
                        {
                            "requirement_type": "risk for colonization",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "removability",
                            "expected_value": "cannot be easily removed"
                        }
                    ]
                },
                {
                    "exact_snippets": "prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)",
                    "criterion": "specific implanted medical devices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "prosthetic joints",
                                "artificial heart valves",
                                "pacemakers",
                                "orthopedic screw(s)",
                                "metal plate(s)",
                                "bone graft(s)",
                                "other exogenous implant(s)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted",
                    "criterion": "common devices and prosthetics",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": [
                                "arterial and venous stents",
                                "dental implants",
                                "breast implants",
                                "venous access devices",
                                "Port-a-Cath",
                                "Mediport"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}