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NCT06686043 · ClinicalTrials.gov registry record · Phase 2
HPV Vaccine, Imiquimod, and Metformin Combination Trial
A Phase 2 study of Cervical Carcinoma and Vulvar Carcinoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 2
- Study locations
NCT06686043: Recruiting Phase 2 study of Cervical Carcinoma and Vulvar Carcinoma, sponsored by Baylor College of Medicine.
NCT06686043 is a Phase 2 study of Cervical Carcinoma and Vulvar Carcinoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 85 participants, below the 532-participant average among 25 other Cervical Carcinoma trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06686043, a Phase 2 study of Cervical Carcinoma and Vulvar Carcinoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Progression-free survival at 24 months will be collected for all patients.
Conditions Studied
Interventions
- DRUG HPV vaccine, Imiquimod, and metformin combination therapy
Study Locations (2)
Texas
- Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer Center - Houston
- Harris Health Smith Clinic - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2028-08-23 |
| Phase | Phase 2 |
What NCT06686043 shows while recruiting
NCT06686043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 532-participant average among 25 other Cervical Carcinoma trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Cervical Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which HPV vaccine, Imiquimod, and metformin combination therapy is the first listed.
NCT06686043 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06686043 about?
NCT06686043 is a clinical study titled "HPV Vaccine, Imiquimod, and Metformin Combination Trial". 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. ...
What is the current status of trial NCT06686043?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2024-08-23. Estimated completion is 2028-08-23.
What conditions does trial NCT06686043 study?
This clinical trial studies the following conditions: Cervical Carcinoma, Vulvar Carcinoma, Vaginal Carcinoma, HPV (Human Papillomavirus)-Associated Carcinoma.
What interventions are being tested in trial NCT06686043?
The interventions under investigation include: HPV vaccine, Imiquimod, and metformin combination therapy (DRUG).
Who is sponsoring clinical trial NCT06686043?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06686043 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06686043's enrollment target sits among peer trials
85 16th of 25 higher than 10 of 25 other Cervical Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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