NCT06315257

A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients

A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.

Detailed 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 IM injection * Schedule for administration: PVX7 vaccination at weeks 1, 5, and 9 * Follow-up for 2 years per standard of care (SoC)

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	PVX7	PVX7 Immunotherapy

Timeline

• Start date: 2025-09-22
• Primary completion: 2028-04-01
• Completion: 2029-10-01
• First posted: 2024-03-18
• Last updated: 2025-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study