Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Clinical Study to Evaluate the Safety and Efficacy of MK-1308A (Coformulated MK-1308/MK-3475) in Combination with Lenvatinib (E7080/MK-7902) in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma

This study is focusing on people with a type of advanced liver cancer called hepatocellular carcinoma, who are starting their first treatment. We are exploring a new combination of medicines to see how safe and effective they are. The new combination includes a drug known as MK-1308A, which is actually two medicines (MK-1308 and MK-3475, also known as KEYTRUDA) mixed together, plus Lenvatinib. Researchers want to find out how many people experience side effects, how serious those side effects are, and if the treatment helps to shrink the cancer or stop it from growing. This is a "Phase 2" study, meaning it’s an earlier stage of research looking into how well a new treatment works and if it's safe enough to study further.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

27 Jul 2023

Hepatocellular carcinoma

What is this study about?

This research study is about finding better ways to treat a type of liver cancer that has spread or is advanced, called hepatocellular carcinoma. This specific study is for people who are starting their very first treatment for this condition.

The main goal is to test a new combination of medicines. This combination involves a drug called KEYTRUDA (its full trial name is MK-3475), another experimental medicine called MK-1308, and an existing treatment called Lenvatinib. Researchers want to carefully watch how people respond to this combination. They will be looking at how safe the treatment is – meaning, what kind of side effects it might cause and how often they happen. They also want to see how well it works to control the cancer, such as if it helps to slow its growth or even shrink it.

Studies like this are very important because they help us find new and potentially more effective treatments for serious illnesses. By understanding both the safety and the effects of these new drug combinations, doctors can decide if they could be good options for future patients. Participating in a study like this helps advance medical science and could lead to new breakthroughs.

Key takeaways

It's a study for advanced liver cancer (hepatocellular carcinoma).
It's for people starting their first treatment for this condition.
It tests a new combination of drugs, including KEYTRUDA.
The main goals are to check for safety and how well the treatment works.
It's a Phase 2 study, an early stage in researching new treatments.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. There is no upper age limit, so older adults can also be considered.

This study is open to everyone, regardless of whether you are male or female.

The most important thing is that you have advanced hepatocellular carcinoma, which is a type of liver cancer that has spread or is quite advanced, and you haven't started treatment for it yet. Your doctor will carefully check if your overall health and your specific cancer type meet all the other detailed requirements for joining.

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 advanced hepatocellular carcinoma (a type of liver cancer)?
Have you not yet received any treatment for this advanced liver cancer?
Are you willing to discuss the study details with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medications: Lenvatinib and MK-1308A (which is KEYTRUDA combined with MK-1308). You would have regular visits to the hospital or clinic for check-ups, blood tests, and scans. These visits are important for the doctors to monitor your health, how you are reacting to the treatment, and how your cancer is responding. The doctors will especially be looking for any side effects and carefully recording them. The total duration of your participation would depend on how your treatment is going and how your body responds.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could help your condition. However, new treatments can have side effects, and some might be serious. The medical team will closely monitor you to manage any side effects. Remember, joining this study is completely your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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
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Unverified
Poland

Common questions

What kind of cancer is this study for?

This study is for advanced hepatocellular carcinoma, which is a type of liver cancer that has spread or is quite advanced.

What medicines are being tested?

The study is testing a combination of medicines: Lenvatinib and MK-1308A, which includes KEYTRUDA.

Will I be getting a new treatment or a standard one?

You will be getting a new combination of treatments that aren't yet standard for first-line therapy in this disease.

What does 'Phase 2' mean?

Phase 2 means it's an earlier stage of research. Doctors are looking at how safe the new treatment is and if it shows promise in helping patients.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, without it affecting your future medical care.