A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female subjects age 18 years or older with diagnosis of advanced (stage IB1-IVA) 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. Patients who are recommended to receive anto-PD-1 or anti-PD-L1 therapy after chemoradiation are eligible to enroll and can continue to receive such therapy while receiving study drug. * No history of or current evidence of residual disease or disease recurrence based on…
Interventions
- DrugPVX7
PVX7 Immunotherapy
Locations (2)
- The University of Alabama at BirminghamBirmingham, Alabama
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland