Cervical Cancer Clinical Trial
Official title:
A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
A Feasibility Trial of PVX7 in advanced cervical cancer patients who have completed primary definitive therapy. - Safety and immunogenicity study - Patients are randomized in a 1:1 ratio to two cohorts, up to 16 patients in each of intramuscular or skin scarification vaccine injection, up to 32 patients total - Human Immunodeficiency Virus (HIV)-negative patients only - Treatment dose: Arm A: pBI-11 DNA (3 mg) twice via intramuscular (IM) injection, followed by one dose of TA-HPV (2.5x105 pfu) via skin scarification; Arm B: pBI-11 DNA (3 mg) twice, followed by one dose of TA-HPV (107 pfu) via IM injection - Schedule for administration: PVX7 vaccination at weeks 1, 5, and 9 - Follow-up for 2 years per standard of care (SoC) ;
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