Active not recruitingPHASE3INTERVENTIONAL

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

This study is looking into a new treatment for bladder cancer that has grown into the muscle, but hasn't spread further. This type of cancer is called muscle-invasive bladder cancer (MIBC). The study compares a new drug combination, enfortumab vedotin (EV) and pembrolizumab, with the usual chemotherapy treatment (gemcitabine and cisplatin). Both treatments are given before major surgery to remove the bladder and nearby lymph nodes. Researchers want to find out if the new combination is better at preventing the cancer from coming back and if it is safe for patients. This is for people who can have cisplatin chemotherapy.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

808

Start

21 Apr 2021

Estimated completion

18 May 2028

Bladder Cancer

What is this study about?

This study is a research project designed to help people with a type of bladder cancer that has spread into the muscle wall, but not to distant parts of the body. This is called 'muscle-invasive bladder cancer' (MIBC). Bladder cancer can be a very serious condition, and doctors are always looking for better ways to treat it and stop it from coming back.

Currently, many patients with MIBC who are strong enough will receive chemotherapy, usually a combination of drugs called gemcitabine and cisplatin, before having major surgery. This surgery involves removing the bladder (called a 'radical cystectomy') and some nearby lymph nodes (small glands that are part of your immune system). This study wants to see if a newer approach using two different drugs, enfortumab vedotin and pembrolizumab, given before surgery, works better than the standard chemotherapy. Both groups of patients in the study will still have the same major surgery afterwards.

Enfortumab vedotin and pembrolizumab work in different ways to fight cancer. Enfortumab vedotin is a targeted drug that delivers chemotherapy directly to cancer cells. Pembrolizumab helps your body's own immune system find and kill cancer cells. By comparing these new drugs to the standard treatment, doctors hope to find out if this new combination can more effectively prevent the cancer from returning, which is a very important goal in treating bladder cancer.

Key takeaways

This study compares a new drug combination with standard chemotherapy for muscle-invasive bladder cancer.
Both treatments are given before major surgery to remove the bladder.
The new drugs aim to reduce the chance of cancer returning.
Eligibility depends on your specific cancer type, overall health, and kidney function.
You will be closely monitored if you take part.

Who may be eligible?

To be considered for this study, you would generally need to have bladder cancer that has gone into the muscle but hasn't spread to other distant parts of your body. Doctors will confirm this using tests like scans. You also need to be well enough to have the planned surgery to remove your bladder and be able to receive cisplatin chemotherapy, which means your kidneys and other organs need to be working adequately.

There are also some reasons why you might not be able to join. For example, if you have another ongoing cancer that needs active treatment, or if you've already had certain types of anti-cancer treatments for your bladder cancer in the past. You also can't have serious heart problems, certain ongoing nerve issues, or uncontrolled infections like HIV or hepatitis. Your doctors will review your full medical history 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 I have bladder cancer that has spread into the muscle, but not elsewhere?
Am I generally well enough for major surgery?
Are my kidneys and other organs working properly, making me eligible for cisplatin chemotherapy?
Have I not had certain anti-cancer treatments for bladder cancer in the past?
Do I have a good overall health status (ECOG 0 or 1)?
Do I have an active additional cancer that needs treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups. One group will receive the new drug combination (enfortumab vedotin plus pembrolizumab) and the other will receive the standard chemotherapy (gemcitabine and cisplatin). Both treatments are given over several cycles before your planned surgery to remove your bladder and nearby lymph nodes.

You will have regular appointments for your treatments, blood tests, and scans to check how you are responding and to monitor for any side effects. After your surgery, you will continue to have follow-up appointments, which may include scans and check-ups, for a period to see how you are doing in the long term. The exact number of visits and the total length of time you are followed will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial like this offers potential benefits, such as access to new and potentially more effective treatments before they are widely available. Your health will also be closely monitored by medical experts. However, there are also potential risks involved. The treatments, both the new drugs and standard chemotherapy, can cause side effects, which can vary from mild to severe, and may be different from person to person. As with any clinical trial, there's no guarantee that the new treatment will be more effective than the standard care. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (188)

Mayo Clinic in Arizona - Phoenix ( Site 0043)
Verified postcode
Phoenix, United States
St Joseph Heritage Healthcare-Oncology ( Site 0035)
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Fullerton, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0005)
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Los Angeles, United States
University of California San Francisco ( Site 0010)
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San Francisco, United States
Stanford University ( Site 0023)
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Stanford, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0009)
Verified postcode
Aurora, United States
UF Health ( Site 0031)
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Gainesville, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)
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Indianapolis, United States
University of Iowa Hospital and Clinics ( Site 0029)
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Iowa City, United States
University of Louisville, James Graham Brown Cancer Center ( Site 0022)
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Louisville, United States
Icahn School of Medicine at Mount Sinai ( Site 0011)
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New York, United States
White Plains Hospital ( Site 0039)
Verified postcode
White Plains, United States

Common questions

What is 'muscle-invasive bladder cancer'?

This is a type of bladder cancer where the cancer cells have grown into the muscular wall of your bladder.

What does 'perioperative' mean?

It means the treatment is given both before and around the time of your surgery.

What are enfortumab vedotin and pembrolizumab?

These are two different anti-cancer drugs. Enfortumab vedotin targets cancer cells, and pembrolizumab helps your immune system fight the cancer.

What is 'radical cystectomy and pelvic lymph node dissection'?

This is a major surgery to remove your bladder and some of the lymph nodes (small glands) from your pelvis.

Will I definitely get the new drugs if I join?

No, you will be randomly assigned to either the new drug combination or the standard chemotherapy. You won't get to choose.