{
"info": {
"nct_id": "NCT04280848",
"official_title": "Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma",
"inclusion_criteria": "* Male or female patients, age ≥ 18 and ≤ 75 years old\n* Written informed consent\n* Histologically confirmed glioblastoma\n* Patient with known MGMT status:\n\nCohort A (recruitment closed) : unmethylated MGMT status ; Cohort B (recruiting) : unmethylated or methylated MGMT status\n\n* Patients previously pre-treated with standard radiochemotherapy (without the additional cures of temozolomide.)\n* Karnofsky Performance status ≥ 70%\n* Life-expectancy > 3 months\n* Adequate hematological, hepatic, and renal function.\n* Females must be using highly effective contraceptive measures , and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential.\n\nFemales of childbearing potential should use reliable methods of contraception from the time of the screening until 5 weeks after discontinuing study treatment.\n\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 5 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 5 months after discontinuing study treatment.\n\n- Affiliation to French social security or receiving such a regime.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Presence of known extracranial metastatic or leptomeningeal disease Glioblastoma with mutated IDH1 (assessed by Immunohistochemistry)\n* Current or recent treatment with another investigational drug\n* Carmustine implant during surgery\n* History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease...)\n* Prohibited medications:\n\n 1. Chronic treatment with immunosuppressive drugs\n 2. Ongoing requirement for supraphysiologic steroid defined as >10 mg prednisone daily (or equivalent)\n 3. Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to enrollment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or pulmonary disease) are eligible for the study\n* Known positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs\n* Non-hematologic toxicities Grade >1 severity (or, at the investigator's discretion, Grade >2 if not considered a safety risk for the patient).\n* Patient with intra-alveolar hemorrhage, pulmonary fibrosis, or uncontrolled asthma, or chronic obstructive disease (COPD), defined as at least 1 hospitalization within 4 months prior to enrollment or as at least 3 exacerbations during the last year prior to enrollment Hospitalization for cardiovascular or pulmonary disease within 4 weeks prior to enrollment.\n* Patients with LEVF<40%\n* Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or patient in the exclusion period of a previous clinical trial.\n* Pregnancy or lactating patients.\n* Patients with any severe/uncontrolled inter current illness, significant co morbid or psychiatric conditions that in the opinion of the investigator would impair study participation or cooperation.\n* Patients under guardianship, curatorship or under the protection of justice.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Male or female patients, age ≥ 18 and ≤ 75 years old",
"criterions": [
{
"exact_snippets": "Male or female patients",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "age ≥ 18 and ≤ 75 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Written informed consent",
"criterions": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "form",
"expected_value": "written"
}
]
}
]
},
{
"line": "* Histologically confirmed glioblastoma",
"criterions": [
{
"exact_snippets": "Histologically confirmed glioblastoma",
"criterion": "glioblastoma",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* Patient with known MGMT status:",
"criterions": [
{
"exact_snippets": "known MGMT status",
"criterion": "MGMT status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Cohort A (recruitment closed) : unmethylated MGMT status ; Cohort B (recruiting) : unmethylated or methylated MGMT status",
"criterions": [
{
"exact_snippets": "Cohort A ... unmethylated MGMT status",
"criterion": "MGMT status",
"requirements": [
{
"requirement_type": "methylation",
"expected_value": "unmethylated"
}
]
},
{
"exact_snippets": "Cohort B ... unmethylated or methylated MGMT status",
"criterion": "MGMT status",
"requirements": [
{
"requirement_type": "methylation",
"expected_value": [
"unmethylated",
"methylated"
]
}
]
}
]
},
{
"line": "* Patients previously pre-treated with standard radiochemotherapy (without the additional cures of temozolomide.)",
"criterions": [
{
"exact_snippets": "Patients previously pre-treated with standard radiochemotherapy",
"criterion": "pre-treatment with standard radiochemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "without the additional cures of temozolomide",
"criterion": "additional cures of temozolomide",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Karnofsky Performance status ≥ 70%",
"criterions": [
{
"exact_snippets": "Karnofsky Performance status ≥ 70%",
"criterion": "Karnofsky Performance status",
"requirements": [
{
"requirement_type": "performance status",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Life-expectancy > 3 months",
"criterions": [
{
"exact_snippets": "Life-expectancy > 3 months",
"criterion": "life-expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Adequate hematological, hepatic, and renal function.",
"criterions": [
{
"exact_snippets": "Adequate hematological ... function.",
"criterion": "hematological function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... hepatic ... function.",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... renal function.",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Females must be using highly effective contraceptive measures , and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential.",
"criterions": [
{
"exact_snippets": "Females must be using highly effective contraceptive measures",
"criterion": "contraceptive measures",
"requirements": [
{
"requirement_type": "effectiveness",
"expected_value": "highly effective"
}
]
},
{
"exact_snippets": "have a negative pregnancy test prior to the start of dosing",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
},
{
"exact_snippets": "if of childbearing potential",
"criterion": "childbearing potential",
"requirements": [
{
"requirement_type": "status",
"expected_value": "of childbearing potential"
}
]
},
{
"exact_snippets": "must have evidence of non-childbearing potential",
"criterion": "childbearing potential",
"requirements": [
{
"requirement_type": "status",
"expected_value": "non-childbearing potential"
}
]
}
]
},
{
"line": "Females of childbearing potential should use reliable methods of contraception from the time of the screening until 5 weeks after discontinuing study treatment.",
"criterions": [
{
"exact_snippets": "Females of childbearing potential",
"criterion": "gender and reproductive status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "females of childbearing potential"
}
]
},
{
"exact_snippets": "should use reliable methods of contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
},
{
"exact_snippets": "from the time of the screening until 5 weeks after discontinuing study treatment",
"criterion": "contraception duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "from the time of the screening until 5 weeks after discontinuing study treatment"
}
]
}
]
},
{
"line": "Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 5 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 5 months after discontinuing study treatment.",
"criterions": [
{
"exact_snippets": "Male patients",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected gender",
"expected_value": "male"
}
]
},
{
"exact_snippets": "female partner of childbearing potential",
"criterion": "partner's childbearing potential",
"requirements": [
{
"requirement_type": "childbearing potential",
"expected_value": true
}
]
},
{
"exact_snippets": "should be willing to use barrier contraception during the study and for 5 months following discontinuation of study drug",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
},
{
"requirement_type": "duration",
"expected_value": "during the study and for 5 months following discontinuation of study drug"
}
]
},
{
"exact_snippets": "Patients should refrain from donating sperm from the start of dosing until 5 months after discontinuing study treatment",
"criterion": "sperm donation",
"requirements": [
{
"requirement_type": "refrain from donating",
"expected_value": true
},
{
"requirement_type": "duration",
"expected_value": "from the start of dosing until 5 months after discontinuing study treatment"
}
]
}
]
},
{
"line": "- Affiliation to French social security or receiving such a regime.",
"criterions": [
{
"exact_snippets": "Affiliation to French social security",
"criterion": "affiliation to French social security",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "receiving such a regime",
"criterion": "receiving French social security regime",
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Presence of known extracranial metastatic or leptomeningeal disease Glioblastoma with mutated IDH1 (assessed by Immunohistochemistry)",
"criterions": [
{
"exact_snippets": "Presence of known extracranial metastatic ... disease",
"criterion": "extracranial metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Presence of known ... leptomeningeal disease",
"criterion": "leptomeningeal disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Glioblastoma with mutated IDH1",
"criterion": "IDH1 mutation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Glioblastoma with mutated IDH1",
"criterion": "glioblastoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Current or recent treatment with another investigational drug",
"criterions": [
{
"exact_snippets": "Current or recent treatment with another investigational drug",
"criterion": "treatment with another investigational drug",
"requirements": [
{
"requirement_type": "recency",
"expected_value": "current or recent"
}
]
}
]
},
{
"line": "* Carmustine implant during surgery",
"criterions": [
{
"exact_snippets": "Carmustine implant during surgery",
"criterion": "Carmustine implant",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease...)",
"criterions": [
{
"exact_snippets": "History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease...)",
"criterion": "autoimmune diseases",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Prohibited medications:",
"criterions": [
{
"exact_snippets": "Prohibited medications",
"criterion": "medications",
"requirements": [
{
"requirement_type": "prohibition",
"expected_value": true
}
]
}
]
},
{
"line": "1. Chronic treatment with immunosuppressive drugs",
"criterions": [
{
"exact_snippets": "Chronic treatment with immunosuppressive drugs",
"criterion": "immunosuppressive drug treatment",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "chronic"
}
]
}
]
},
{
"line": "2. Ongoing requirement for supraphysiologic steroid defined as >10 mg prednisone daily (or equivalent)",
"criterions": [
{
"exact_snippets": "Ongoing requirement for supraphysiologic steroid defined as >10 mg prednisone daily (or equivalent)",
"criterion": "supraphysiologic steroid",
"requirements": [
{
"requirement_type": "ongoing requirement",
"expected_value": true
},
{
"requirement_type": "dosage",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "mg prednisone daily"
}
}
]
}
]
},
{
"line": "3. Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to enrollment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or pulmonary disease) are eligible for the study",
"criterions": [
{
"exact_snippets": "Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to enrollment.",
"criterion": "treatment with therapeutic antibiotics",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
},
{
"requirement_type": "route of administration",
"expected_value": [
"oral",
"IV"
]
}
]
},
{
"exact_snippets": "Patients receiving prophylactic antibiotics ... are eligible for the study",
"criterion": "prophylactic antibiotics",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "* Known positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs",
"criterions": [
{
"exact_snippets": "Known positive serology for Human Immunodeficiency Virus (HIV)",
"criterion": "HIV serology",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "Known positive serology for ... Hepatitis C virus (HCV)",
"criterion": "HCV serology",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "presence in the serum of the antigens HBs",
"criterion": "HBs antigen",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Non-hematologic toxicities Grade >1 severity (or, at the investigator's discretion, Grade >2 if not considered a safety risk for the patient).",
"criterions": [
{
"exact_snippets": "Non-hematologic toxicities Grade >1 severity",
"criterion": "non-hematologic toxicities",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "Grade"
}
}
]
},
{
"exact_snippets": "at the investigator's discretion, Grade >2 if not considered a safety risk for the patient",
"criterion": "non-hematologic toxicities",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "Grade"
}
},
{
"requirement_type": "safety risk",
"expected_value": false
}
]
}
]
},
{
"line": "* Patient with intra-alveolar hemorrhage, pulmonary fibrosis, or uncontrolled asthma, or chronic obstructive disease (COPD), defined as at least 1 hospitalization within 4 months prior to enrollment or as at least 3 exacerbations during the last year prior to enrollment Hospitalization for cardiovascular or pulmonary disease within 4 weeks prior to enrollment.",
"criterions": [
{
"exact_snippets": "intra-alveolar hemorrhage",
"criterion": "intra-alveolar hemorrhage",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "pulmonary fibrosis",
"criterion": "pulmonary fibrosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "uncontrolled asthma",
"criterion": "uncontrolled asthma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "chronic obstructive disease (COPD)",
"criterion": "chronic obstructive disease (COPD)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "at least 1 hospitalization within 4 months prior to enrollment",
"criterion": "hospitalization for COPD",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "hospitalizations"
}
},
{
"requirement_type": "time frame",
"expected_value": "4 months prior to enrollment"
}
]
},
{
"exact_snippets": "at least 3 exacerbations during the last year prior to enrollment",
"criterion": "exacerbations for COPD",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "exacerbations"
}
},
{
"requirement_type": "time frame",
"expected_value": "last year prior to enrollment"
}
]
},
{
"exact_snippets": "Hospitalization for cardiovascular or pulmonary disease within 4 weeks prior to enrollment",
"criterion": "hospitalization for cardiovascular or pulmonary disease",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "4 weeks prior to enrollment"
}
]
}
]
},
{
"line": "* Patients with LEVF<40%",
"criterions": [
{
"exact_snippets": "LEVF<40%",
"criterion": "LEVF",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or patient in the exclusion period of a previous clinical trial.",
"criterions": [
{
"exact_snippets": "Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment",
"criterion": "participation in a clinical study with an investigational product",
"requirements": [
{
"requirement_type": "time since participation",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "patient in the exclusion period of a previous clinical trial",
"criterion": "exclusion period of a previous clinical trial",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnancy or lactating patients.",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating patients",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients with any severe/uncontrolled inter current illness, significant co morbid or psychiatric conditions that in the opinion of the investigator would impair study participation or cooperation.",
"criterions": [
{
"exact_snippets": "any severe/uncontrolled inter current illness",
"criterion": "inter current illness",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe/uncontrolled"
}
]
},
{
"exact_snippets": "significant co morbid ... conditions",
"criterion": "co morbid conditions",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "significant"
}
]
},
{
"exact_snippets": "significant ... psychiatric conditions",
"criterion": "psychiatric conditions",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "significant"
}
]
}
]
},
{
"line": "* Patients under guardianship, curatorship or under the protection of justice.",
"criterions": [
{
"exact_snippets": "Patients under guardianship",
"criterion": "guardianship",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "curatorship",
"criterion": "curatorship",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "under the protection of justice",
"criterion": "protection of justice",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}