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HPV Vaccine, Imiquimod, and Metformin Combination Trial

NCT06686043 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-11-13

No results posted yet for this study

Summary

The goal of this clinical trial is to explore whether additional treatments can help strengthen the participant's immune system to fight cancer caused by the Human Papillomavirus (HPV), a virus spread through intimate skin-to-skin contact. The trial will also monitor the safety of these treatments. The main questions it aims to answer are:

Does the combination of treatments help the participant's body fight the cancer more effectively when used alongside standard therapy? What side effects or medical issues arise when using these experimental treatments? Researchers will use three experimental therapies along with the participant's standard treatment to find out if these therapies work better together than standard treatment alone.

Participants will:

Receive HPV vaccinations during the 2nd and 4th week of radiation, and again at weeks 8, 10, 12, and 16 after completing radiation.

Have blood samples taken, tumor cells brushed from the surface, and imiquimod cream applied during each visit.

Take a daily metformin pill and apply an imiquimod suppository three times a week for two weeks after each visit.

Conditions

  • Cervical Carcinoma
  • Vaginal Carcinoma
  • Vulvar Carcinoma
  • HPV (Human Papillomavirus)-Associated Carcinoma

Interventions

DRUG

HPV vaccine, Imiquimod, and metformin combination therapy

Participants in the treatment arm will have visits during the 2nd and 4th weeks of radiation, and then at weeks 8, 10, 12, and 16 after radiation. At each visit, a blood sample will be taken, and tumor cells collected using a cytobrush (or directly from the tumor for vulvar cancer). An HPV vaccine will be injected into the tumor, imiquimod cream will be applied topically, and participants will receive a subcutaneous vaccine shot. They will also take metformin tablets twice daily for two weeks and apply imiquimod cream at home three nights per week. Follow-up PET/CT scans will occur at week 20 and two years post-treatment, with exams every three months for two years.

Sponsors & Collaborators

  • Harris Health

    collaborator UNKNOWN

  • Dan L Duncan Comprehensive Cancer Center

    collaborator UNKNOWN

  • Baylor St. Luke's Medical Center

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Jan S Sunde, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2026-08-23
Completion
2028-08-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06686043 on ClinicalTrials.gov