Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

This study, called MK-2870-015, is investigating a new medicine named sacituzumab tirumotecan for people with advanced stomach or oesophagus cancer that has spread. The main aim is to see if this new medicine is more effective and safer than the usual treatments chosen by doctors. Participants in the study will either receive sacituzumab tirumotecan or one of the standard treatments like trifluridine-tipiracil, irinotecan, paclitaxel, or docetaxel. The study particularly wants to find out if sacituzumab tirumotecan helps people live longer. It's a Phase 3 study, which means it's a later stage of research, usually involving a larger group of people to confirm the medicine's benefits and safety.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

450

Start

03 May 2024

Estimated completion

06 May 2027

Gastroesophageal Cancer

What is this study about?

This study is looking into a new treatment for a type of cancer that affects the stomach or the tube connecting your throat to your stomach (oesophagus). This cancer is described as 'advanced' or 'metastatic,' which means it has spread to other parts of the body and can't be removed with surgery alone. The new medicine being tested is called sacituzumab tirumotecan.

The main goal of the study is to compare sacituzumab tirumotecan with treatments already chosen by doctors, such as trifluridine-tipiracil, irinotecan, paclitaxel, or docetaxel. Researchers want to see if sacituzumab tirumotecan is more effective at treating the cancer and if it causes fewer side effects or different ones, compared to existing treatments. They are especially interested in whether this new medicine helps people live longer.

Taking part in a study like this helps us learn more about new treatments. If sacituzumab tirumotecan proves to be better than current options, it could become a new way to help people with this type of cancer in the future. It's a 'Phase 3' study, meaning it's a large, important step in clinical research, usually done after earlier studies have shown promising results.

Key takeaways

The study explores a new medicine for advanced stomach/oesophagus cancer.
It aims to see if the new medicine is safer and more effective than standard treatments.
Participation is for those who've had at least two previous cancer treatments.
Regular health checks and supportive care are provided.
You might receive the new medicine or a standard treatment.
You can stop participating at any time.

Who may be eligible?

To join this study, your doctor would need to confirm that you have advanced stomach or oesophagus cancer that has spread.

You would need to have already tried at least two different chemotherapy or immunotherapy treatments for your cancer, but unfortunately, your cancer has grown or returned. Your doctor would also need to see that your cancer can be measured on scans and that you are generally well enough to take part. This includes having healthy organ function and being able to swallow pills if you are given certain treatments.

There are also some reasons why you might not be able to join, such as having a history of severe dry eye. Your medical team will carefully check all your health details to see if this study is right for you, including checking your cancer cells for a specific marker called TROP2 and making sure any side effects from previous treatments have mostly cleared up.

Quick self-check

I have advanced stomach or oesophagus cancer that has spread.
I have already tried at least two other chemotherapy or immunotherapy treatments.
My cancer can be measured on scans.
My doctors say my organs are generally working well.
I'm able to swallow medication if needed.
Any side effects from my previous treatments have mostly gone away (to Grade 1 or less).

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would undergo regular assessments, which might include blood tests, scans, and physical examinations, to monitor your health and how the treatment is working. You would either receive the new medicine, sacituzumab tirumotecan, or one of the standard treatments chosen by your doctor. These treatments could be given in different ways, such as by injection, infusion into a vein, or as tablets.

You would also receive what are called 'rescue medications' and 'supportive care' to help manage any side effects or discomfort you might experience. The number of visits, the exact tests, and how long you stay in the study would depend on the treatment you receive and how your body responds. However, rest assured, the study team would explain everything in detail, and you would be closely looked after throughout your participation. You can expect regular follow-up during and after your treatment period.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from a new treatment that could be more effective than current options, and you would receive close medical attention. However, there's also a chance the new treatment might not work for you, or you could experience side effects, some of which might be serious. The study team will explain all the known risks and potential benefits before you decide to join. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (168)

Banner MD Anderson Cancer Center ( Site 0119)
Gilbert, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0140)
Los Angeles, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129)
Orlando, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)
Marietta, United States
University of Chicago Medical Center ( Site 0120)
Chicago, United States
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124)
Lexington, United States
The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113)
Louisville, United States
Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105)
Louisville, United States
Henry Ford Hospital ( Site 0107)
Detroit, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138)
Fargo, United States
Oregon Health and Science University ( Site 0104)
Portland, United States
UPMC Hillman Cancer Center ( Site 0126)
Pittsburgh, United States

+156 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study for?

This study is for advanced stomach or oesophagus cancer that has spread to other parts of the body.

What is sacituzumab tirumotecan?

It's a new medicine being tested to see if it's better than current treatments for this type of cancer.

Do I have to pay to be in the study?

No, all study-related treatments and tests are provided at no cost to you.

What happens if I want to leave the study?

You can leave the study at any time, for any reason, and it won't affect your ongoing medical care.

Will I definitely get the new medicine?

You might get the new medicine or one of the standard treatments. It's decided randomly, like flipping a coin.