A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
Female subjects age 18 years or older with diagnosis of advanced (stage IB1-IVA) HPV+ cervical cancer and have completed primary treatment (consisting of any of the following as per NCCN guideline standard of care: surgical resection, radiation, and/or platinum-based chemotherapy) within the past 12 months.
No history of or current evidence of residual disease or disease recurrence based on imaging and clinical assessments within 8 weeks of enrollment
HIV uninfected
Hepatitis B surface antigen negative
Women of child-bearing potential (i.e., those who have had fertility-sparing procedures for the management of cervical cancer) will be excluded unless agreed to remain sexually abstinent or have a partner who is sterile (i.e. vasectomy), or use methods of contraception (e.g., oral contraception, barrier methods, spermicide, intrauterine device (IUD)), throughout the first 6 months of the study.
Because there is a risk for adverse events in nursing infants, breastfeeding must be discontinued if the mother is treated on study.
Diagnosed with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients diagnosed with acquired, hereditary, or congenital immunodeficiencies
Diagnosis with a medical condition that requires systemic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), alkylating agents, antimetabolites, radiation, Tumor Necrosis Factor (TNF) inhibitors, or systemic corticosteroids, either chronically or within 30 days of first PVX7 vaccination.
Parallel
PVX7
DrugPVX7 Immunotherapy
Safety of PVX7 as assessed by adverse events
To assess the safety of PVX7 immunotherapy to patients with advanced cervical cancer who have completed primary therapy by evaluating Adverse Events (AEs).
Feasibility of PVX7
To assess the feasibility of PVX7 immunotherapy to patients with advanced cervical cancer who have completed primary therapy. Feasibility is measured by the ability of patients to receive all three doses of vaccine.
Cellular Immune Response
To evaluate the systemic Human Papillomavirus (HPV)16/18 E6/E7-specific cellular immune responses to PVX7 immunotherapy by measuring the number of interferon gamma+ Cluster of Differentiation (CD)8 Tcells/mL with overlapping peptides covering HPV16/18 E6/E7 protein
Immune Response
To compare the route of administration associated with the greatest immune response in patients with advanced cervical cancer who have completed primary standard of care treatment
Presence of circulating HPV DNA
Measure presence of circulating HPV DNA load in blood pre- and post-PVX7 immunotherapy
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
