Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)

NCT07735039 | Active Not Recruiting

• 1 other identifier: 2026/010.99/26/46
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.

Conditions

Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia (CIN); Low-Grade Squamous Intraepithelial Lesions

Keywords

High-risk HPV; HPV Clearance; Human Papillomavirus; İmmunomodulator; Vaginal Ovule; Cervical Dysplasia; ASC-US; LSIL; CIN1; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• HPV clearance rate

  The proportion of participants with a negative high-risk HPV test at the end of the 3-month treatment period.

  3 months

Secondary Outcomes (1)

• Cytological regression

  3 months

Other Outcomes (1)

• Treatment-related adverse events

  3 months

Study Arms (2)

Dual-Modality Immunotherapy

EXPERIMENTAL

Participants receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months.

Drug: Oral Immunomodulator; Drug: Vaginal Ovule

Standard Supportive Care

ACTIVE COMPARATOR

Participants receive standard supportive care for 3 months according to routine clinical practice.

Other: Standard Supportive Care

Interventions

Oral Immunomodulator DRUG

Oral immunomodulator administered twice daily for 3 months.

Dual-Modality Immunotherapy

Vaginal Ovule DRUG

Vaginal ovule administered for 14 consecutive days each month for 3 months.

Dual-Modality Immunotherapy

Standard Supportive Care OTHER

Standard supportive care according to routine clinical practice during the 3-month study period.

Standard Supportive Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants are biologically female because the study evaluates cervical HPV infection and cervical cytological lesions.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-65 years.
• Confirmed persistent high-risk human papillomavirus (HR-HPV) infection.
• Histologically confirmed CIN 1 or cytological diagnosis of ASC-US or LSIL.
• Eligible for conservative follow-up without immediate excisional treatment.
• Ability to provide written informed consent and comply with study procedures.

You may not qualify if:

• HSIL, CIN2, CIN3, adenocarcinoma in situ, or invasive cervical cancer.
• Pregnancy or breastfeeding.
• Immunodeficiency or current immunosuppressive therapy.
• Previous treatment for cervical dysplasia within the last 6 months.
• Planned colposcopy, cervical biopsy, or LEEP during the 3-month study period.
• Known hypersensitivity to any study intervention.
• Participation in another interventional clinical trial.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions; Atypical Squamous Cells of the Cervix

Interventions

Immunologic Factors

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors evaluating HPV test and cervical cytology results are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncology Fellow

Model Details: Participants are randomized in a 1:1 ratio to either dual-modality immunotherapy or standard supportive care and followed in parallel for three months.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): August 23, 2026
• Study Completion (Estimated): August 24, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

TU (1)