Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multicenter, Open-label, Phase 2 Basket Study of MK‑7684A, a Co formation of Vibostolimab (MK‑7684) With Pembrolizumab (MK‑3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (KEYVIBE 005)

The KEYVIBE 005 study is a Phase 2 clinical trial looking into a new treatment called MK-7684A. This treatment is a combination of two existing medicines, vibostolimab and pembrolizumab, for people who have advanced solid tumours. The main goal is to find out how effective this new combination is at shrinking tumours and slowing down their growth. This could mean using MK-7684A on its own or alongside other common cancer treatments like chemotherapy or targeted therapies such as Lenvatinib. Researchers will also be checking for side effects and how the treatment affects participants' quality of life. This trial aims to gather important information to help manage advanced cancers better in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

228

Start

06 Feb 2024

Advanced solid tumors

What is this study about?

This study, known as KEYVIBE 005, is a Phase 2 clinical trial. This means it's one of the earlier stages of testing a new treatment, focusing on whether it's safe and effective, and finding the right dose. The main treatment being investigated is a new combination called MK-7684A. This is actually two anti-cancer medicines, vibostolimab and pembrolizumab, brought together. Pembrolizumab, also known as Keytruda, is an immunotherapy medicine already used for many cancers. Vibostolimab is another immunotherapy that helps the body's immune system fight cancer.

The trial is for people with what doctors call 'advanced solid tumours.' This refers to cancers that have grown or spread. The researchers want to see how well MK-7684A works to shrink these tumours and stop them from growing. They are testing it in different ways: sometimes MK-7684A will be given by itself, and sometimes it will be combined with other standard cancer treatments you might already know, such as different types of chemotherapy (like Paclitaxel or Carboplatin) or other targeted drugs (like Lenvatinib or Bevacizumab).

Measuring how well the treatment works is a crucial part of the study. Doctors will regularly check the size of the tumours to see if they are getting smaller or if their growth has slowed down or stopped. They will also keep a close eye on any side effects and how participants feel overall, including their general health and quality of life. The information from this study will help doctors understand if this new combination could become a valuable treatment option for people with certain advanced cancers.

Key takeaways

Tests a new combination treatment called MK-7684A (vibostolimab + Keytruda).
For adults with advanced solid tumours.
May be given alone or with other standard cancer medicines.
Aims to check treatment effectiveness, safety, and impact on quality of life.
Requires regular hospital visits and medical monitoring.

Who may be eligible?

To join this study, participants generally need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Since this trial is for 'advanced solid tumours,' you would need to have a specific type of cancer that has either spread or is difficult to treat with standard methods. The doctors running the study will review your medical history and test results very carefully to make sure the study is a good fit for you.

There will be other detailed medical criteria that only a doctor can properly explain and check, such as your general health, how well your organs are working, and if you have any other serious medical conditions. This is to ensure your safety throughout the trial.

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 an advanced solid tumour diagnosis?
Are you able to travel to study visits regularly?
Are you willing to undergo regular medical tests and scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the investigational treatment, MK-7684A, possibly combined with other approved cancer medicines. These treatments are typically given as infusions into a vein, which means you would need to visit the hospital or clinic regularly. The frequency and duration of these visits would depend on the specific treatment plan you are assigned to.

Throughout the study, you would have regular medical check-ups, blood tests, and scans (like CT or MRI scans) to monitor your tumour's response and your general health. You would also be asked to complete questionnaires about how you are feeling and your quality of life. The doctors and nurses would be in close contact to manage any side effects you might experience.

Participation could last for several months, or even longer, depending on how your body responds to the treatment and the study's specific design. There would also be a period of follow-up after your treatment finishes to monitor your long-term health. All travel costs and expenses related to your participation in the study would usually be covered.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new and innovative treatment that might be more effective than existing options, especially if your cancer has not responded to previous treatments. You would also have very close medical monitoring. However, there are potential risks, as new treatments can have side effects that are not yet fully known or can be more severe than standard treatments. The investigational drugs might not work for you, or they might not work as well as expected. It's important to understand that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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
Germany
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Unverified
Poland
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Unverified
France
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Unverified
Netherlands

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 or are difficult to treat with current methods.

What is MK-7684A?

MK-7684A is a new combination treatment being tested. It contains two immunotherapy medicines: vibostolimab and pembrolizumab (also known as Keytruda).

Will I get other treatments?

Yes, you might receive MK-7684A on its own, or it might be given alongside other common cancer treatments like certain types of chemotherapy or targeted therapies.

What does a 'Phase 2' study mean?

A 'Phase 2' study aims to see if a new treatment is safe and effective enough to be tested on a larger scale. It also helps find the best dose.

Will I have to spend a lot of time at the hospital?

You will need regular visits to the hospital or clinic for treatment infusions, check-ups, and tests. The exact number of visits will be explained to you.