PVX7 for Cervical Cancer

Recruiting at 1 trial location

Overseen By Amy Deery, RN

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Autoimmune diseases, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, PVX7, for individuals with advanced cervical cancer who have completed their main treatment. The researchers aim to determine if this vaccine is safe and can potentially benefit those with no remaining signs of cancer. Two methods are being tested: injection into the muscle and application to the skin. Candidates for this trial include those who have had advanced cervical cancer, completed main treatments within the past year, and show no signs of the disease based on recent check-ups. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the PVX7 trial?

The trial does not specify if you need to stop taking your current medications, but you can continue anti-PD-1 or anti-PD-L1 therapy if you are already on it. If you are on immunosuppressive drugs or need ongoing anticoagulation, you may need to stop those before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the pBI-11 DNA vaccine, when combined with TA-HPV, strengthens the immune system against cancers linked to HPV. Previous studies have examined how well these vaccines work together to protect against HPV types 16 and 18, which are often found in cervical cancer.

Detailed safety information for this trial's treatments is not yet available, but insights can be gained from the trial phase. Phase 1 trials are early tests that assess the safety and tolerability of the treatment in people. This provides some understanding of the treatment's safety, though it remains in the early stages of testing.

In other studies, these vaccines have shown promise, but ongoing and future research will provide more information about their safety. Participation in these trials helps gather this important information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PVX7 for cervical cancer because it introduces a novel approach using a combination of pBI-11 DNA and TA-HPV. Unlike standard treatments like surgery, radiation, or chemotherapy, PVX7 aims to stimulate the immune system to target cancer cells directly. This immunotherapy is delivered either through intramuscular injection or skin scarification, offering flexible delivery methods that could enhance patient comfort and treatment efficacy. This innovative mechanism could represent a significant step forward in personalized cancer care.

What evidence suggests that this trial's treatments could be effective for cervical cancer?

Research has shown that the pBI-11 DNA vaccine, when combined with the TA-HPV vaccine, strengthens the body's defense against cancers caused by HPV. This trial will evaluate two methods of administering this combination: IM Injection and Skin Scarification. The combination boosts the activity of CD8+ T cells, which play a crucial role in attacking cancer cells. Studies have also found that this vaccine approach can significantly slow tumor growth. When used with other treatments, these vaccines have demonstrated even better tumor control. These findings suggest that the pBI-11 DNA and TA-HPV vaccines could effectively treat advanced cervical cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephanie Gaillard, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for advanced cervical cancer patients who've finished their main treatment. They must not have HIV or hepatitis, be willing to follow the study rules, and sign a consent form. Their blood counts need to meet specific levels and they shouldn't have any signs of cancer coming back when checked by doctors.

Inclusion Criteria

My white blood cell count is healthy.

I do not have hepatitis B.

I do not have hepatitis C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PVX7 immunotherapy with vaccinations at weeks 1, 5, and 9

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• PVX7

Trial Overview The PVX7 vaccine is being tested in this trial as an immunotherapy regimen for those with advanced cervical cancer. The goal is to see if it's feasible to use this vaccine after primary therapy has been completed.

How Is the Trial Designed?

Group I: pBI-11 DNA plus TA-HPV via Skin Scarification Experimental Treatment 1 Intervention

Participants will receive pBI-11 DNA and TA-HPV via Skin Scarification

Group II: pBI-11 DNA plus TA-HPV via IM Injection Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7845631/

Development of DNA Vaccine Targeting E6 and E7 Proteins of ... The pBI-11 DNA vaccine may be used with TA-HPV in a heterologous prime-boost strategy to enhance HPV 16/18 E6/E7-specific CD8 + T cell responses.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10607554/

A Therapeutic DNA Vaccine Targeting HPV16 E7 in ... Our results showed that the Ad-E7 vaccine effectively inhibited tumor growth and increased the proportion of interferon-gamma (IFN-γ)-secreting ...

3. cellandbioscience.biomedcentral.com cellandbioscience.biomedcentral.com/articles/10.1186/s13578-024-01338-x

Improved efficacy of therapeutic HPV DNA vaccine using ... Taken together, our data suggests that pBI-11 DNA vaccination via IM with EP generated the strongest preventative antitumor effect among all ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05799144

NCT05799144 | pBI-11 & TA-HPV (With Pembrolizumab as ... This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating ...

5. journals.asm.org journals.asm.org/doi/abs/10.1128/mbio.03224-20

Development of DNA Vaccine Targeting E6 and E7 Proteins of ... Combination of the pBI-11 DNA and TA-HPV boost vaccination with PD-1 antibody blockade significantly improved the control of TC-1 tumors and extended the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8874761/

Therapeutic DNA Vaccines against HPV-Related ... Globally, these HPV-associated malignancies account for 4.5% of all human cancers, with an estimated annual case burden between 500,000 and 600,000 since 2012 [ ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06315257

Study Details | NCT06315257 | A Clinical Trial to Assess ... Study Overview. Brief Summary. A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.

8. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/hpv-16-18-e6-e7-dna-vaccine-pbi-11?pn=1

Clinical Trials Using HPV 16/18 E6/E7 DNA Vaccine pBI-11 Review the clinical trials studying hpv 16/18 e6/e7 dna vaccine pbi-11 on this list and use the filters to refine the results by age and location.