OncoMatch/Clinical Trials/NCT06686043
HPV Vaccine, Imiquimod, and Metformin Combination Trial
Is NCT06686043 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies HPV vaccine, Imiquimod, and metformin combination therapy for cervical carcinoma.
Treatment: HPV vaccine, Imiquimod, and metformin combination therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Disease stage
Required: Stage IB2-IVB (CERVICAL), II-IVB (VAGINAL), II-IVB (VULVAR)
histologically confirmed locally advanced or metastatic cervical carcinoma (Stage IB2-IVB), vaginal, or vulvar carcinoma (Stage II-IVB), AND not be considered a primary surgical candidate
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN; AST and ALT ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
adequate organ function within 28 days of registration, defined as follows: - Absolute neutrophil count ≥ 1,500/µL - Platelets ≥ 100,000/µL - Hemoglobin ≥ 9 g/dL - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN - Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor St. Luke's Medical Center- Dan L. Duncan Comprehensive Cancer Center · Houston, Texas
- Harris Health Smith Clinic · Houston, Texas
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