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Vulvar Intraepithelial Neoplasia Grade 2Phase 1DelVINNCT05717621

Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)

A Phase 1 study testing VTD-101 ointment in people with Vulvar Intraepithelial Neoplasia Grade 2 and Vulvar Intraepithelial Neoplasia Grade 3, run by ViMREX GmbH at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicentre open labelled phase I trial evaluating the safety and preliminary efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar intraepithelial neoplasia (VIN) grade 2/3. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
VTD-101 ointment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesGermany
Study dates
28 Mar 2023to 17 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having provided written informed consent
  • Women ≥ 18 years of age at the time of signing the written informed consent
  • Women with histologically confirmed vulvar intraepithelial neoplasia (VIN) grade 2 or 3 (also referred to as "high grade VIN" or "high-grade squamous intraepithelial lesions [HSIL]")
  • Uni- or multifocal VIN grade 2 or 3
  • Newly diagnosed or recurrent VIN grade 2 or 3
  • Women who refuse standard therapy, have not responded (or no longer respond) to standard therapy, have not tolerated standard therapy or for whom standard therapy is contraindicated
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  • Evidence of HPV-induced etiology of the lesion(s) as indicated by the detection of p16INK4a overexpression as well as high-risk (HR) HPV DNA presence in the lesion(s)
  • Women of childbearing potential (WOCBP) must agree to use one highly effective contraceptive method during the treatment period and for at least 6 months after the last IMP administration
  • Ability of patient to understand the character and individual consequences of the clinical trial
  • In the investigator's judgement, is willing and able to comply with the study protocol

Who cannot join

  • Evidence for or suspicion of vulvar tumor invasion
  • History of vulvar cancer
  • Previous surgical (except biopsy) or medical procedures of the high-grade VIN within the past 4 weeks prior to treatment start
  • Neutropenia or thrombocytopenia
  • Known allergy or hypersensitivity against decitabine or any of the excipients contained in the formulation
  • Current or prior use of immunosuppressive medication within 14 days (3 months for azathioprine, methotrexate, and tofacitinib) before the first dose of VTD-101 ointment. The following are exceptions to this criterion:
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  • Intranasal, inhaled or topical (outside the anogenital area) steroids
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Medical conditions associated with severe immunosuppression (e.g., acquired immune deficiency syndrome [AIDS])
  • Active infection within the anogenital tract (except for HPV)
  • Malignancies within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastases or death (5-year OS > 90%) like ductal carcinoma in situ or basalioma
  • Evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the study medication, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results
  • Participation in another interventional clinical study ≤ 4 weeks prior to initiation of study treatment or participation in such a study at the same time as this study
  • Receipt of an investigational drug within 4 weeks prior to initiation of study treatment
  • Pregnancy or breast feeding or planning to become pregnant during the treatment period or during the 6 months following the end of treatment. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment
  • Women of childbearing potential who are unwilling to agree to remain abstinent (refrain from heterosexual intercourse) or to use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last IMP administration
  • Other study protocol-defined in-/exclusion criteria could apply.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Universitätsklinikum Augsburg, Klinik für Frauenheilkunde und Geburtshilfe

    Augsburg, Bavaria, 86156

  • St. Elisabeth Krankenhaus Köln, Klinik für Gynäkologie und Geburtshilfe

    Cologne, 50935

  • Frauenarztpraxis Heussweg Hamburg

    Hamburg, 20255

  • Dysplasiezentrum HH am Krankenhaus Jerusalem

    Hamburg, 20357

  • Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: The DelVIN Trial - A Multicenter Phase I Trial Evaluating the Safety and Preliminary Efficacy of Local Decitabine Treatment of Human Papillomavirus (HPV)-Induced Vulvar Intraepithelial Neoplasia (VIN) Grade 2/3

This is a multicentre open labelled phase I trial evaluating the safety and preliminary efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar intraepithelial neoplasia (VIN) grade 2/3.

The main purpose and primary objective of the study is to determine the recommended phase 2 dose (RP2D) of VTD-101 ointment for the topical treatment of HPV-induced VIN grade 2/3. The RP2D is defined as the dose that is safe, tolerable and effective. Corresponding endpoints are the rate of patients experiencing at least one dose limiting toxicity (DLT) and the rate of patients with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria.

Secondary objectives are to further characterize the efficacy of topical treatment with VTD-101 ointment, to further evaluate the safety and tolerability of topical treatment with VTD-101 ointment, and to evaluate quality of life (QoL) in patients treated with VTD-101 ointment.

Being tested
VTD-101 ointment
Keywords
vulvar intraepithelial neoplasia (VIN)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VTD-101 ointmentDrug

    Self-administration of VTD-101 ointment (Decitabine ointment)

Study groups in NCT05717621
Study groupRoleWhat they receive
Test ArmExperimentalVTD-101 ointment
Receives: Drug: VTD-101 ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the dose that is safe and tolerable (by the assessment of the rate of patients (%) experiencing at least one dose limiting toxicity (DLT)) as part of the determination of the recommended phase 2 dose (RP2D).

    The primary safety endpoint defined as rate of patients experiencing at least one DLT, will be identified by observing frequency, relation to IMP treatment and severity of specific AEs.

    Measured: 28 days

  2. Determination of the dose that is effective (by the assessment of the rate of patients (%) with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria) as part of the determination of the recommended phase 2 dose (RP2D).

    The primary efficacy endpoint is defined as proportion (%) of patients who achieved clinical complete or partial response, as assessed by adapted RECIST criteria. (Clinical complete response (cCR) is defined as: Complete visual disappearance of the treated lesion(s) (i.e., 100% reduction in the sum of the longest diameter (SLD) among all treated lesions). Clinical partial response (cPR) is defined as: 30-99% reduction in the SLD among all treated lesions.

    Measured: 16 months

Secondary outcomes (9)

  1. Rate of patients (%) with pathological complete response (pCR)

    The efficacy will be further characterized by the rate of patients experiencing a pathological complete response of the treated lesion(s) in percent (%).

    Measured: 4 months

  2. Computer-based read-out of clinical response

    The efficacy will be further characterized by a computer-based read-out of manually annotated total surface area of the lesions (mm2/cm2), which will be followed by grading according to adapted RECIST criteria (cCR: 100% reduction in lesion size, cPR: 30-99% reduction in lesion size, SD: 1-29% reduction in lesion size, PD: ≥20% increase in lesion size).

    Measured: 16 months

  3. Molecular response

    The efficacy will be further characterized by the molecular response defined as reduction of combined p16INK4a/Ki-67-positive cells within the lesion (or in the region of the initial location of the lesion in case of complete lesion disappearance) and defined as decrease of DNMT1 protein expression in HPV-transformed cells determined by immunohistochemistry.

    Measured: 4 months

  4. Clearance of HPV infection in the reference lesion

    The efficacy will be further characterized by the analysis of the clearance of HPV infection in the reference lesion, defined as the absence of HPV DNA of the HR-HPV type(s) detected at baseline.

    Measured: 4 months

  5. Disease recurrence in patients

    The efficacy will be further characterized by determining the presence of recurrent lesions in treated patients. Disease recurrence is defined as the reappearance of lesions that were previously subject to complete clinical response.

    Measured: 16 months

  6. Onset of new lesions

    The efficacy will be further characterized by determining the presence of new lesions in treated patients. Onset of new lesions is defined as the appearance of new lesion(s) at a distinct vulvar site (i.e., a site different from the treated site(s)).

    Measured: 16 months

  7. Adherence to the treatment plan assessed by drug accountability and patient diaries

    The efficacy will be further characterized by the adherence of patients to the treatment plan. This will be assessed by IMP drug accountability as well as by self-reporting by patients according to a standardized study-specific questionnaire (paper-based patient diary).

    Measured: 4 months

  8. Further evaluation of safety and tolerability of the treatment by the assessment of adverse events (AEs) according to NCI CTCAE v5.0

    The safety and tolerability of the treatment will be further assessed with the help of frequency tables with the number and percentage of patients who experienced the AE by treatment and total. Additionally, AEs will be summarized by seriousness of AE, relationship to the IMP, and grading for all NCI CTC categories (CTCAE v5.0).

    Measured: 16 months

  9. Evaluation of the quality of life (QoL) in patients treated with VTD-101 ointment with the help of the following corresponding endpoint: "VIN questionnaire" (QoL questionnaire modified and translated from [Lockhart et al. 2013]).

    QoL as assessed by means of 29 questions within the "VIN questionnaire" will be summarized using descriptive statistics and changes before and after treatment at respective time points by treatment and total.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start28 Mar 2023
  3. Primary completion17 Jan 2025
  4. Study completion17 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Clinical trial with a single arm (one-group), all eligible patients will receive treatment with VTD-101 ointment.
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05717621
Sponsor's protocol ID
V-001
Other IDs
2022-001834-12
Acronym
DelVIN
Status last verified
Feb 2025
First submitted
10 Jan 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VTD-101 ointment in people with Vulvar Intraepithelial Neoplasia Grade 2 and Vulvar Intraepithelial Neoplasia Grade 3, run by ViMREX GmbH at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the dose that is safe and tolerable (by the assessment of the rate of patients (%) experiencing at least one dose limiting toxicity (DLT)) as part of the determination of the recommended phase 2 dose (RP2D). (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05717621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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