RecruitingPHASE2INTERVENTIONAL

Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer

This study is for people with advanced bladder cancer. It looks at whether having 3 cycles or 6 cycles of chemotherapy (gemcitabine plus cisplatin or carboplatin) is better before starting a treatment called avelumab. Avelumab is given as a 'maintenance' therapy afterwards. The main goal is to understand how these different treatment lengths affect a patient's quality of life. About 224 patients will take part. Patients will receive chemotherapy, followed by avelumab every two weeks for up to two years, unless their disease gets worse or side effects are too strong.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Queen Mary University of London

Enrolment target

320

Start

16 Dec 2021

Estimated completion

22 Dec 2027

Urinary Bladder Neoplasms

What is this study about?

If you have advanced bladder cancer that can't be removed by surgery, doctors are always looking for the best ways to treat it and help you live well. This study is designed to compare two different ways of starting treatment. Both ways involve standard chemotherapy, but one group will have 3 cycles (rounds) of it, and the other will have 6 cycles. After the chemotherapy, everyone in the study will receive a medicine called avelumab.

Avelumab is a type of treatment that helps your body's own immune system fight cancer. It's often given as a 'maintenance' therapy, meaning it's used to try and keep the cancer under control after initial treatment. The big question this study wants to answer is whether having more chemotherapy upfront (6 cycles) or less (3 cycles) makes a difference to your quality of life while still keeping the cancer in check when followed by avelumab.

By comparing these two approaches, researchers hope to find out which treatment plan leads to a better overall experience for patients, focusing on how you feel day-to-day. This information will help doctors decide the best way to use these treatments in the future for people with bladder cancer.

Key takeaways

This study compares 3 vs 6 cycles of chemo before avelumab for advanced bladder cancer.
The main goal is to see how each plan affects patients' quality of life.
Avelumab is an immunotherapy drug given after chemotherapy to help control cancer.
Participants will have regular visits, tests, and answer quality of life questions.
You can take part if you have advanced bladder cancer and are healthy enough for treatment.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have bladder cancer that has spread locally or to other parts of the body and cannot be removed by surgery. This includes cancers of the bladder, kidney, ureter, or urethra.

You would need to be well enough to receive the chemotherapy being tested and have your cancer measured. There are also specific checks to make sure your blood counts and organ functions (like kidney and liver) are working properly. If you are a woman who could get pregnant, you would need to have a negative pregnancy test and agree to use effective birth control during the study.

You wouldn't be able to join if you've already had a specific type of immune system drug called a PD-(L)-1 inhibitor for advanced cancer. However, if you had this type of drug in the past for bladder cancer surgery (neoadjuvant or adjuvant), you might still be able to join, as long as it's been more than 6 months since your last dose.

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 advanced bladder cancer that cannot be removed by surgery?
Are you well enough to receive chemotherapy and immunotherapy?
Have you NOT had a specific type of immunotherapy (PD-(L)-1 inhibitor) for advanced cancer before?
Are you willing and able to regularly complete questionnaires about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'd first be randomly assigned to one of two groups, like flipping a coin. One group will get 3 cycles of chemotherapy (gemcitabine plus cisplatin or carboplatin), and the other will get 6 cycles. A cycle usually lasts three weeks. After chemotherapy, both groups will receive avelumab every two weeks. You'll continue receiving avelumab for up to two years, or until your cancer gets worse, or if you can't tolerate the side effects.

Throughout the study, you would have regular hospital visits for your treatments, blood tests, and scans to check your cancer. You would also be asked to regularly fill out questionnaires about your quality of life. This helps researchers understand how the treatments are affecting you. The total length of your participation would depend on how long you receive avelumab, up to a maximum of two years after your chemotherapy finishes, plus any follow-up after that.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer monitoring of your condition and potentially receive a treatment plan that could improve your quality of life. However, chemotherapy and avelumab can have side effects, which your doctor will explain in detail. There's also no guarantee that the treatments will work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

Unicancer
Verified postcode
Paris, France· Recruiting
Adknoma
Verified postcode
Madrid, Spain· Enrolling by invitation
Barts Health NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'advanced urothelial cancer'?

This means cancer that affects the lining of your bladder or other parts of your urinary system, and it has either spread into the surrounding area or to other parts of your body, and cannot be removed by surgery.

What is chemotherapy, and what are cisplatin/carboplatin and gemcitabine?

Chemotherapy uses powerful drugs to kill cancer cells. Cisplatin, carboplatin, and gemcitabine are common chemotherapy drugs used to treat bladder cancer.

What is avelumab?

Avelumab is an immunotherapy drug that helps your body's immune system recognise and fight cancer cells. It's often given to help keep cancer under control after initial chemotherapy.

What does 'maintenance avelumab' mean?

After you finish your initial chemotherapy, 'maintenance' means you continue taking avelumab regularly to try and prevent the cancer from growing or coming back, rather than as a primary treatment.

Why are they looking at quality of life?

It's important to understand not just if a treatment works, but also how it affects your daily life, how you feel, and your ability to do things you enjoy. This helps doctors choose treatments that support your overall well-being.

How to find out more

DISCUS Trial Coordinator

bci-discus@qmul.ac.uk bci-discus@qmul.ac.uk Official trial record

Always speak to your GP or specialist before deciding to take part in a study.