AuthorisedTherapeutic exploratory (Phase II)Interventional

Maintenance AVElumab after SECond line platinum-based chemotherapy for metastatic urothelial carcinoma: AVESEC trial - GOIRC-02-2025

This study, called AVESEC, is testing a new treatment called avelumab for a type of bladder cancer that has spread, known as metastatic urothelial carcinoma. This cancer has usually been treated with a first round of chemotherapy, and this study looks at what happens next. The aim is to see if avelumab, given after initial chemotherapy, is better than simply watching and waiting, or other standard treatments, in helping patients live longer and feel better. Researchers will be checking how the cancer responds, if it grows, and how patients' general health and quality of life are affected. It's an important step to find more effective ways to manage this condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Enrolment target

144

Start

12 May 2026

metastatic urothelial carcinoma

What is this study about?

This study, called the AVESEC trial, is looking into a new treatment for a specific type of cancer called metastatic urothelial carcinoma. This is a type of bladder cancer that has spread to other parts of the body. Often, people with this kind of cancer will have already had an initial course of chemotherapy. The study wants to find out if giving a treatment called avelumab after this first round of chemotherapy helps patients more than current approaches.

Think of it as a follow-up plan. After the first heavy round of treatment, doctors want to know if there's a better next step. Avelumab is a type of immunotherapy, which helps your body's own immune system fight cancer. The researchers will be carefully comparing how patients receiving avelumab do compared to those receiving other standard care. They will examine how long people live, whether their cancer stays under control, and how their quality of life is affected.

This is a Phase II study, which means it's an earlier stage investigation. These types of studies are crucial for gathering more information about new treatments, checking their safety, and seeing if they show enough promise to be studied in larger groups of people. The goal is always to find better ways to help people with cancer live longer and with a better quality of life.

Key takeaways

This study is for a type of bladder cancer that has spread.
It tests a treatment called avelumab after initial chemotherapy.
The aim is to see if avelumab improves length of life and quality of life.
It's an early-stage study to gather more information about the treatment.
Your health and well-being will be closely monitored throughout.

Who may be eligible?

To be considered for this study, you would typically need to be an adult, aged 18 or older. Both men and women can take part.

The study is specifically for people who have been diagnosed with metastatic urothelial carcinoma. This means you have a type of bladder cancer that has spread to other parts of your body. Also, you must have already completed a main course of chemotherapy for your cancer.

Further checks will be done by the study team to make sure it's safe and appropriate for you to join. For example, they will look at your general health, other medical conditions, and how your body has responded to previous treatments.

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 metastatic urothelial carcinoma (bladder cancer that has spread)?
Have you already completed a first round of chemotherapy for your cancer?
Are you able to attend regular clinic appointments and follow study procedures?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the study drug, avelumab, which is given by drip (intravenously). The doctors and nurses would regularly check your health, how the cancer is responding, and any side effects you might experience. This would involve regular visits to the clinic, which will likely include physical examinations, blood tests, and scans to monitor your cancer.

You would also be asked to complete questionnaires about your symptoms, how you are feeling, and your general quality of life. These questionnaires help the researchers understand how the treatment affects your daily life from your perspective. The total duration of your participation, including follow-up, would be discussed in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than current options, though this is not guaranteed. However, avelumab, like any medication, can have side effects, and these would be carefully explained to you by the study team. 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
Italy

Common questions

What type of cancer is this study for?

This study is for metastatic urothelial carcinoma, which is a type of bladder cancer that has spread.

What is avelumab?

Avelumab is an immunotherapy drug that helps your body's immune system fight cancer.

Do I have to pay to be in the study?

No, all study-related treatments and tests are provided at no cost if you choose to participate.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care.

Is this a new treatment?

Avelumab is an existing treatment; this study is looking at using it in a specific situation after initial chemotherapy for this type of cancer.