Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Multicentric randomized phase I/IIa trial of the safety and immunogenicity of a therapeutic HPV DC targeting vaccine in patients with Human papillomavirus (HPV)-positive oropharyngeal cancer (HPV.DCVax)

This research is a trial for a new type of vaccine designed for individuals with throat cancer, specifically a type caused by the Human Papillomavirus (HPV). The main goals are to find out if this vaccine is safe for people and if it can help their immune system recognise and fight the cancer cells. Researchers hope that by boosting the body's natural defences, this vaccine could reduce the risk of the cancer returning after initial treatment. This is an early stage study, meaning it's one of the first times this vaccine is being tested in people to see how it works and whether it is safe.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Institut Gustave Roussy

Enrolment target

Start

18 Jul 2023

reduced risk of relapse of HPV-related oropharyngeal squamous cell carcinoma

What is this study about?

This study is looking into a new kind of treatment, a therapeutic vaccine, for people who have throat cancer caused by the Human Papillomavirus (HPV). You might already know about HPV vaccines given to young people to prevent infections; however, this is different. This vaccine is designed for people who *already have* HPV-related throat cancer. It's meant to teach the body's own defence system (called the immune system) to better attack and get rid of cancer cells.

The main idea behind this vaccine is to help reduce the chance of the cancer coming back after standard treatments have been completed. Researchers want to see if strengthening the immune response against the cancer could offer a longer-lasting effect. Early stage trials like this one are very important for understanding how new treatments work and if they are safe for people.

This trial is in its early stages (Phase I and IIa), which means it's one of the first times this specific vaccine is being given to people. Researchers will be carefully checking how safe it is and how well it helps the immune system respond to the HPV-related cancer. The information gathered from this study will help decide if this vaccine has the potential to become a new treatment option in the future.

Key takeaways

This study is for adults with HPV-related throat cancer.
It's testing a new vaccine to help the immune system fight cancer.
The main goals are to check the vaccine's safety and how the immune system responds.
It's an early-stage trial, so results are not guaranteed, but could reduce cancer recurrence.
Participation involves vaccine doses, medical checks, and follow-up appointments.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. Both men and women can take part.

More detailed checks will be done by the study team, but generally, participants will have been diagnosed with a specific type of throat cancer (oropharyngeal cancer) that has been caused by the Human Papillomavirus (HPV).

You will need to meet other specific health requirements that the study doctors will explain. These are in place to make sure that the study is safe for you and that the results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have throat cancer that has been linked to HPV?
Are you able to attend regular hospital or clinic appointments?
Are you generally well enough to take part in a clinical study?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a series of visits to the hospital or clinic. During these visits, you would receive the study vaccine. The team would also carry out various tests, such as blood tests and possibly other scans, to check on your health and how your body is responding to the vaccine. There would be follow-up appointments over a period of time to monitor your progress and check for any side effects.

The total length of your participation would depend on the study's plan, but early-stage trials often involve follow-up over several months to a year or more. All aspects of your involvement, including the number of visits, tests, and the total duration, would be fully explained to you before you decide to take part.

Potential risks and benefits

There are potential benefits to taking part in this study, as you would be among the first to receive a new vaccine that *might* help reduce the risk of your cancer returning. However, as this is an early-stage trial, it's important to remember that the benefits are not guaranteed. There are also potential risks; the vaccine might cause side effects, some of which could be unexpected or serious. All known risks would be fully explained to you, and your health would be closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is HPV and how does it relate to throat cancer?

HPV is a very common virus. Certain types of HPV can cause cells to change, leading to some cancers, including a type of throat cancer called oropharyngeal cancer.

Is this vaccine to prevent HPV or treat cancer?

This vaccine is different from the preventative HPV vaccine. It's a 'therapeutic' vaccine, meaning it's designed to help *treat* people who already have HPV-related throat cancer.

What does 'Phase I/IIa' mean for a study?

These are early stages of testing. Phase I mainly checks safety and dosage, while Phase IIa looks at safety and if the treatment shows signs of working in a small number of people.

Will I still receive my usual cancer treatment?

This vaccine is intended to be used alongside or after standard cancer treatments. The study team will explain how it fits with your overall care plan.

What if I experience side effects?

The study team will closely monitor you for any side effects. You should always tell them about any new or worsening symptoms you experience during the trial.