Active not recruitingPHASE2INTERVENTIONAL

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

This research study, called Duravelo-2, is looking into new ways to treat bladder cancer that has spread or is advanced. It is a worldwide study comparing a new medicine called zelenectide pevedotin, sometimes given with another drug called pembrolizumab, against standard chemotherapy treatments. We want to find out how effective these new treatments are at shrinking the cancer and if they cause any serious side effects. The study includes different groups of people: some who haven't had prior treatment for their advanced cancer, and others who have. This helps us understand which treatments might work best for different patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

BicycleTx Limited

Enrolment target

375

Start

24 Jan 2024

Estimated completion

01 Mar 2028

Metastatic Urothelial Cancer

What is this study about?

This study is for people in the UK and around the world who have bladder cancer that has either spread to other parts of the body (metastatic) or is advanced and can't be removed by surgery. Bladder cancer is when abnormal cells grow in the lining of the bladder. When it's advanced or metastatic, it can be challenging to treat, and doctors are always looking for better options to help patients.

The main goal of this study is to test a new medicine called zelenectide pevedotin. Researchers want to see if this new drug, either on its own or given with another medicine called pembrolizumab, works better and is safer than the usual chemotherapy treatments. By comparing these different approaches, doctors hope to find more effective ways to fight this type of cancer and improve patients' lives.

The study is designed in two main groups. One group will be for people who haven't had treatment for their advanced bladder cancer before. The other group will include patients who have already had at least one treatment. This allows researchers to understand how the new treatments work at different stages of the disease and for patients with different treatment histories. This information is really important for developing future cancer therapies.

Key takeaways

This study is testing new treatments for advanced or metastatic bladder cancer.
It compares a new drug (zelenectide pevedotin) alone or with pembrolizumab against standard chemotherapy.
The study includes people who have, and haven't, had previous treatments for their advanced cancer.
It aims to find out how effective and safe these new treatments are.
Participation involves regular hospital visits for treatment, tests, and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have been told by your doctor that you have bladder cancer that is advanced or has spread. You would also need to be well enough to take part and expected to live for at least 12 weeks. Doctors will need to be able to measure your cancer, for example, on scans, to see if the treatment is working. They will also need to review some tissue from your cancer.

If you haven't received any treatment for your advanced bladder cancer yet, you might be in the first group, provided you are suitable for standard chemotherapy. If you have already had at least one treatment for your advanced bladder cancer, you might be suitable for the second group, especially if your cancer has grown or come back after your last treatment.

Some things that might prevent you from joining include certain eye problems like active keratitis or corneal ulcers, or if you need to take certain medications that could interfere with the study drugs. If you are a woman who could become pregnant, you would need to have a negative pregnancy test. Your doctor will carefully check all the requirements to see if this study is right for you.

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 at least 18 years old?
Has your doctor told you that you have advanced or metastatic bladder cancer?
Can your cancer be measured (e.g., on a scan)?
Are you well enough to participate in a clinical study?
Have you not had any active eye conditions like keratitis or corneal ulcers?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the study treatments: either the new drug zelenectide pevedotin (alone or with pembrolizumab) or standard chemotherapy (gemcitabine plus cisplatin or carboplatin, or avelumab). You would have regular appointments at the hospital for treatments, blood tests, scans, and check-ups to monitor your health and how the treatment is working. Doctors would also ask about any side effects you might be experiencing.

The study involves several visits over time, typically for as long as the treatment is helping you and you are tolerating it well. There would be a follow-up period after finishing treatment to continue monitoring your health. The total duration of your involvement in the study would depend on how your cancer responds to treatment and how you are feeling, but it would involve a commitment to regular hospital visits and assessments.

Potential risks and benefits

Taking part in this study might offer you access to new treatments before they are widely available. If these new treatments are effective, they could potentially help shrink your cancer or slow its growth. However, like all medicines, the study drugs can have side effects, which could be mild or serious. The study team will explain all known risks and carefully monitor you throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (102)

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

Rocky Mountain Cancer Center
Verified postcode
Denver, United States
University of Miami - Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States
Mount Sinai Medical Center of Florida, Inc.
Verified postcode
Miami Beach, United States
Moffitt
Verified postcode
Tampa, United States
University of Kansas Cancer Center
Verified postcode
Westwood, United States
UofL Health Brown Cancer Center
Verified postcode
Louisville, United States
Nebraska Cancer Specialists
Verified postcode
Omaha, United States
Montefiore Medical Center
Verified postcode
The Bronx, United States
Medical University of South Carolina (MUSC) - Hollings Cancer Center
Verified postcode
Charleston, United States
Carolina Urologic Research Center
Verified postcode
Myrtle Beach, United States
SCRI Oncology Partners
Verified postcode
Nashville, United States
MD Anderson Cancer Center
Verified postcode
Houston, United States

Common questions

What is 'urothelial cancer'?

Urothelial cancer is the most common type of bladder cancer, but it can also occur in other parts of the urinary system like the kidneys or urethra.

What does 'metastatic' mean?

'Metastatic' means the cancer has spread from where it started to other parts of the body.

What is 'chemotherapy'?

Chemotherapy is a type of cancer treatment that uses powerful drugs to kill fast-growing cancer cells in the body.

Will I know which treatment I am getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know which specific treatment you are receiving.

How long will I be on the study treatment?

You will typically continue treatment for as long as it is helping your cancer and you are tolerating it well, as decided by your study doctor.