RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

This research is looking at a new drug called Sacituzumab Tirumotecan for people with a specific type of bladder cancer. This cancer is called Non-Muscle Invasive Bladder Cancer, meaning it's in the bladder's lining but hasn't spread deeper into the muscle. The main aims are to find out if the drug is safe, if people can tolerate it when it's put directly into the bladder, and to discover the highest dose that can be given without causing too many problems. Once a safe dose is found, it will be used in future studies to see how effective the medicine is at treating the cancer. Participants will receive the study medicine, and will also receive standard care and help for any side effects.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

20 Dec 2024

Estimated completion

31 Jul 2028

Non-Muscle Invasive Bladder Cancer

What is this study about?

This study, called MK-2870-027, is investigating a new treatment named Sacituzumab Tirumotecan for a common type of bladder cancer. This specific type is called 'Non-Muscle Invasive Bladder Cancer' (NMIBC). Non-muscle invasive means the cancer has only grown into the inner lining of your bladder and hasn't yet spread into the deeper muscle layers. This is important because it often means the cancer can be treated with less aggressive methods.

The main aim of this study is to understand more about Sacituzumab Tirumotecan. In this first stage, the researchers are focused on safety. They want to find the best dose that people can take without experiencing too many side effects when the medicine is given directly into the bladder. They also want to see if people can comfortably tolerate this treatment. Once they pinpoint the safest and most tolerable dose, this information will help them design future studies to see how well the drug works at treating the cancer itself.

Taking part in a study like this helps advance our understanding of new treatments. Even though it's an early-stage trial, the information gathered is vital. It could potentially lead to new options for people living with bladder cancer in the future. The trial is carefully designed to put your safety first, and you'll be closely monitored throughout.

Key takeaways

This study is testing a new bladder cancer medicine given directly into the bladder.
It's for a specific type of bladder cancer that has not spread into the muscle.
The main goal is to find a safe dose and see how well people tolerate the medicine.
Participants will receive the new medicine and standard supportive care.
The study is in its early stages, aiming to gather important safety information.
Your safety and well-being will be closely monitored throughout.

Who may be eligible?

To be considered for this study, you would need to have a type of bladder cancer called Non-Muscle Invasive Bladder Cancer (NMIBC) that keeps coming back, even after previous treatments. This cancer must be 'low-grade' and visible in your bladder when doctors look with a special camera. You also need to be generally well enough to participate in the study activities.

There are certain reasons why you might not be able to join. For example, if you have newly diagnosed bladder cancer, or if your cancer has ever been a more aggressive type (high-grade) or has spread into the deeper muscle of your bladder. Conditions like severe dry eye, certain inflammatory bowel diseases, or uncontrolled heart problems would also prevent participation.

The study team will carefully review your medical history and test results to see if this study is suitable and safe for you. They will explain everything clearly.

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 only affects the lining (Non-Muscle Invasive)?
Has my bladder cancer returned even after previous treatments?
Am I generally well and able to hold urine for 1-2 hours?
Have I had other serious health problems like severe dry eye, certain bowel conditions, or uncontrolled heart disease?
Has my bladder cancer ever been a more aggressive type (high-grade) or spread into the bladder muscle?
Am I at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational medicine, Sacituzumab Tirumotecan, which will be given directly into your bladder. You would also continue to receive your usual supportive care, which means you'll still get standard medical care for your bladder cancer and any side effects you might experience.

Throughout the study, you'll have regular hospital visits, where doctors and nurses will monitor your health, check for any side effects, and perform tests like cystoscopies (looking inside your bladder with a camera) to see how you're responding. The total duration of your participation will depend on the study's plan and your individual response, but this will be fully explained before you agree to join.

Potential risks and benefits

Taking part in an early-stage study like this means you might be among the first to receive this new medicine. While there's no guarantee it will directly benefit your cancer, you would be helping researchers learn more about a potential new treatment. You will be closely monitored, and any side effects will be managed with 'rescue medication' and supportive care. However, like all medicines, Sacituzumab Tirumotecan could have side effects, some of which might be unknown. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (13)

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

Michael G Oefelein Clinical Trials ( Site 0053)
Verified postcode
Bakersfield, United States· Recruiting
Moffitt Cancer Center ( Site 0057)
Verified postcode
Tampa, United States· Recruiting
Northwestern University ( Site 0051)
Verified postcode
Chicago, United States· Recruiting
Johns Hopkins University ( Site 0055)
Verified postcode
Baltimore, United States· Recruiting
Princess Margaret Cancer Centre ( Site 0003)
Verified postcode
Toronto, Canada· Recruiting
CIUSSS de l'Estrie-CHUS ( Site 0002)
Verified postcode
Sherbrooke, Canada· Recruiting
Hôpital Claude Huriez ( Site 0012)
Verified postcode
Lille, France· Recruiting
HENRI MONDOR HOSPITAL ( Site 0011)
Verified postcode
Créteil, France· Recruiting
Gustave Roussy ( Site 0013)
Verified postcode
Villejuif, France· Recruiting
Erasmus Medisch Centrum ( Site 0032)
Verified postcode
Rotterdam, Netherlands· Recruiting
Hospital Universitario Virgen de la Victoria ( Site 0043)
Verified postcode
Málaga, Spain· Recruiting
Hospital Universitario 12 de Octubre ( Site 0042)
Verified postcode
Madrid, Spain· Recruiting

Common questions

What is Non-Muscle Invasive Bladder Cancer?

It's a type of bladder cancer that has only grown into the inner lining of your bladder and hasn't spread into the deeper muscle layer.

What is Sacituzumab Tirumotecan?

It's a new medicine being tested in this study for bladder cancer. It's given directly into the bladder.

What does 'Phase 1/2' mean?

It means the study is in its early stages. Phase 1 focuses on finding a safe dose, and Phase 2 starts to look at how well the treatment works.

Will I get 'rescue medication'?

Yes, if you experience side effects or discomfort, you will receive appropriate medication and care to help manage them.

How long will I be in the study?

The exact length will be discussed with you by the study team, but you'll be monitored regularly throughout your participation.

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.