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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02821494
Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented evidence of HPV16 positive (pre)malignant lesion following standard treatment
2. Patient with a tumor should have no evidence of residual disease based on physical examination at the completion of curative intent therapy
3. At least four weeks and less than twelve weeks after last anti-tumor treatment
4. Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines
5. Patients must be 18 years or older.
6. Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study (up to 2 months after the last vaccination)
7. Patients must be in good general health and ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
1. Radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to the enrolment visit
2. History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy, except for topical application
3. History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the current tumor or premalignant lesion
4. Receipt of another investigational product within the previous 4 weeks or at any time during the study period.
5. Receipt of prior HPV directed immunotherapy
6. Hematology and biochemistry:
* Absolute Neutrophil Count (ANC) \< 1.5 x 109/L, or platelet count \< 100 x 109/L or hemoglobin \< 6 mmol/L.
* Serum (total) bilirubin \> 2 x upper normal limit (ULN);
* Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) \> 2.5 x ULN;
* Alkaline phosphatase levels \> 2.5 x ULN;
* Serum creatinine \> ULN or calculated clearance \</= 40 mL/min/1.73 m2 for patients with serum creatinine levels above the institutional normal value
7. Human immunodeficiency virus (HIV), chronic hepatitis B or C infection.
8. Any condition that in the opinion of the investigator could interfere with the conduct of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02821494
Study Brief:
Protocol Section:
NCT02821494