Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

This research study is looking at a new potential cancer medicine called MK-1088. We are testing its safety and how well people can tolerate it, both when given on its own and when given with another common cancer drug called Pembrolizumab (Keytruda). The study is for adults with advanced solid tumours, which means cancers that have spread. This is a "Phase 1/Phase 2" study, meaning it's an early stage of testing new treatments. The main goal is to understand any side effects and how many people experience them, rather than how effective the treatment is at this stage. It helps us learn if the medicine is safe enough to explore further.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

28 Feb 2023

Treatment of advanced/metastatic solid tumors

What is this study about?

This study is about a new medicine called MK-1088, which is being investigated as a potential treatment for advanced solid tumours. "Solid tumours" are basically lumps or masses of cancer cells found in organs like the lung, breast, or bowel, as opposed to blood cancers. "Advanced" means the cancer has grown or spread.

The study will look at MK-1088 on its own and also in combination with an existing cancer medicine called Pembrolizumab, which you might know as Keytruda. Keytruda is a type of immunotherapy that helps your body's immune system fight cancer. By combining them, researchers hope to see if they might work better together.

This is an early-stage study, known as Phase 1/Phase 2. This means the main focus isn't on how well the drug treats cancer, but much more on its safety. The researchers want to find out what side effects might happen, how common they are, and if people can tolerate the treatment. This crucial step helps them understand if it's safe enough to continue testing in larger studies to see how effective it is.

Key takeaways

This study tests a new cancer drug (MK-1088) for advanced solid tumours.
It's an early-stage study (Phase 1/2) focused on safety and side effects.
The new drug may be given alone or with an existing treatment (Keytruda).
Participation involves regular clinic visits for treatment and health checks.
You can withdraw from the study at any time without penalty.
Potential benefits include access to new treatments, but risks of side effects exist.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or over. There's no upper age limit, so people of all adult ages can potentially join.

It's important that you have an advanced solid tumour. This means your cancer is no longer confined to its original site and may have spread to other parts of your body. The study includes both men and women.

Beyond these basic conditions, there will be other medical checks and criteria that a study doctor will discuss with you. These are to make sure the study treatment is as safe as possible 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?
Have you been diagnosed with an advanced solid tumour (cancer that has spread)?
Are you able to attend regular clinic appointments for treatment and check-ups?
Are you considering a new treatment option for your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine MK-1088 on its own, or MK-1088 combined with Keytruda, given as a drip (infusion). You'll have regular visits to the clinic for these treatments and to be checked over.

During these visits, the study team will keep a close eye on you. They will ask you about any symptoms you're experiencing, carry out physical examinations, and take blood tests. This is to monitor your health, check for any changes, and understand how the treatment is affecting you.

The main things the researchers will be looking for are any side effects, how well you tolerate the treatment, and if you need to stop treatment for any reason. They will also take blood samples to measure how much of the medicine is in your body over time. The total duration of your participation, including follow-up after treatment, will be explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new medicine that isn't widely available yet, which could potentially help you. However, there's no guarantee the treatment will improve your condition, as this study is mainly focused on safety. There are always potential risks involved, as with any medicine. Side effects, some of which could be serious, might occur. The study team will monitor you closely and explain all known and potential risks. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, which would not affect your future medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What kind of cancer is this study for?

This study is for people who have advanced solid tumours, which means cancers that have spread from where they started.

What does 'Phase 1/Phase 2' mean?

It means this is an early study primarily focused on understanding if a new medicine is safe and how well people can tolerate it, rather than just how effective it is.

Will I get a new medicine or an existing one?

You will receive the new medicine MK-1088, either by itself or along with a known cancer medicine called Pembrolizumab (Keytruda).

What are 'side effects' and 'adverse events'?

These are simply fancy terms for any unwanted or unexpected reactions or health problems that might happen during the study, which could be related to the treatment or not.

Can I stop participating in the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.