Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

This study is exploring a new way to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). This type of cancer is found in the lining of the bladder but hasn't spread to the muscle. "High-risk" means it might be more likely to worsen or return. Researchers want to see if combining a new drug, pembrolizumab, with a standard treatment called BCG works better than BCG alone. They will check if this combination helps more people stay cancer-free for longer and if it's safe and tolerable. Your participation could help us learn more about better treatments for this condition.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

1,397

Start

24 Dec 2018

Estimated completion

20 Nov 2034

High-risk Non-muscle Invasive Bladder Cancer

What is this study about?

Imagine your bladder has a lining, and sometimes, cells in this lining can become cancerous. When this cancer hasn't grown into the bladder muscle itself, doctors call it "non-muscle invasive bladder cancer." If this type of cancer is described as "high-risk," it means there's a higher chance it might come back or get worse, even after treatment. It's a bit like having a stubborn weed in your garden that keeps trying to grow back.

Currently, one common treatment for this is called BCG. It's a type of immunotherapy that helps your body's immune system fight the cancer. This study is looking at whether adding another drug called pembrolizumab to BCG could make the treatment even more effective. Pembrolizumab also works by helping your immune system, but in a different way, to recognise and attack cancer cells.

The main aim is to see if combining these two treatments means more people can get rid of their cancer completely, and whether they stay cancer-free for a longer time compared to those who just receive BCG. The researchers will also be carefully watching to see if the combination treatment is safe and if people can handle any side effects well. Your involvement could play a significant role in improving future treatments for others facing this condition.

Key takeaways

This study investigates a new treatment option for high-risk non-muscle invasive bladder cancer.
It combines an existing treatment (BCG) with a newer drug (pembrolizumab).
The main aims are to improve cancer-free survival and assess safety.
Participation involves regular hospital visits for treatment and monitoring.
You might receive the new combination or the standard BCG treatment.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would generally need to have a specific type of bladder cancer called high-risk non-muscle invasive bladder cancer. This diagnosis needs to be confirmed by doctors. It's important that any visible tumours in your bladder have already been removed through an operation called a TURBT (transurethral resection of bladder tumour).

You'll also need to be fit enough for the study, usually meaning you can carry out most daily activities without too much difficulty. The research team will also check your organ functions, like your kidneys and liver, to make sure they are working well. For all participants, tissue samples will be needed for further testing.

There are also some reasons why people might not be able to join. For example, if your bladder cancer has already spread to the muscle or other parts of your body, or if you've had certain types of anti-cancer treatments recently. The study team will review all your medical information carefully 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.

Do you have high-risk non-muscle invasive bladder cancer, confirmed by your doctor?
Have all visible bladder tumours been removed by surgery (TURBT)?
Are you generally fit enough for daily activities?
Have you not had certain other anti-cancer treatments recently?
Is your cancer only in the bladder's lining and not spread to the muscle or other parts of your body?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving either BCG treatment alone or a combination of BCG and pembrolizumab. Both drugs are given directly into the bladder or through an injection, so you would have regular hospital visits for these treatments. These visits will likely include physical examinations, blood tests, and scans to monitor your health and how the treatment is working. You might also have further bladder examinations by a doctor (cystoscopies) to check for cancer.

The research team will provide you with a detailed schedule of visits and procedures. You will also be asked to report any side effects you experience. The total duration of your participation, including follow-up, will be explained fully by the study team, but can be for several years to track long-term outcomes. You will have regular contact with the study staff throughout this period.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination treatment proves to be more effective than current standard care in keeping your cancer at bay or preventing its return. However, it's also possible that the treatment may not work for you, or you might experience side effects. These could range from mild to more serious and will be explained in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (209)

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

Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
Verified postcode
Anchorage, United States
Mayo Clinic in Arizona - Phoenix ( Site 1094)
Verified postcode
Phoenix, United States
Del Sol Research Management, LLC ( Site 1096)
Verified postcode
Tucson, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 1052)
Verified postcode
Los Angeles, United States
University of California Irvine Medical Center ( Site 1061)
Verified postcode
Orange, United States
Genesis Research LLC ( Site 1065)
Verified postcode
Torrance, United States
Colorado Clinical Research ( Site 1100)
Verified postcode
Lakewood, United States
Urological Research Network ( Site 1106)
Verified postcode
Hialeah, United States
Mayo Clinic in Florida-Urology ( Site 1097)
Verified postcode
Jacksonville, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
Verified postcode
Miami, United States
Woodlands Medical Specialists, PA ( Site 8002)
Verified postcode
Pensacola, United States
Emory School of Medicine ( Site 1076)
Verified postcode
Atlanta, United States

Common questions

What is high-risk non-muscle invasive bladder cancer (HR NMIBC)?

It's a type of bladder cancer that's only in the liner of your bladder and hasn't spread to the muscle. 'High-risk' means it has a higher chance of coming back or getting worse.

What are pembrolizumab and BCG?

BCG is a standard treatment that helps your immune system fight bladder cancer. Pembrolizumab is a newer drug that also helps your immune system target cancer cells, but in a different way.

Why is this study combining these two treatments?

Researchers want to see if using both pembrolizumab and BCG together works better at keeping the cancer away than using BCG on its own.

Will I definitely get the new combined treatment?

Participants will be split into groups. Some will receive the combined treatment (pembrolizumab plus BCG), and others will receive BCG alone. You won't know which group you're in until after you join.

What are the main goals of this study?

The main goals are to find out if the combined treatment helps more people stay cancer-free for longer and to understand how safe and tolerable the treatments are.