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Active not recruitingPHASE3INTERVENTIONAL

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

This study is investigating new treatment options for people with muscle-invasive bladder cancer, a type of bladder cancer that has grown into the bladder's muscle. It focuses on individuals who cannot receive or have decided not to receive standard cisplatin chemotherapy. The trial compares different approaches: surgery alone, surgery combined with a drug called pembrolizumab, or surgery combined with two drugs, pembrolizumab and enfortumab vedotin. The main goal is to see if adding these new drug treatments before and/or after surgery can improve how long people live without their cancer coming back, compared to surgery on its own. This aims to find better ways to treat this serious type of bladder cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
595
Start
24 Jul 2019
Estimated completion
15 Dec 2027

What is this study about?

This study, called KEYNOTE-905/EV-303, is focused on improving treatments for muscle-invasive bladder cancer (MIBC). This means the cancer has grown into the bladder's muscle wall, which is a more serious stage. Usually, people with this type of cancer are offered chemotherapy before surgery. However, some people can't have this standard chemotherapy, maybe because of kidney problems, heart issues, hearing loss, or general health. Others might simply choose not to have it.

For these individuals, this study is testing whether adding new drug treatments, called pembrolizumab or a combination of pembrolizumab and enfortumab vedotin, before and/or after surgery can lead to better outcomes than surgery alone. Pembrolizumab is an immunotherapy that helps your body’s own immune system fight cancer. Enfortumab vedotin is another type of drug that targets cancer cells directly. The main purpose is to see if these new approaches can help people live longer without their cancer returning.

It's important to understand that this is a Phase 3 study, which means these treatments are considered experimental in this setting and are being carefully compared with current standard care for people who are unsuitable for cisplatin. The researchers are looking at how well the treatments work and if they are safe. This research aims to expand treatment options and improve the long-term outlook for people facing muscle-invasive bladder cancer.

Key takeaways

  • New treatments for muscle-invasive bladder cancer are being studied.
  • The study focuses on patients who can't have or choose not to have standard chemotherapy.
  • It compares surgery alone to surgery plus new drugs (pembrolizumab or pembrolizumab + enfortumab vedotin).
  • The main goal is to improve how long patients live without their cancer returning.
  • Participation involves surgery, potential drug treatment, and regular check-ups.
  • This is a Phase 3 trial, meaning the treatments are still being tested for effectiveness and safety.

Who may be eligible?

To be considered for this study, you would need to have muscle-invasive bladder cancer that has not spread to other parts of your body. Your doctors must confirm it's a specific type of bladder cancer, and you must be suitable for major surgery to remove your bladder and nearby lymph nodes.

A key requirement is that you either cannot receive cisplatin chemotherapy — perhaps due to kidney issues, certain heart conditions, significant hearing loss, or a lower energy level (ECOG performance status 2) — or you are eligible for cisplatin but have chosen not to have it. You also need to have generally good organ function and undergo a small procedure to remove some bladder tissue for testing.

Both men and women can participate, and there are specific requirements concerning contraception for men taking certain study drugs and for women who could become pregnant. All participants must be at least 18 years old.

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.

  1. Do I have muscle-invasive bladder cancer that hasn't spread?
  2. Am I able and willing to have surgery to remove my bladder and nearby lymph nodes?
  3. Can I not receive standard cisplatin chemotherapy, or have I decided not to?
  4. Am I at least 18 years old?
  5. Do I have generally good organ function?
Answer every question to see your result.

What does participation involve?

If you join this study, it would involve a series of doctor's visits, medical checks, and possibly receiving study medication before and/or after your surgery. The type of surgery you would have is a standard operation to remove the bladder and surrounding lymph nodes. You would have regular check-ups, including scans and blood tests, to monitor your health and the cancer. The total duration of your participation would involve the treatment period and then a follow-up period to track your progress over time. More detailed information would be provided by the study team.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new and experimental treatments that might be more effective than current options, especially if standard treatments aren't suitable for you. However, there are also potential risks, as the new drugs might have side effects that are not fully known or could be more severe than existing treatments. There's no guarantee that the new treatments will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (242)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of South Alabama, Mitchell Cancer Institute ( Site 1582)
    Verified postcode
    Mobile, United States
  • CARTI Cancer Center ( Site 1577)
    Verified postcode
    Little Rock, United States
  • St. Joseph Heritage Healthcare ( Site 0046)
    Verified postcode
    Fullerton, United States
  • Scripps MD Anderson ( Site 0010)
    Verified postcode
    La Jolla, United States
  • Hoag Memorial Hospital Presbyterian ( Site 1595)
    Verified postcode
    Newport Beach, United States
  • John Wayne Cancer Institute ( Site 0075)
    Verified postcode
    Santa Monica, United States
  • University of Colorado Hospital ( Site 0098)
    Verified postcode
    Aurora, United States
  • Georgetown University Medical Center ( Site 0022)
    Verified postcode
    Washington D.C., United States
  • Emory School of Medicine ( Site 0006)
    Verified postcode
    Atlanta, United States
  • John H. Stroger Jr. Hospital of Cook County ( Site 1551)
    Verified postcode
    Chicago, United States
  • University of Chicago ( Site 0068)
    Verified postcode
    Chicago, United States
  • Parkview Cancer Institute ( Site 0077)
    Verified postcode
    Fort Wayne, United States

Common questions

What is muscle-invasive bladder cancer?

This is a type of bladder cancer that has grown into the muscle wall of the bladder, making it a more serious condition.

Why is this study looking at people who can't have cisplatin?

Cisplatin is a standard chemotherapy, but some people can't take it due to other health problems or choose not to. This study aims to find new options for them.

What are pembrolizumab and enfortumab vedotin?

These are new types of cancer drugs. Pembrolizumab boosts your immune system to fight cancer, while enfortumab vedotin targets cancer cells directly.

Will I definitely get the new drugs in this study?

This study compares different approaches, including surgery alone, surgery with one drug, or surgery with two drugs. You might be assigned to any of these groups.

What kind of surgery is involved?

The surgery is a radical cystectomy, which means removing the bladder and nearby lymph nodes. This is a common treatment for this type of cancer.

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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