RecruitingPHASE3INTERVENTIONAL

A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

This study is investigating a new treatment called Sacituzumab Tirumotecan (Sac-TMT) for a type of bladder cancer that has spread or is advanced and hasn't responded well to previous treatments. We're looking to see if Sac-TMT can help people with this condition live longer than those receiving standard chemotherapy options like Vinflunine, Docetaxel, or Paclitaxel. This is a Phase 3 trial, which means it involves a larger group of people to confirm if the new medicine is effective and safe. The study aims to find new ways to help patients whose cancer has progressed after standard treatments, including immunotherapy and platinum-based chemotherapy.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

590

Start

23 Apr 2026

Estimated completion

23 Apr 2030

Bladder Cancer

What is this study about?

This clinical trial is looking for a new treatment for a type of cancer that affects the bladder, called urothelial cancer. This is specifically for cases where the cancer has spread to other parts of the body (metastatic) or is advanced locally and can't be removed by surgery or treated with radiation. Currently, doctors use treatments like chemotherapy, immunotherapy, and targeted therapies for this kind of cancer. However, researchers are always trying to find even better options, especially for people whose cancer has unfortunately started to get worse after these standard treatments.

The new medicine being tested in this study is called Sacituzumab Tirumotecan, or Sac-TMT for short. The main goal of this study is to find out if Sac-TMT can help people live longer compared to existing chemotherapy treatments. Participants in this study will either receive Sac-TMT or one of the standard chemotherapy options, such as Vinflunine, Docetaxel, or Paclitaxel.

By comparing Sac-TMT with these established treatments, the researchers hope to understand if it offers a new and more effective way to manage advanced bladder cancer. This kind of research is very important for improving the care of patients in the future.

Key takeaways

This study is for advanced bladder cancer that has worsened after other treatments.
It tests a new medicine called Sacituzumab Tirumotecan (Sac-TMT).
Compares Sac-TMT to standard chemotherapy treatments.
Aims to see if Sac-TMT helps people live longer.
You would receive regular medical check-ups and monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have specific types of advanced urothelial (bladder) cancer that can be measured by doctors. Your cancer must also have started to get worse after you've already had certain treatments, including immunotherapy, platinum-based chemotherapy, and a medicine called enfortumab vedotin. Most people can only have had up to two previous lines of treatment for their cancer.

Your general health also needs to be good enough to take part. This includes having a good 'performance status' (meaning you're able to carry out most daily activities without too much trouble) and your organs functioning well. The research team will check all these details carefully to make sure the study is a safe and suitable option for you.

There are also some reasons why you might not be able to join. For example, if you have certain severe eye conditions or other significant uncontrolled health problems, you might not be eligible. The hospital team will discuss all these points with you to determine if this study is the right fit.

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 advanced bladder cancer that has spread or is locally advanced?
Has my cancer started to get worse after prior treatments (including immunotherapy, platinum chemotherapy, and enfortumab vedotin)?
Have I had no more than two previous lines of cancer treatment?
Am I generally in good health and able to carry out daily activities?
Are my organs (like kidneys and liver) working well?
Do I have any severe eye conditions, as this might prevent me from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, Sacituzumab Tirumotecan, or one of the standard chemotherapy treatments. You would have regular visits to the hospital for your treatment sessions and to have tests like blood tests and scans. These tests help the doctors monitor your health and how your cancer is responding to the treatment. There will also be rescue medications available if you need them for any side effects from your treatment.

Throughout the study, the medical team will closely monitor you. You will also have follow-up appointments after your treatment period to see how you are doing in the longer term. The total duration of your involvement in the study would depend on how your treatment is going and how long you remain on the study drug, followed by a period of observation.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment like Sac-TMT that isn't yet widely available, and which might be more effective for your cancer. You'll also receive very close medical monitoring and care. However, new treatments can also have side effects, and some may be serious. The study treatment might not work for everyone, and it's also possible you could receive a standard treatment rather than the new investigational drug. All potential risks and side effects of both the new medicine and standard treatments will be fully explained to you before you decide. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (82)

Munson Medical Center ( Site 0812)
Verified postcode
Traverse City, United States· Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0832)
Verified postcode
New York, United States· Recruiting
WakeMed Raleigh Campus ( Site 0811)
Verified postcode
Raleigh, United States· Recruiting
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Verified postcode
Cincinnati, United States· Recruiting
The West Clinic, P.C. ( Site 0791)
Verified postcode
Germantown, United States· Recruiting
Thompson Cancer Survival Center ( Site 0803)
Verified postcode
Knoxville, United States· Recruiting
Virginia Oncology Associates (VOA) ( Site 8002)
Verified postcode
Norfolk, United States· Recruiting
Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
Unverified
Ciudad Autonoma de Buenos Aires, Argentina· Recruiting
Instituto Alexander Fleming ( Site 0002)
Unverified
Ciudad Autónoma de Buenos Aires, Argentina· Recruiting
Instituto de Oncologia de Rosario ( Site 0005)
Verified postcode
Rosario, Argentina· Recruiting
Macquarie University ( Site 0031)
Unverified
Macquarie, Australia· Recruiting
Mater Hospital Brisbane ( Site 0032)
Verified postcode
South Brisbane, Australia· Recruiting

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that starts in the cells lining the bladder, ureters, or renal pelvis. It's often called bladder cancer if it starts in the bladder.

What does 'locally advanced or metastatic' mean?

'Locally advanced' means the cancer has grown into nearby tissues but hasn't spread far. 'Metastatic' means the cancer has spread to other parts of the body.

What is a Phase 3 study?

A Phase 3 study is a larger trial that compares a new treatment to existing standard treatments. It aims to confirm if the new treatment is effective and safe for a wider group of people.

Will I definitely get the new medicine?

No, you will be randomly assigned to either receive the new medicine, Sacituzumab Tirumotecan, or one of the standard chemotherapy treatments. It's like flipping a coin for which treatment you get.

What if the treatment isn't working for me?

Your medical team will closely monitor your health and how your cancer responds. If the treatment isn't working or if you experience severe side effects, they will discuss alternative options with you.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.