RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)

This research study is investigating a new medication, MK-3120, for people with advanced solid tumors. Advanced solid tumors are cancers that started in body organs or tissues and have spread to other parts of the body, making them difficult to remove with surgery. The main aim of this study is to understand how safe MK-3120 is and how well people tolerate it. This is a common first step for new medicines. By learning about its safety and side effects, doctors can decide if it's suitable for further testing. The study is open to adults aged 18 and over who have this type of cancer and have already tried other available treatments.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

270

Start

25 Mar 2025

Estimated completion

25 Mar 2031

Advanced Solid Tumors Malignant Neoplasm

What is this study about?

Doctors are always looking for better ways to treat cancer, especially when it has spread. This study is focusing on a new medicine called MK-3120 for people who have advanced solid tumors. A 'solid tumor' is a growth of cells, like those found in organs such as the lung or breast, rather than cancers of the blood. 'Advanced' means the cancer has spread to other parts of your body and can't be fully removed by an operation.

The main purpose of this study is to find out if MK-3120 is safe to use and what side effects it might cause. When a new medicine is first tested, it's really important to understand how the body reacts to it and if people can take it without too many problems. This stage helps doctors work out the right dose to use in the future.

Taking part in this study would help researchers gather important information about MK-3120. This could potentially lead to new treatment options for people with advanced solid tumors in the future. It's a vital step in developing new medicines.

Key takeaways

This study is testing a new medicine called MK-3120 for advanced solid tumors.
The main goals are to check the medicine's safety and how well people tolerate it.
It's for adults aged 18 and over who have already tried other treatments.
Participation involves regular check-ups and tests.
There might be some benefits, but also potential side effects, as it's a new drug.

Who may be eligible?

To join this study, you must be 18 years or older and have certain types of advanced solid tumors that cannot be removed by surgery and have spread. You should have already tried other available treatments, or these treatments weren't suitable for you. If you have HIV, Hepatitis B, or Hepatitis C, these conditions need to be well managed and under control with treatment for you to be considered.

However, there are reasons why you might not be able to join. For example, if you have certain active heart or brain conditions, or serious eye conditions. Also, if you have active infections or certain lung problems, you wouldn't be able to take part.

Doctors will also check if you have certain other serious conditions, such as some types of bowel disease, or certain fluid build-ups around your lungs, heart, or in your tummy, that are causing symptoms or need regular draining. They will also consider if you have had any other cancers that have needed treatment recently or if your cancer has spread to your brain or spinal cord and is causing problems.

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.

Are you 18 years old or older?
Do you have an advanced solid tumor that has spread and can't be removed with surgery?
Have you already tried other cancer treatments, or are they not suitable for you?
Are any other medical conditions you have (like HIV or Hepatitis) well-controlled by treatment?
Do you *not* have certain serious heart, eye, or lung conditions that are active?
Do you *not* have active infections that need strong medicines?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the study medicine, MK-3120. You will have regular appointments with the study doctors and nurses. These visits will involve various tests, such as blood tests, scans, and physical examinations, to check how you are responding to the medication and to monitor your health and any side effects. You will also be asked questions about how you are feeling. The study team will explain exactly what your schedule of visits and tests will be. The total length of your participation will depend on how you respond to the treatment and what the study doctors advise regarding your safety and well-being.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new treatment that isn't widely available yet. While there's no guarantee the treatment will help, the information gathered could benefit other patients in the future. However, new medicines can have side effects, and these are still being learned about. The study team will carefully monitor you for any side effects and will explain all known risks. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (45)

The University of Alabama at Birmingham ( Site 1005)
Verified postcode
Birmingham, United States· Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)
Verified postcode
Miami, United States· Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)
Verified postcode
Hackensack, United States· Recruiting
NEXT Oncology ( Site 1010)
Verified postcode
Austin, United States· Recruiting
NEXT Oncology ( Site 1011)
Verified postcode
Houston, United States· Recruiting
NEXT Oncology ( Site 1012)
Verified postcode
Irving, United States· Recruiting
Virginia Commonwealth University ( Site 1008)
Verified postcode
Richmond, United States· Recruiting
Centro de Estudios Clínicos SAGA ( Site 0033)
Verified postcode
Santiago, Chile· Recruiting
FALP ( Site 0031)
Verified postcode
Santiago, Chile· Recruiting
Pontificia Universidad Catolica de Chile ( Site 0032)
Verified postcode
Santiago, Chile· Recruiting
Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)
Verified postcode
Santiago, Chile· Recruiting
Peking University First Hospital ( Site 0180)
Verified postcode
Beijing, China· Recruiting

Common questions

What is an 'advanced solid tumor'?

It's a type of cancer that started in an organ or tissue (not blood) and has spread to other parts of your body. Surgeons can't usually remove it all.

What is MK-3120?

It's a new medicine being tested. Researchers want to see if it's safe to use and what effects it has on people with advanced solid tumors.

What does 'Phase 1/2' mean?

This refers to the early stages of testing a new medicine. Phase 1 mainly checks for safety, while Phase 2 looks at how well the medicine works and also continues to monitor safety.

Will I get paid to join the study?

Clinical trials usually don't pay participants for taking part. However, some studies might cover travel costs or other expenses related to your visits.

Can I stop taking part in the study if I want to?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your standard medical care in any way.

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.