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HPV Vaccine + Imiquimod + Metformin for Cervical Cancer (HPV-VIM Trial)

Phase 2

Recruiting

Led By Jan S Sunde, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Must not have

Patients who have untreated, new or progressive brain metastases or leptomeningeal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if additional treatments can boost the immune system to fight cancer caused by the Human Papillomavirus (HPV). The trial will test if combining experimental therapies with standard treatment helps

Who is the study for?

This trial is for individuals with cancers caused by HPV, such as cervical, vulvar, and vaginal cancer. Participants will use the treatments alongside their standard therapy. They must be able to attend regular visits for vaccinations, sample collections, cream application, and follow a regimen of daily pills and thrice-weekly suppositories.

What is being tested?

The study tests if combining an HPV vaccine with imiquimod (a cream that stimulates immune response) and metformin (a diabetes drug thought to fight cancer) improves the body's ability to combat HPV-related cancers when used with standard treatments.

What are the potential side effects?

Potential side effects may include skin irritation from imiquimod cream or suppository use; reactions at the vaccination site; blood sugar changes due to metformin; plus any additional effects from enhancing the immune system's activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis B virus load is undetectable with treatment.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I am 18 years old or older.

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I am HIV positive with a CD4 count over 200 and follow my HIV treatment plan. I've had a CT or PET-CT scan in the last 56 days.

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I can take care of myself but might not be able to do heavy physical work.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have new or worsening brain metastases that haven't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival

Secondary study objectives

Common Toxicity Criteria (CTC)

Identify Immune changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment groupExperimental Treatment1 Intervention

The treatment group will be compared to a historical control. The investigator will evaluate the immune changes within the tumor microenvironment and validate why the combination immunotherapy study elicited such a robust immune response which led to complete resolution of the cancer, in comparison to the standard of care, chemoradiation. In this study, participants will undergo a series of treatment visits during and after radiation therapy to assess the effectiveness of the experimental combination therapy.

0 / 7Eligibility criteria met