A PHASE I/II, OPEN-LABEL, DOSE ESCALATION AND EXTENSION STUDY OF INTRAVESICAL ECISKAFUSP ALFA IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) IN PARTICIPANTS WITH BCG-UNRESPONSIVE HIGH- RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
This research study is looking at a new way to treat a specific type of bladder cancer called 'high-risk non-muscle invasive bladder cancer' (NMIBC). This is for people whose cancer hasn't been helped by a common treatment called BCG. The study medicine, eciskafusp alfa, is given directly into the bladder using a thin tube, and it's combined with the BCG treatment. The main goals are to find out if this new combination is safe, what the right dose is, and how well it helps control the cancer. The study is divided into phases: an early phase to check safety and dosing, and a later phase to see how many people have their cancer go away or shrink. This approach aims to offer a new option for patients with this difficult-to-treat bladder cancer.
At a glance
What is this study about?
This study is designed for individuals who have a specific type of bladder cancer called 'high-risk non-muscle invasive bladder cancer' (NMIBC). 'Non-muscle invasive' means the cancer is only in the inner lining of the bladder and hasn't grown into the deeper muscle layers. 'High-risk' means it's more likely to come back or get worse. Crucially, this study is for people whose cancer hasn't responded well to a standard treatment called BCG (Bacillus Calmette-Guérin). When bladder cancer doesn't respond to BCG, doctors often call it 'BCG-unresponsive,' and it can be challenging to treat.
The main purpose of this study is to test a new combination treatment. This involves a medicine called eciskafusp alfa, which is given directly into your bladder (this is called 'intravesical'). It will be given alongside the BCG treatment. Researchers want to understand if this combination is safe and effective in helping to control the cancer. Think of it as exploring a potential new tool in the fight against this particular kind of bladder cancer when other treatments haven't worked.
The study has two main parts, Phase I and Phase II. Phase I is about finding the safest dose of the new treatment and identifying any side effects. Once a safe dose is determined, Phase II will focus on how well the treatment works in a larger group of people. The hope is that this new combination could offer a new and better option for patients facing BCG-unresponsive high-risk NMIBC.
Key takeaways
- This study evaluates a new treatment for high-risk bladder cancer that hasn't responded to standard BCG.
- The treatment involves a new medicine (eciskafusp alfa) given directly into the bladder, combined with BCG.
- The study aims to determine the treatment's safety, effective dose, and how well it makes the cancer disappear.
- It could offer a new option for individuals with difficult-to-treat bladder cancer.
- Close monitoring for side effects and cancer response is a key part of participating.
Who may be eligible?
To join this study, generally, you need to be at least 18 years old. Both men and women can take part. The most important requirement is that you have been diagnosed with 'high-risk non-muscle invasive bladder cancer' (NMIBC) and that your cancer has not gotten better or has come back after treatment with BCG (this is called being 'BCG-unresponsive').
There will be other detailed medical checks to make sure the treatment is suitable for you and that you are healthy enough to participate. For example, doctors will review your general health, how well your kidneys and liver are working, and whether you have any other serious medical conditions.
It's very important to discuss your full medical history with the study team. They will carefully assess all these factors to confirm if this study is the right fit for you.
- Are you 18 years old or older?
- Do you have high-risk non-muscle invasive bladder cancer (NMIBC)?
- Has your bladder cancer not responded to previous BCG treatment?
- Are you generally healthy enough to participate in a clinical trial?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will receive a combination of treatments: the new medicine called eciskafusp alfa and an existing treatment called BCG. Both medicines are given directly into your bladder using a thin tube. The study is designed to first find the safest dose of the new medicine (Phase I), and then to see how effective it is (Phase II). This means the exact number of visits and the duration of treatments might vary slightly depending on which part of the study you're in and how you respond.
You can expect regular visits to the clinic for your treatments and to have various assessments. These assessments will involve tests like blood and urine samples, physical examinations, and imaging scans to monitor your health and how your cancer is responding. The study team will track any side effects you might experience very closely.
After your initial treatment period, there will be follow-up visits over several months to continue monitoring your health, check for any return of the cancer, and track long-term effects. The total duration of your participation, including follow-up, could extend for several months, possibly up to a year or more, to gather thorough information on the treatment's safety and effectiveness.
Potential risks and benefits
Locations (7)
- —Italy
- —France
- —Netherlands
- —Poland
- —Denmark
- —Spain
- —Germany
Common questions
What is 'BCG-unresponsive' bladder cancer?
It means your bladder cancer has not gone away, or has come back and is progressing, even after receiving standard BCG treatment.
How is the study medicine given?
The medicines (eciskafusp alfa and BCG) are given directly into your bladder through a thin tube, which is common for bladder cancer treatments.
What is the main goal of this study?
The main goals are to find a safe dose for the new treatment combination and to see how well it helps to get rid of or control bladder cancer.
Will I get the new medicine?
Yes, if you qualify and join the study, you will receive the new medicine eciskafusp alfa along with BCG.
How long will I be in the study?
Participation duration varies, but typically involves a treatment period followed by several months of follow-up to monitor your health and response.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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