Active not recruitingPHASE2INTERVENTIONAL

A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy

This research study is testing a new medicine called avelumab for men aged 18 and over who have advanced penile cancer. This means the cancer has spread or cannot be removed by surgery. The study is for those who are not well enough for, or whose cancer has continued to grow despite, standard platinum-based chemotherapy. Avelumab works by blocking certain proteins that cancer cells use to hide from the body's immune system. By blocking these proteins, we hope the immune system can better find and fight the cancer. The main goal is to see if avelumab can shrink the tumours.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

15 Aug 2018

Estimated completion

31 Dec 2026

Penile Cancer Advanced Cancer Metastatic Cancer

What is this study about?

This study is investigating a new treatment called avelumab for a type of cancer called penile cancer. Penile cancer is a rare cancer that affects the penis. This study focuses on men whose penile cancer is considered advanced, meaning it has either spread to other parts of the body (metastatic) or is too widespread to be removed by surgery (locally advanced).

Standard treatment for advanced penile cancer often includes chemotherapy using platinum-based drugs. However, not everyone can have this chemotherapy, perhaps because they are not well enough, or for some, the chemotherapy eventually stops working and the cancer starts to grow again. This study is for these specific situations, offering a potential new option.

Avelumab is a type of drug called an immunotherapy. It works by targeting specific proteins on cancer cells and immune cells called PD-L1 and PD-1. Normally, these proteins act like a 'handshake' that tells the immune system to ignore the cancer. Avelumab blocks this handshake, which can help 'wake up' the immune system so it can recognise and fight the cancer cells. We're hoping this will lead to the tumours shrinking or stopping their growth.

Key takeaways

This study is for men with advanced penile cancer.
It's for those who can't have standard chemotherapy or whose cancer has grown despite it.
The drug, avelumab, is an immunotherapy that aims to boost your immune system to fight cancer.
The main goal is to see if avelumab can shrink tumours.
You'll get regular check-ups and supportive care throughout the study.

Who may be eligible?

To join this study, you must be a man aged 18 or older with penile cancer that has been confirmed by a biopsy. Your cancer needs to be advanced, meaning it cannot be removed with surgery or has spread. You also need to have measurable disease, which means doctors can see and track the size of your tumours.

Crucially, you must either be unable to receive standard platinum-based chemotherapy (perhaps due to other health conditions) OR your cancer must have continued to grow despite having already received this type of chemotherapy. You'll also need to be reasonably well enough to take part in the study, which doctors will assess.

There are some reasons you might not be able to join. For example, if you've already had certain types of other immunotherapy treatments, or if you've had major surgery recently. If you have some autoimmune diseases or have had an organ transplant requiring medication to suppress your immune system, you might also not be suitable for this study.

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 a man aged 18 or older?
Do you have a confirmed diagnosis of penile cancer that has spread or can't be removed by surgery?
Can doctors measure the size of your cancer?
Have you been told you can't have standard platinum-based chemotherapy, OR has your cancer grown even though you've already had it?
Are you generally well enough for a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive the investigational drug, avelumab, which is given as an infusion, typically through a vein. The exact schedule will be explained by the study team. You will have regular appointments with the study doctors for check-ups, blood tests, and scans to see how the treatment is working and monitor for any side effects. You'll also receive standard care to manage symptoms and support your well-being, known as Best Supportive Care. The total duration of your participation in the study will depend on how you respond to the treatment and will be discussed in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial like this could offer you access to a new treatment that isn't widely available yet, which might help to shrink or control your cancer. However, there's no guarantee the treatment will work for you, and it may have side effects, some of which could be serious. The study team will explain all known and potential risks in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What is penile cancer?

Penile cancer is a rare type of cancer that develops on the skin or in the tissues of the penis.

What is avelumab and how does it work?

Avelumab is an immunotherapy drug that helps your body's own immune system find and fight cancer cells by blocking certain proteins that cancer uses to hide.

What does 'unfit for platinum-based chemotherapy' mean?

It means your doctors believe that the side effects of standard platinum chemotherapy would be too severe for you, or there are other health reasons preventing you from safely receiving it.

Will I still receive care for my symptoms if I join?

Yes, you will receive 'Best Supportive Care', which means doctors and nurses will help manage any symptoms you have and support your overall well-being during the study.

How long will I be on the study drug?

The length of treatment will vary for each person, depending on how your body responds to the drug and if you experience any side effects. The study team will discuss this with you.