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Trial Title:
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
NCT ID:
NCT06315257
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PVX7
Description:
PVX7 Immunotherapy
Arm group label:
pBI-11 DNA plus TA-HPV via IM Injection
Arm group label:
pBI-11 DNA plus TA-HPV via Skin Scarification
Other name:
pBI-11 DNA + TA-HPV
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)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female subjects age 18 years or older with diagnosis of advanced cervical cancer and
have completed primary treatment 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
- lymphocyte number ≥ 500
- absolute neutrophil count ≥ 1,000
- platelets ≥ 90,000
- hemoglobin ≥ 9
- total bilirubin <1.5 X upper limit of normal (ULN), <3 x ULN if Gilbert's disease
- Aspartate Transferase(AST)/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 Criteria:
- 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
- History of seizures (unless seizure free for 5 years)
- 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
Gender:
Female
Gender based:
Yes
Gender description:
Individuals with a cervix
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2025
Completion date:
March 2027
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06315257