A trial looking at immunotherapy for vulval intraepithelial neoplasia (VIN)

Cancer type:

Vulval cancer




Phase 2

This trial was looking at a combination of two treatments for vulval intraepithelial neoplasia (VIN). VIN is not cancer, but there are pre cancerous changes in the skin cells. This may eventually become vulval cancer if it is not treated.

Treatment for VIN is usually surgery or possibly laser treatment to remove the area of abnormal cells. Sometimes women need to have treatment more than once.

In this trial the researchers were looking at a combination of 2 types of immunotherapy Open a glossary item. The treatments help the immune system to kill abnormal cells. One treatment was a cream called imiquimod that was applied to the vulva. The other was a vaccination Open a glossary item against the HPV virus.

Researchers hoped that this combination of treatments would help women with vulval intraepithelial neoplasia.

The aims of the trial were to find out

  • How well this combination of treatments worked for VIN
  • What effect the treatment had on the immune system
  • More about the side effects

Summary of results

The researchers found that the treatment helped some of the women in this trial.

The trial recruited women who had VIN2 or VIN3. Their average age was 46. About two thirds of the women had already had treatment for VIN and half of those women had already had at least 3 other treatments.

All the women had imiquimod cream for 8 weeks, followed by 3 HPV vaccinations.

Out of 19 women that the researchers have results for, VIN had disappeared

  • In 6 women (32%) after 10 weeks
  • In 11 women (58%) after 20 weeks
  • In 12 women (63%) after 52 weeks

The side effects during the weeks they had imiquimod cream included inflammation Open a glossary item or ulcers forming in the area where the cream was applied, as well as tiredness and flu like symptoms. There were no side effects associated with the HPV vaccinations.

From blood samples and biopsies Open a glossary item, the researchers were able to measure each woman’s immune response Open a glossary item. They found that women who had a good immune response were more likely to get rid of HPV infection and the VIN was more likely to disappear.

Is it not clear why some women didn’t respond very well. But as VIN disappeared in more than half the women in this small trial, the researchers suggest that there should be larger trials comparing immunotherapy with surgery to remove vulval intraepithelial neoplasia.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor H Kitchener

Supported by

University of Manchester
Wigan and District Cancer Research Committee

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 886

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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