Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT02865135
Eligibility Criteria:
Inclusion Criteria:
* Each patient must be positive for HLA-A\*02 and meet all of the following inclusion criteria to be enrolled in the study:
* Histologically or cytologically proven HPVOC or cervical cancer or anal cancer, based on expression of HPV type16 in immunohistochemistry and/or HPV 16 DNA analysis by ISH of tumor tissue from the primary or metastatic lesions.
* Incurable HPVOC, as defined by:
* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. Surgery, radiotherapy or chemoradiotherapy) with no potentially curative option (i.e. surgery or radiation); OR
* Distant metastasis
* Incurable cervical or anal cancer, as defined by:
* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy). Chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; OR
* Distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs such as bevacizumab).
* Accessible tumors for sequential biopsies Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03) to grade 1 or better (except for \< grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis);
* Age ≥ 18 years;
* Measurable disease, according to modified RECIST 1.1 and irRECIST (Appendix B \& C);
* Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 (Appendix A)
* Adequate bone marrow, liver and renal function, defined by:
* Hemoglobin ≥ 10 g/dL;
* Absolute neutrophil count (ANC) ≥ 1000/μL;
* Absolute lymphocyte count ≥ 400/μL;
* Platelet count ≥ 100,000/μL;
* ALT and AST ≤ 2.5 X upper limit of normal (ULN);
* Total bilirubin ≤ 1.5 X ULN; and
* Serum creatinine ≤ 1.5 X ULN;
* Women of child-bearing potential (WOCBP) must be willing to use acceptable means of birth control;
* Men who could potentially father a child must also use birth control
* Signed informed consent
Exclusion Criteria:
* Radiotherapy for primary HPVOC within 8 weeks, or radiotherapy for any other reason within 3 weeks prior to the first dose of trial treatment;
* Chemotherapy within 3 weeks prior to the first dose of trial treatment;Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer;
* Inaccessible tumor or lack of consent for sequential biopsies
* Uncontrolled central nervous system (CNS) metastases (i.e. known CNS lesions that are radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids);
* Active hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids;
* Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy;
* Active uncontrolled serious infection;
* WOCBP who have a positive β-hCG test or are breastfeeding.
* Acute or chronic skin disorders that would interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions;
* Allergies to any vaccine, that after discussion with Immunovaccine, are serious enough to warrant exclusion from this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02865135
Study Brief:
Protocol Section:
NCT02865135