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NCT06686043: HPV-VIM

HPV Vaccine, Imiquimod, and Metformin Combination Trial

Recruiting now Phase 2 Last updated 13 November 2024
What this trial tests

Phase 2 trial testing HPV vaccine, Imiquimod, and metformin combination therapy in Cervical Carcinoma in 85 participants. Currently enrolling.

Timeline
23 August 2024
Primary endpoint
23 August 2026
23 August 2028

Quick facts

Lead sponsorBaylor College of Medicine
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment85
Start date23 August 2024
Primary completion23 August 2026
Estimated completion23 August 2028
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 64, female only, with Cervical Carcinoma or Vaginal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Senescent immune cells in the tumor microenvironment: emerging insights into cancer immunotherapy resistance.
    Gao D, Kan P, He Y, Sun S, et al · · 2025 · cited 5× · PMID 41181123 · DOI 10.3389/fimmu.2025.1656733
  2. Cervical cancer immune microenvironment: Mechanisms of HPV-mediated immune evasion and advances in immunotherapy (Review).
    Zhou X, An R, Li X. · · 2026 · PMID 41246557 · DOI 10.3892/ol.2025.15375

Verify or expand the search:

Other recruiting trials for Cervical Carcinoma

Currently open trials in the same condition.

Other Baylor College of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06686043.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing