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NCT06686043: HPV-VIM
HPV Vaccine, Imiquimod, and Metformin Combination Trial
Phase 2 trial testing HPV vaccine, Imiquimod, and metformin combination therapy in Cervical Carcinoma in 85 participants. Currently enrolling.
23 August 2026
Quick facts
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 85 |
| Start date | 23 August 2024 |
| Primary completion | 23 August 2026 |
| Estimated completion | 23 August 2028 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- HPV vaccine, Imiquimod, and metformin combination therapy — full drug profile →
Conditions studied
- Cervical Carcinoma — all drugs for Cervical Carcinoma →
- Vaginal Carcinoma — all drugs for Vaginal Carcinoma →
- Vulvar Carcinoma — all drugs for Vulvar Carcinoma →
- HPV (Human Papillomavirus)-Associated Carcinoma — all drugs for HPV (Human Papillomavirus)-Associated Carcinoma →
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):
-
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 -
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:
- PubMed search for NCT06686043
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Carcinoma
Currently open trials in the same condition.
- NCT07407647 — Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer · Phase 2 · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT07281430 — Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04) · NA · recruiting
- NCT06804135 — Systemic and Tumor Immune Response During Pelvic (Chemo)Radiation and/or Brachytherapy for Cervical Cancer · recruiting
- NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
Other Baylor College of Medicine trials
Trials by the same sponsor.
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- NCT05855824 — Toddler Biomarker of Nutrition Study · NA · not yet recruiting
- NCT06738628 — Disposable Endoscope Platform in Third Space Endoscopic Procedures · not yet recruiting
- NCT06834997 — Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital · Phase 2 · withdrawn
- NCT07387614 — WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06686043 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
- Last refreshed: 13 November 2024
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