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Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)

This research study is investigating new treatment options for people with advanced bladder cancer, specifically locally advanced or metastatic urothelial carcinoma. Doctors are testing a combination of two medicines, sacituzumab tirumotecan and enfortumab vedotin, to understand their safety and how well they work. This study is split into two parts. The first part focuses on checking the safety and early effectiveness of this drug combination. This type of research is crucial for developing better and more effective ways to manage advanced bladder cancer, offering hope for improved outcomes for patients in the future. The overall goal is to find treatments that can slow down the cancer's spread and improve quality of life.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
38
Start
17 Jul 2024
Estimated completion
31 Mar 2028

What is this study about?

This study is all about finding better ways to treat a type of bladder cancer called urothelial carcinoma, when it has spread or is very advanced. This can be a challenging condition, and doctors are always working to discover new treatments that are both safe and effective.

The main idea behind this study is to look at a new drug, sacituzumab tirumotecan, when it's given alongside a treatment already used for this cancer, called enfortumab vedotin. Think of it like trying out a new recipe combination to see if it tastes even better or works more effectively. The researchers want to understand if this new combination can help slow down the cancer or even shrink it, while also making sure it's safe for patients to use.

This study is conducted in phases, starting with a focus on safety and early signs of effectiveness. It’s part of a larger ongoing research effort to develop new and improved therapies for advanced bladder cancer. Finding new treatments means more options for patients and the potential for better results in the future.

Key takeaways

  • Tests a new combination of drugs for advanced bladder cancer.
  • Focuses on safety and how well the treatment works.
  • Specifically for advanced urothelial carcinoma.
  • Participants must have had prior platinum-based chemotherapy.
  • Aims to find better treatment options for patients.

Who may be eligible?

To be part of this study, you would generally need to have bladder cancer that has spread (metastatic) or is locally advanced. Doctors would also need a recent tissue sample from your cancer to help them understand more about it.

For the first part of this study, you must have already had chemotherapy treatment that included platinum-based drugs for your advanced bladder cancer. Also, you should not have had more than two types of treatment for your advanced cancer before joining. If you had platinum-based chemotherapy followed by a maintenance drug called avelumab, that counts as two treatments.

There are also some reasons why you might not be able to join. For example, if you have other active cancers, certain severe heart problems, nerve damage (peripheral neuropathy) above a certain level, or specific eye conditions that could be affected by the study drugs.

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 locally advanced or metastatic urothelial carcinoma (a type of bladder cancer)?
  2. Have I already received platinum-based chemotherapy for my advanced bladder cancer?
  3. Have I had two or fewer lines of therapy (types of treatment) for my advanced bladder cancer?
  4. Do I have any other active cancers, severe heart problems, or nerve damage greater than Grade 2?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the experimental treatments. You'll have regular visits to the clinic for assessments, which will likely include physical exams, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. The specific schedule and duration of treatment and follow-up will depend on the study's protocol and your individual response. The total time you spend in the study will vary, but usually involves treatment cycles and then a period of follow-up care to track your progress and long-term health. You'll be closely monitored by the study team throughout.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which could improve your condition. However, there are also potential risks, as new treatments can have side effects that are not yet fully known. You might not get the treatment that works best for you, and there's no guarantee the treatment will help. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California San Francisco HDFCCC ( Site 4044)
    Verified postcode
    San Francisco, United States
  • University of Chicago Medical Center ( Site 4037)
    Verified postcode
    Chicago, United States
  • Indiana University Melvin and Bren Simon Cancer Center ( Site 4011)
    Verified postcode
    Indianapolis, United States
  • Dana-Farber Cancer Institute ( Site 4047)
    Verified postcode
    Boston, United States
  • Siteman Cancer Center ( Site 4038)
    Verified postcode
    St Louis, United States
  • Icahn School of Medicine at Mount Sinai ( Site 4018)
    Verified postcode
    New York, United States
  • Cleveland Clinic-Taussig Cancer Center ( Site 4036)
    Verified postcode
    Cleveland, United States
  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 4041)
    Verified postcode
    Salt Lake City, United States
  • The Ottawa Hospital - General Campus ( Site 4105)
    Verified postcode
    Ottawa, Canada
  • Princess Margaret Cancer Centre ( Site 4106)
    Verified postcode
    Toronto, Canada
  • Centre Hospitalier Lyon Sud ( Site 4606)
    Verified postcode
    Pierre-Bénite, France
  • Rambam Health Care Campus ( Site 4501)
    Verified postcode
    Haifa, Israel

Common questions

What type of cancer is this study for?

This study is for advanced bladder cancer, specifically called locally advanced or metastatic urothelial carcinoma.

What treatments are being tested?

Doctors are testing a combination of two medicines: sacituzumab tirumotecan and enfortumab vedotin.

What is the main goal of this study?

The main goal is to find out how safe these new treatment combinations are and how well they work to treat advanced bladder cancer.

Can I join this study if I haven't had any previous treatment for my advanced bladder cancer?

No, for the part of the study currently running, you must have already had platinum-based chemotherapy for your advanced bladder cancer.

Will I have to travel a lot for this study?

Participation will involve regular clinic visits for treatments, tests, and check-ups. The frequency and location of these visits will be discussed with you by the study team.

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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