Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)

This research study is trying out a new medicine, called MK-0482, for people who have advanced solid tumours (which is a type of cancer that starts as a lump or growth, like in the breast or lung). Researchers will be giving this new medicine on its own to some participants. Others will receive it alongside an existing cancer medicine called pembrolizumab, which is already used in many cancer treatments. This is a Phase 1 study, meaning it's one of the first times this new medicine is being given to people. The main aims are to understand if it's safe, how much medicine can be given, and what effects it has on the body. We call this 'human pharmacology', which simply means studying how the drug works in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

21 Jul 2023

Advanced Solid Tumors

What is this study about?

This study is focused on a new potential medicine, called MK-0482, which is being investigated for people living with advanced solid tumours. "Advanced solid tumours" means cancers that started as a lump or growth, like bowel, lung, or breast cancer, and have spread within the body. At this stage, the cancer can be more challenging to treat with standard methods.

The main purpose of this study is to learn more about how this new medicine (MK-0482) behaves in the human body. Researchers want to understand if it's safe to use, what are the best doses, and how the body processes it. They will be looking at MK-0482 by itself (as a 'monotherapy') and also in combination with another widely used cancer treatment called pembrolizumab. Pembrolizumab (also known as Keytruda) is a type of immunotherapy that helps your own immune system fight cancer. Combining new and existing medicines is a common approach in cancer research to see if they can work better together.

This is a "Phase 1" study, which means it's one of the very first times this new medicine is being given to people. At this early stage, studies involve a smaller number of participants, and the primary focus is always on safety and understanding how the drug works in the body, rather than how effective it is at treating the cancer itself. The information gathered from this study will be crucial for deciding if this new medicine should be tested further in larger studies.

Key takeaways

This study is testing a new medicine (MK-0482) for advanced solid tumours.
It's a Phase 1 study, meaning the focus is on safety and how the drug works in the body.
The new medicine will be given alone or with an existing cancer drug (pembrolizumab).
Both men and women, aged 18 and over, with advanced solid tumours are eligible.
Participation involves regular hospital visits, tests, and closely monitored doses of medication.
You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old – there is no upper age limit. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with advanced solid tumours. This means your cancer started as a solid growth in an organ, such as the lung, bowel, or breast, and has spread.

Because this is a very early-stage study, there will be strict medical requirements to ensure participant safety. For instance, doctors will need to check your overall health, including how well your liver and kidneys are working, and that you don't have certain other health conditions that could make the treatment unsafe for you. You would also need to have tried and not responded well to standard cancer treatments, or have a cancer for which there are no effective standard treatments available.

The research team will carry out a thorough check of your medical history, recent treatments, and current health to determine if this study is suitable and safe for you to join. It's really important that you discuss all your medical conditions and medicines with them.

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?
Have you been diagnosed with an advanced solid tumour (cancer that started as a lump and has spread)?
Are you able to attend regular hospital visits for tests and treatment?
Are you willing to follow specific study instructions and take the study medicine as directed?
Have you discussed this study with your current doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve various tests to check your health, such as blood tests, urine tests, and physical examinations. You will also have regular scans (like CT scans or MRI scans) to monitor your cancer and see how your body is responding to the treatment. The new medicine, MK-0482, will be given to you as part of the study, either on its own or with pembrolizumab, depending on which group you are in. The study team will explain exactly how and when you will receive the medication.

The frequency of visits might be more intensive at the beginning of the study to closely monitor your reaction to the new medicine. Over time, if you tolerate the treatment well, the visits might become less frequent. After you stop receiving the study medicine, you will have a follow-up period where the researchers will continue to check on your health and any long-term effects. The total length of your participation will vary but can range from several months to potentially longer, including the follow-up period. All appointments and procedures related to the study will be explained in detail.

Potential risks and benefits

Taking part in a clinical trial like this can have potential benefits. You might get access to a new medicine that isn't yet available to everyone, which could potentially help with your advanced cancer. However, it's also important to remember that this is a new medicine, and its effects are not fully known. There are potential risks, including side effects from the study medicine itself or from the combination of medicines. These side effects could be mild, like feeling tired, or more serious. The research team will monitor you very closely for any side effects and will explain all known risks. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Italy

Common questions

What does 'advanced solid tumours' mean?

This means a type of cancer that started as a lump or growth in an organ, like the lung or bowel, and has spread to other parts of the body.

What is a 'Phase 1' study?

It's the very first stage of testing a new medicine in people. The main goals are to check if it's safe, find the right dose, and see how it works in the body.

What is MK-0482?

MK-0482 is the code name for a new experimental medicine being investigated for advanced cancer. Its full details are being kept confidential for now.

What is pembrolizumab?

Pembrolizumab (also known as Keytruda) is an existing cancer medicine that boosts your body's own immune system to fight cancer cells. It's used in many cancer treatments already.

Can taking part help me?

You might get access to a new medicine that isn't widely available yet, which could potentially help your cancer. However, there's no guarantee, and the main goal of this early study is to learn about safety.