Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

This research study is investigating new treatment options for people with a specific type of early bladder cancer, called non-muscle-invasive bladder cancer (NMIBC). This is for patients whose cancer is considered high-risk and has not improved after standard treatment with a medicine called Bacillus Calmette-Guerin (BCG). We are testing different new medicines, including one called pembrolizumab (also known as Keytruda), either by itself or combined with other experimental drugs. The main goals are to see how many people respond well to these treatments, how long they stay free of the disease, and to check for any side effects. We want to find safer and more effective ways to manage this type of bladder cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

102

Start

13 Jul 2023

Non-Muscle Invasive Bladder Cancer (NMIBC)

What is this study about?

This study focuses on a type of bladder cancer called non-muscle-invasive bladder cancer (NMIBC). This means the cancer is only in the inner lining of your bladder and hasn't grown into the deeper muscle. However, for some people, even this early stage of bladder cancer can be serious and is considered 'high-risk' because it has a higher chance of coming back or spreading. The usual treatment for this type of high-risk NMIBC is a drug called BCG, which is put directly into the bladder. But sometimes, BCG doesn't work, or the cancer comes back shortly after.

When BCG treatment isn't successful, doctors need other options. That's where this study comes in. We are looking at new medicines, including one called pembrolizumab (also known as Keytruda), which is a type of immunotherapy. Immunotherapy helps your own body's immune system fight cancer cells. We are testing pembrolizumab alone or in combination with other new experimental drugs (MK-7684A and MK-4280A) to see if they can effectively shrink the cancer or keep it from coming back in people whose high-risk NMIBC didn't respond to BCG.

The main aims of this study are to find out if these new treatments can make the cancer disappear completely (which we call a 'complete response') and how long patients stay free of the disease. We also carefully monitor all participants for any side effects or unwanted reactions to the medicines. By doing this research, we hope to find new and better ways to treat this challenging form of bladder cancer, offering more hope to patients when standard treatments haven't worked.

Key takeaways

This study is for high-risk early bladder cancer that hasn't responded to standard BCG treatment.
It's testing immunotherapies like pembrolizumab (Keytruda), alone or with other new drugs.
The main aims are to see how well these treatments work and if they are safe.
Participation involves regular clinic visits for treatment and monitoring.
You could access a new treatment option, but there's a possibility of side effects.

Who may be eligible?

To join this study, you generally need to be at least 18 years old – there's no upper age limit.

This study is for people who have been diagnosed with a specific type of bladder cancer called high-risk non-muscle-invasive bladder cancer (NMIBC). This means the cancer is in the inner lining of your bladder, but it's considered serious enough to need careful attention. A key requirement is that your cancer must not have improved after previous treatment with BCG. That means the BCG treatment either didn't work at all, or your cancer came back or got worse after receiving it.

Both men and women can take part in this study. The healthcare team running the study will check many other factors, including your general health and other medical conditions you might have, to make sure this study is safe and suitable for you. They will explain all the requirements in detail.

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 high-risk non-muscle-invasive bladder cancer?
Has your bladder cancer not responded to previous BCG treatment?
Are you generally well enough to take part in a study?
Are you able to travel to regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given one of the new study medicines, such as pembrolizumab, either by itself or with another experimental drug. These medicines are usually given as an infusion (drip) into your vein at regular intervals. You will have regular visits to the clinic to receive your treatment, and the study team will carry out various tests, like urine tests, blood tests, and imaging scans (such as MRI or CT scans), to monitor your health and see how the treatment is working. They will also ask you about any side effects you might be experiencing. The total length of your participation will depend on how you respond to the treatment and the specific group you are in, but these types of studies often involve several months to a couple of years of treatment and follow-up.

Potential risks and benefits

Taking part in this study means you could be among the first to benefit from a new treatment for your bladder cancer, especially if standard options haven't worked. However, there are potential risks, as new medicines can have side effects, which might be mild or more serious – the study team will explain these thoroughly. While we hope the treatment will help, there's no guarantee it will work for everyone, and it might not be better than other options. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

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

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Unverified
Finland
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Unverified
Greece
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Unverified
Netherlands
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Unverified
Sweden
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Unverified
Spain
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Unverified
France
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Unverified
Italy

Common questions

What is 'non-muscle-invasive bladder cancer'?

It's a type of bladder cancer that has only grown into the inner lining of your bladder and hasn't spread into the deeper muscle layer.

What does 'BCG unresponsive' mean?

It means the standard treatment, BCG, either didn't work for your bladder cancer, or the cancer came back or got worse after you had BCG.

What is pembrolizumab (Keytruda)?

It's a type of immunotherapy that helps your body's own immune system find and fight cancer cells.

What is the main goal of this study?

The main goals are to see how effective these new treatments are at getting rid of the cancer or keeping it away, and to monitor for any side effects.

Will I receive a placebo?

No, this study is testing active drugs. You would receive one of the new experimental treatments.