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

NCT06315257 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: J23105sIRBIRB00388854
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  12 months

• 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.

  12 months

Secondary Outcomes (3)

• Cellular Immune Response

  12 months

• Immune Response

  12 months

• Presence of circulating HPV DNA

  12 months

Study Arms (2)

pBI-11 DNA plus TA-HPV via Skin Inoculation

EXPERIMENTAL

Participants will receive pBI-11 DNA by IM injection and TA-HPV via Skin Inoculation

Drug: PVX7

pBI-11 DNA plus TA-HPV via IM Injection

EXPERIMENTAL

Participants will receive pBI-11 DNA and TA-HPV via IM Injection

Drug: PVX7

Interventions

PVX7 DRUG

PVX7 Immunotherapy

Also known as: pBI-11 DNA + TA-HPV

pBI-11 DNA plus TA-HPV via IM Injection; pBI-11 DNA plus TA-HPV via Skin Inoculation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals with a cervix
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 imaging and clinical assessments within 8 weeks of enrollment
• HIV uninfected
• Hepatitis B surface antigen negative
• Anti-hepatitis C (HCV) antibody negative or negative HCV polymerase chain reaction (PCR)
• Patients who are able and willing to comply with all study procedures and voluntarily sign an informed consent form
• Adequate organ function as defined by the following parameters:
• white blood cell count ≥ 3,000 cells/cu mm
• lymphocyte number ≥ 500 cells/cu mm
• absolute neutrophil count ≥ 1,000 cells/cu mm
• platelets ≥ 90,000/cu mm
• hemoglobin ≥ 9 g/dL
• total bilirubin \<1.5 X upper limit of normal (ULN), \<3 x ULN if Gilbert's disease
• Aspartate Transferase(AST) and Alanine Transaminase (ALT) \<3 X ULN

You may not qualify if:

• 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.
• Administration of any blood product within 30 days of signing informed consent.
• Need for ongoing therapeutic anticoagulation during the study period due to concern for increased risk of bleeding.
• Previous severe allergic reaction or hypersensitivity to a vaccine or any of its components
• Participation in a study with an investigational compound or device within 30 days of signing informed consent
• Known active central nervous system disease
• Surgery within 30 days of first PVX7 vaccination, excluding minor procedures
• Diagnosis with an uncontrolled intercurrent illness including, but not limited to, ongoing, or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
• Diagnosis with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis)
• History of myocarditis or pericarditis.
• Known underlying heart disease (e.g., cardiomyopathy, congestive heart failure, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction or cerebrovascular accident within the past 6 months).
• Patients and the patients close social, sexual, or domestic contacts may not have non-healed wounds or active exfoliative skin conditions such as: Eczema, Burns, Impetigo, Varicella-zoster virus infection, Herpes simplex virus infection, Severe acne, Severe diaper dermatitis with extensive areas of denuded skin, Psoriasis, Lichen planus, Darier disease (keratosis follicularis).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

human papillomavirus vaccine, TA

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Stephanie Gaillard, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Gaillard, MD

CONTACT

410-614-1361; HopkinsGynTrials@jhmi.edu

Amy Deery, RN

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): April 1, 2032
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)