RecruitingPHASE1INTERVENTIONAL

A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

This research study is investigating a new medication called MK-4716 for people with certain advanced solid tumours. The main aim is to understand how safe MK-4716 is and how well people can tolerate it. It will be given either on its own or together with other existing cancer treatments like Pembrolizumab or Cetuximab. Researchers hope to find new and more effective ways to treat these types of cancer, especially in cases where previous treatments haven't worked or the cancer has spread. This is an early stage (Phase 1) study, focusing on safety rather than whether the treatment cures the cancer. If successful, it could lead to further research and potentially new treatment options in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

250

Start

16 Dec 2025

Estimated completion

01 Dec 2030

Malignant Neoplasm

What is this study about?

Imagine your body as having tiny building blocks called cells. Sometimes, these cells can grow out of control and form what we call cancer. When cancer has spread to other parts of the body or is too advanced for surgery, it's called 'advanced' or 'metastatic'.

Doctors and scientists are always looking for new and better ways to fight these advanced cancers. This particular study is about a new medicine called MK-4716. We want to understand if it's safe to use in people, either by itself or when given along with other medicines like Pembrolizumab or Cetuximab. Think of it like testing a new car model: first, you want to make sure it's safe to drive and that people can handle it comfortably.

The team conducting this study hopes that MK-4716, alone or in combination, might offer a new way to treat these cancers. By carefully watching how people react to the medicine, we can learn a lot. This knowledge helps us decide if MK-4716 should be studied further in larger groups of people, and eventually, if it could become a new treatment option available to more patients.

Key takeaways

This study is testing a new cancer medicine, MK-4716, for safety and how well people tolerate it.
It's for adults with certain advanced or widespread solid cancers.
MK-4716 will be given alone or with existing cancer treatments.
Taking part helps advance cancer research, but doesn't guarantee personal benefit.
Regular hospital visits, tests, and scans will be part of the study.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 and over who have certain types of advanced or widespread solid cancers. You might be considered if your cancer has a specific change called a KRAS alteration, and you've already had at least one other treatment for your cancer that hasn't worked, or if your cancer has spread.

However, there are also reasons why people might not be able to join. For instance, if you have certain conditions that affect your immune system, or if you've recently had specific types of treatment, or if your cancer has spread to your brain. Also, if you have other serious health problems like certain infections or specific lung conditions, this study might not be suitable for you.

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 or widespread solid cancer?
Has your cancer been tested for a specific change called a KRAS alteration?
Have you already had at least one other treatment for your cancer that hasn't fully worked, or do you have untreated non-small cell lung cancer with a KRAS alteration?
Can you swallow medication by mouth?
Do you have any serious immune system problems or certain infections like Hepatitis B or C?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be given the study medicine, MK-4716, which you'll take by mouth. You might take it alone, or with Pembrolizumab (given through a drip) or Cetuximab (given through a drip or injection). You'll have regular hospital visits to check how you're feeling, take blood and urine samples, and have scans to see how the treatment is affecting your cancer. These visits will also ensure the treatment is safe for you. The exact number of visits, tests, and total time in the study will depend on which treatment group you are in and how you respond to the medicine. Your study doctor and nurse will explain everything in much more detail.

Potential risks and benefits

While we hope this study will help us find better treatments, there's no guarantee that MK-4716 will cure your cancer or make you feel better. However, by taking part, you'll be contributing to important medical research that could help future patients. Like all medicines, MK-4716 and the other treatments might cause side effects, which could be mild or more serious. We will tell you about all the known and possible side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

Rutgers Cancer Institute of New Jersey ( Site 0052)
Verified postcode
New Brunswick, United States· Recruiting
NEXT Oncology ( Site 0051)
Verified postcode
Irving, United States· Recruiting
NEXT Virginia ( Site 0054)
Verified postcode
Fairfax, United States· Recruiting
Blacktown Hospital ( Site 0455)
Verified postcode
Sydney, Australia· Recruiting
Monash Health ( Site 0452)
Verified postcode
Clayton, Australia· Recruiting
The Alfred Hospital ( Site 0453)
Verified postcode
Melbourne, Australia· Recruiting
One Clinical Research ( Site 0454)
Verified postcode
Nedlands, Australia· Recruiting
Princess Margaret Cancer Centre ( Site 0001)
Verified postcode
Toronto, Canada· Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)
Verified postcode
Québec, Canada· Recruiting
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Verified postcode
Santiago, Chile· Recruiting
Bradfordhill ( Site 0102)
Verified postcode
Santiago, Chile· Recruiting
Rambam Health Care Campus ( Site 0252)
Verified postcode
Haifa, Israel· Recruiting

Common questions

What is a 'solid tumour'?

A solid tumour is a lump or mass of tissue formed by an abnormal growth of cells, unlike 'liquid cancers' like leukaemia which affect the blood.

What does 'Phase 1' mean for a study?

Phase 1 is the first stage of testing a new medicine in people. Its main goal is to check if the medicine is safe and find the right dose, rather than seeing if it cures the disease.

What is a 'KRAS alteration'?

KRAS is a gene in your cells. An 'alteration' means there's a change in this gene, which can sometimes make cancer cells grow. This study is looking at cancers with this specific change.

Will I know if I'm getting the new medicine?

Yes, in this type of study, you will always be receiving the study medication, MK-4716, either alone or with other treatments. It's not a 'placebo' (dummy treatment) study.

How long will I be in the study?

The length of time you'll be in the study will depend on how you respond to the treatment and the specific group you're in. Your doctor will explain this during your visit.

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.