Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)

This research study, called KeyForm-010, is investigating a new combination of medicines, known as MK-4280A and pembrolizumab, for treating certain types of solid tumours. These are cancers that form solid lumps in the body. The main goal of the study is to see if this new combination can help people with cancer by making their tumours smaller or by improving their overall well-being. It is a Phase 2 trial, which means researchers are actively testing the safety and effectiveness of this treatment in a group of people, before potentially moving to larger studies. Participants will receive one of the study medicines, and researchers will carefully monitor how their cancer responds and any side effects they might experience. This study is crucial for understanding if this new treatment could become a helpful option for future cancer care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

31 Oct 2023

Neoplasm malignant

What is this study about?

This study, called KeyForm-010, is looking into a new way to treat certain solid tumours. Solid tumours are cancers that grow as a solid mass in the body, rather than cancers that affect the blood, for example. The researchers are particularly interested in a new combination of medicines: MK-4280A, which contains two specific drugs (favezelimab and pembrolizumab). Pembrolizumab is also known by its brand name, KEYTRUDA.

The main idea behind this research is to see how well this new combination of medicines can help people with these specific cancers. They want to find out if the treatment can shrink the tumours and improve a person's general health and well-being. This is an early-stage study (Phase 2), meaning it's one of the first times this specific combination is being tested in a group of people to see if it's safe and effective.

By taking part, people will help doctors understand if this new treatment could be a good option for others in the future. The results will help guide further research and potentially lead to new cancer treatments. It’s an important step in improving how we treat cancer.

Key takeaways

It's a study for certain types of solid tumours.
Investigating a new combination of medicines: MK-4280A and pembrolizumab (KEYTRUDA).
Aims to see if the treatment shrinks tumours or improves well-being.
It's a Phase 2 study, meaning it's an early test of safety and effectiveness.
Participants will have regular visits for check-ups, blood tests, and scans.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part. This study is open to both men and women.

It's important to remember that this is just a starting point. There will be other specific health requirements and tests you'll need to meet. For example, the study is for people with particular types of solid tumours. The doctors and nurses running the study will check if you meet all these detailed criteria.

They will make sure the study is a good fit for you and that taking part is safe for your health. If you are interested, your doctor can discuss all the detailed requirements with 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 a type of solid tumour that the study is looking for?
Are you comfortable with regular hospital visits and check-ups?
Are you able to travel to the study site for appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given one of the study medicines, which could be the new combination medicine (MK-4280A) or another treatment like Lenvatinib, as part of a research plan. You will receive these medicines through an infusion (a drip) in a hospital setting. The study team will regularly check how you are doing, how your cancer is responding to the treatment, and if you have any side effects.

You will have several appointments at the hospital or clinic. These visits will involve blood tests, scans (like CT or MRI scans) to measure your tumour, and physical examinations. The doctors will also ask you questions about how you are feeling. The exact number of visits and the total duration of the study will depend on the specific part of the study you are in and how you respond to the treatment, but these details will be explained clearly if you are considered for participation.

After you finish your treatment period, there will be a follow-up period where the study team will continue to monitor your health. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and experimental treatment that might help reduce the size of your tumour or improve your symptoms – though this is not guaranteed. You will also be closely monitored by medical professionals. However, there are potential risks, including side effects from the medicines, which can range from mild to severe, and may require additional medical attention. You might also need to attend many clinic visits, which can take time and effort. It's important to remember that you can stop participating in the study at any time, for any reason, without having to explain why, and your decision will not affect your ongoing medical care.

Locations (4)

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

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Unverified
France
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Unverified
Italy
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Unverified
Netherlands
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Unverified
Germany

Common questions

What is a 'Phase 2' study?

A Phase 2 study is an early stage of research where doctors test a new treatment on a small group of people to see if it's safe and if it shows signs of working well, before testing it more widely.

What kind of cancer is this study for?

This study is for people with certain 'solid tumours,' which are cancers that form solid lumps in the body. Your doctor will be able to tell you if your specific cancer type is included.

What are MK-4280A and pembrolizumab?

MK-4280A is a new combination of two medicines (favezelimab and pembrolizumab). Pembrolizumab is a known cancer drug, sometimes called KEYTRUDA, that helps your body’s immune system fight cancer.

Will I definitely get the new combined medicine?

This study might randomly assign you to receive the new combined medicine or another established treatment like Lenvatinib. The doctors will explain which group you are in.

How long will I be in the study?

The length of time you'll be in the study can vary. It depends on how you respond to the treatment and the specific part of the study you're in. This will be fully explained to you before you consent.