Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

(APOLLO)Neo-adjuvant Pembrolizumab in vulvar squamous cell carcinoma: a clinical proof-of-concept study

This research, called the APOLLO study, is exploring a new treatment approach for vulvar squamous cell carcinoma, a type of cancer affecting the vulva. The study involves giving a drug called Keytruda before surgery. Researchers want to see if Keytruda can effectively shrink the cancer tumours. They are also investigating how this drug affects specific immune cells within the tumour, hoping to understand how it helps the body fight the cancer. This is a Phase II study, meaning it's an earlier stage of drug testing to find out if the treatment works and is safe. The main goal is to measure changes in tumour size and look at how certain immune cells behave after treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

10 Sep 2024

Vulvar squamous cell carcinoma

What is this study about?

This study, called APOLLO, is looking into new ways to treat a type of cancer called vulvar squamous cell carcinoma. This cancer affects women, developing on the outer parts of the female genitals (the vulva). Doctors often treat this cancer with surgery, but this study wants to see if giving a medicine called Keytruda before surgery could make a difference.

Keytruda is a type of drug that works with your body's immune system to help it fight cancer. The researchers want to find out if giving Keytruda before surgery can shrink the tumour, making the surgery potentially easier or more effective. They will also be carefully watching how this drug affects certain immune cells inside the tumour, trying to understand exactly how it works.

This is an important step in finding better treatments for vulvar squamous cell carcinoma. By understanding how Keytruda works before surgery, doctors hope to improve the outcomes for women with this condition. The study will look at how much the tumour shrinks and if the normal and cancer cells respond differently.

Key takeaways

Tests Keytruda before surgery for vulvar cancer.
Aims to shrink tumours and understand immune response.
For adult women with vulvar squamous cell carcinoma.
Involves infusions, regular check-ups, and scans.
Could offer new treatment options in the future.

Who may be eligible?

To take part in this study, you must be an adult woman, at least 18 years old, who has been diagnosed with vulvar squamous cell carcinoma. There are other specific medical requirements that your study doctor will check.

This study is specifically for women with this type of cancer. The medical team will carefully review your health information to make sure the study is a good fit for you and that it's safe for you to participate.

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 an adult aged 18 or over?
Are you female?
Have you been diagnosed with vulvar squamous cell carcinoma?
Are you able to attend appointments and receive infusions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, Keytruda, as an infusion (through a drip into your vein) before your planned surgery. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to see how your tumour is responding to the treatment. The research team will also collect tissue samples. You'll be closely monitored for any side effects throughout the treatment period and during your follow-up after surgery. The total length of your participation would depend on your specific treatment plan and follow-up schedule.

Potential risks and benefits

Potential benefits of taking part could include receiving a new treatment that might shrink your tumour before surgery, which could improve your surgical outcome. You would also be closely monitored by a medical team. However, as with any medical treatment, there are potential risks and side effects from Keytruda, which your study doctor will explain in detail. These can vary from person to person. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Netherlands

Common questions

What is vulvar squamous cell carcinoma?

It's a type of cancer that starts in the skin cells on the vulva, which is the outer part of the female genitals.

What is Keytruda?

Keytruda is a medicine that helps your body's immune system fight cancer cells. It's given as an infusion, like a drip.

What does 'neoadjuvant' mean?

It means the treatment (Keytruda, in this case) is given before the main treatment, which would be surgery in this study.

Will I still have surgery if I join this study?

Yes, the plan is to give you Keytruda before your planned surgery, not instead of surgery.

What is a Phase II study?

It's an early stage of research where doctors test if a new treatment works and is safe in a small group of people with the condition.