Actively Recruiting
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-10-15
32
Participants Needed
2
Research Sites
210 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
CONDITIONS
Official Title
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects age 18 years or older with advanced cervical cancer (stage IB1-IVA) who have completed primary treatment within the past 12 months
- No evidence of residual disease or recurrence based on imaging and clinical assessments within 8 weeks of enrollment
- HIV negative
- Hepatitis B surface antigen negative
- Negative for hepatitis C antibody or hepatitis C PCR
- Able and willing to comply with all study procedures and sign informed consent
- Adequate organ function as defined by specific blood counts and liver and kidney function tests
- Eastern Cooperative Oncology Group performance status of 0 or 1
- All significant toxicities from prior therapy must be Grade 1 or less at enrollment
- Willing and able to follow vaccine site care and avoid close contact with certain vulnerable individuals for one month post vaccination
You will not qualify if you...
- Women of child-bearing potential not agreeing to remain sexually abstinent or use contraception for the first 6 months
- Breastfeeding mothers unless willing to stop while on study
- Diagnosed with recognized immunodeficiency diseases or acquired/hereditary/congenital immunodeficiencies
- Require systemic immunosuppressive treatment chronically or within 30 days before first vaccination
- Received any blood product within 30 days before consent
- Need ongoing therapeutic anticoagulation during the study
- History of severe allergic reaction to vaccines or components
- Participation in another investigational study within 30 days before consent
- History of seizures unless seizure-free for 5 years
- Known active central nervous system disease
- Major surgery within 30 days before first vaccination
- Uncontrolled illness or psychiatric/social conditions limiting compliance
- Active autoimmune diseases
- History of myocarditis or pericarditis
- Known underlying heart disease or recent major cardiac events
- Non-healed wounds or active exfoliative skin conditions in participant or close contacts
- History or presence of atopic dermatitis
- Unwillingness or inability to follow post-vaccination care and social contact restrictions
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
S
Stephanie Gaillard, MD
CONTACT
A
Amy Deery, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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