PVX7 Immunotherapy for Advanced Cervical Cancer
This study is testing a new immunotherapy called PVX7 in women with advanced cervical cancer. You may be able to join if you are 18 or older, have HPV-positive cervical cancer (meaning the human papillomavirus caused your cancer), and have finished your main treatments like surgery, radiation, or chemotherapy within the last year. Researchers want to see how safe PVX7 is and if it's practical to give. They will look for any side effects over 12 months. This study is currently recruiting 32 participants, but the overall status is unclear.
- Study design
- This is a feasibility study where 32 patients are randomly assigned to one of two groups (1:1 ratio) to receive PVX7 through either intramuscular (into the muscle) or skin injections.
- What's involved
- You would receive PVX7 vaccinations at weeks 1, 5, and 9. You must be HIV-negative to participate.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 2 years after treatment according to standard medical care.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06315257
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Recruiting
PHASE1Ages 18+InterventionalTreatmentSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~32 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:PVX7
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of PVX7 as assessed by adverse events
Measured over 12 months
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesAlabama1
Maryland1
Study leadership
- Stephanie Gaillard, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
creatinine \< 1.5 X ULN or estimated creatinine clearance ≥ 60 ml/min per Modified Cockcroft-Gault Formula
Eastern Cooperative Oncology Group performance status of 0 or 1
All clinically significant toxicities related to prior therapy should be less than or equal to Grade 1 at time of enrollment
Ability and willingness for one month post vaccination to follow vaccine inoculation site care and avoid close social contact with children under 1 year old or close social or domestic contact with a pregnant woman or individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, or immunodeficiency states including HIV infection
Exclusion
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).
History or presence of atopic dermatitis
Inability or unwillingness to for one month post vaccination follow vaccine inoculation site care and avoid social contact with children under 1 year old or close social or domestic contact with a pregnant woman or individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, or immunodeficiency states including HIV infection
What this trial measures
- Safety of PVX7 as assessed by adverse events12 months
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 PVX712 months
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.