A Pilot Clinical Trial Assessing the Safety and Feasibility of Intramuscular Administration of the TA-CIN Vaccine as Adjuvant Therapy for Patients with History of HPV16 Associated Cervical Cancer
Amanda Nickles Fader
Johns Hopkins Kimmel Cancer Center in Baltimore
This is a randomized, multi-center, open label pilot study. The primary goal of this study is to determine the safety of TA-CIN vaccine as adjuvant therapy, and to assess evidence of induction of HPV antigen-specific immunologic response when administered at different locations (arm or thigh). In this pilot study, a single dose level (100µg) assessment of the safety and tolerability of administering TA-CIN vaccine three times to either the arm versus the thigh of patients who have previously been treated for HPV16-related cervical cancer in the past year and are documented to have no evidence of disease recurrence based on standard-of-care imaging and/or clinical assessment upon eligibility.
Inclusion Criteria:1. Females 18 years old or older2. Patients with HPV16 related stage IB1-IV cervical cancer who completed definitive treatment within 12 months3. Patients with no evidence of disease recurrence within 8 weeks of enrollment4. Documented to have HPV16 postive cervical tumor specimen5. Tissue must be available for testing for HPV16 for central confirmation6. ECOG Performance Status of 0 to 17. Adequate organ function as defined by study-specified laboratory tests8. Willing and able to sign informed consent form9. Willing and able to comply with study proceduresExclusion Criteria:1. Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications (Ex. systemic steroids)2. Prior HPV vaccination (prophylactic or therapeutic)3. Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug4. Patients who have had surgery within 28 days of dosing of the study drug, excluding minor procedures (dental work, skin biopsy, etc)5. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements6. Patients who have an active autoimmune disease7. Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids8. Patients with a recognized immunodeficiency disease9. Women of child-bearing potential10. Patient with active or chronic infection of HIV, HCV, or HBV11. Patients with non-healed wounds12. A history of current or recent concurrent malignancy ( equal to 5 years) except basal cell cancer.13. Inability to understand or unwillingness to sign an informed consent document
A total of 14 patients will be enrolled to assess the safety of TA-CIN vaccine via different injection sites as adjuvant therapy. Safety assessments will continue for a period for 1 month after the last vaccination. Few or no serious adverse events (SAEs) are expected from this regimen and routes of administration. The motivation for the design is to confirm that the dose and site of injection implemented here has minimal or no systemic toxicity, as well as determining the preferred injection site that can elicit more potent immune response.The study will consist of the following parts:Screening evaluationDosing period and response assessmentsFollow-up visits after last doseScreening Evaluation The screening visit will be performed within 21 days of the first study drug administration visit. The study team will check the results of these screening tests to see if patient qualifies to participate.Dosing Period Those who meet the study requirements during the screening period will then begin the dosing phase of this study. TA-CIN will be given as a single intramuscular injection every 4 weeks for a maximum of 3 times. The location of the injection (arm or thigh) will depend on randomization. Patients will be assessed for safety and response to treatment during this period.Follow-Up Period Four follow-up evaluations will be performed during a clinic visit after the last dose of the vaccine. These will take place at the following time points: (1) 1-3 weeks after the last dose of the study drug, (2) about 6 months after the last dose of the study drug, (3) about 12 months after the last dose of the study drug, and (4) about 24 months after the last dose of the study drug.
01/19/2020 05:03 AM