Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 with Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer (KEYVIBE-003)

This study, called KEYVIBE-003, is investigating a new treatment approach for advanced non-small cell lung cancer that has spread (stage IV). Researchers are comparing a new combination medicine, MK-7684A, which includes Keytruda, against Keytruda alone. The main goal is to see if this new combination helps patients live longer, especially those whose cancer has high levels of a specific marker called PD-L1. They will also look at how long people live without their cancer growing, how many people see their cancer shrink or disappear, how long those improvements last, and how the treatments affect their general health and quality of life, including symptoms like cough and chest pain. This is a Phase 3 study, meaning it’s a later stage trial to confirm if the new treatment is effective and safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

156

Start

23 Oct 2023

Stage IV non small-cell lung cancer

What is this study about?

This study, known as KEYVIBE-003, focuses on people with a type of lung cancer called non-small cell lung cancer that has spread to other parts of the body (this is called Stage IV or metastatic). Specifically, it’s for patients whose cancer has high levels of a particular protein marker called PD-L1. This marker helps doctors understand how likely a cancer is to respond to certain treatments, like Keytruda, which is a type of immunotherapy.

The main purpose of this study is to compare two treatments: Keytruda by itself, and a new combination called MK-7684A. MK-7684A actually contains Keytruda alongside another experimental medicine. Researchers want to find out if this new combination works better than Keytruda alone in helping people live longer. They will also investigate if it can stop the cancer from growing for longer, if more people see their tumours shrink, and how the treatments affect day-to-day life and symptoms like coughing or chest pain.

This is a Phase 3 study, which means it’s one of the last steps before a new medicine might be approved for wider use. It's designed to confirm whether the new treatment is both effective and safe for patients. The information gathered will be crucial in understanding how to best treat non-small cell lung cancer for people with this specific PD-L1 marker.

Key takeaways

This study is for advanced non-small cell lung cancer with PD-L1 markers.
It compares a new combination treatment (MK-7684A) to Keytruda alone.
The main goal is to see if the new combination helps people live longer.
It also looks at how treatments affect cancer growth, tumour shrinkage, and quality of life.
Participation involves regular clinic visits, treatments, and health assessments.
You can stop participating at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, participants generally need to be 18 years old or older. The study is open to both men and women.

Your doctor will need to perform specific tests to confirm that you have non-small cell lung cancer that has spread (Stage IV). A key part of qualifying is that your cancer cells must show a certain amount of the PD-L1 marker.

There might be other health checks or conditions that determine if you can join, such as your overall health and if you’ve had certain other treatments in the past. Your doctors will discuss all these details with you to see if this study is suitable.

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 non-small cell lung cancer that has spread (Stage IV)?
Have tests shown your cancer has the PD-L1 marker?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either the new combination medicine (MK-7684A) or Keytruda on its own. You won't get to choose which one you receive. This is done to ensure the study is fair and unbiased.

Taking part will involve regular visits to the clinic for your treatments and check-ups. During these visits, doctors and nurses will monitor your health, check for side effects, and carry out various tests, such as blood tests and scans, to see how your cancer is responding. You will also be asked to complete questionnaires about your general health and how you feel, which helps the researchers understand the impact of the treatment on your quality of life.

The treatment period will last as long as the treatment is helping you and you are tolerating it well. After the treatment phase, there will be a follow-up period where doctors will continue to monitor your health remotely or through occasional visits. The total duration of your participation, including follow-up, could be several years.

Potential risks and benefits

While we cannot make medical recommendations, it's important to understand the potential aspects of taking part in a clinical trial. Potential benefits could include access to a new treatment, MK-7684A, before it's widely available. This treatment might be more effective than existing options for your type of cancer. You would also receive close medical attention and monitoring throughout the study. However, there are potential risks, as with any medical treatment. The new combination medicine might have side effects that are different from or more severe than those of Keytruda alone. There's also no guarantee that the new treatment will be effective for you. You will be fully informed about all known side effects before you agree to participate, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual 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
Romania
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Unverified
Hungary

Common questions

What is PD-L1 and why is it important?

PD-L1 is a protein found on some cancer cells. Its presence can help doctors decide if certain immunotherapy treatments, like Keytruda, might work for you. In this study, it helps decide if you can participate.

What does 'Stage IV' lung cancer mean?

Stage IV means the lung cancer has spread from where it started to other parts of your body. This is also called metastatic cancer.

What is the difference between MK-7684A and Keytruda?

Keytruda is an existing medicine. MK-7684A is a new combination treatment that includes Keytruda along with another experimental medicine, all given together.

Will I know which treatment I am receiving?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving MK-7684A or Keytruda alone. This helps ensure the study results are fair.

What does quality of life mean in this study?

Quality of life refers to your general well-being and how you feel physically and emotionally. The study will ask about symptoms like cough, chest pain, and your ability to do daily activities.