Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2 Open-label, Rolling-arm, Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYMAKER-U02): Substudy 02A

This research study, called KEYMAKER-U02, is looking at new ways to treat advanced melanoma, a type of skin cancer, when it has become resistant to standard immune-boosting treatments like pembrolizumab. The study is trying out different combinations of existing and new medicines, including Lenvatinib, quavonlimab, TRETINOIN, and pembrolizumab (KEYTRUDA), to see which ones are safe and effective. Researchers are particularly interested in finding out if these treatments can reduce the size of tumours. This is an early-stage study, open to adults aged 18 and over, and will help doctors understand more about these potential new treatments for melanoma.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

04 Dec 2023

PD-1 refractory melanoma

What is this study about?

This study, known as KEYMAKER-U02, is designed to investigate potential new treatments for melanoma, a serious form of skin cancer. Specifically, it's for people whose melanoma has already been treated with certain immune therapies (like pembrolizumab), but the cancer has unfortunately started to grow again or hasn't responded well. This type of melanoma is called 'PD-1 refractory'.

The study aims to test several different medications, some on their own and others in combination with pembrolizumab. The new medicines being looked at include Lenvatinib, quavonlimab, and vibostolimab, alongside TRETINOIN. The main goal is to find out if these new treatments are safe for patients and if they can shrink the tumours or stop them from growing. Researchers will carefully monitor participants for any side effects and see how their cancer responds to the treatment.

By taking part in a study like this, you would be helping doctors and scientists learn more about new ways to fight melanoma. This information is vital for developing better treatments in the future, especially for situations where existing therapies are no longer working effectively.

Key takeaways

This study is for advanced melanoma that hasn't responded to previous immune therapy.
It tests new combinations of medicines to find out if they are safe and effective.
Participation involves regular hospital visits, tests, and receiving study medication.
It's an early-stage study focusing on safety and how well the treatments work.
You'll know which treatment you are receiving (open-label study design).
Both men and women aged 18 and over can participate.

Who may be eligible?

This study is open to adults over 18 years of age. Both men and women can take part.

To be eligible, you must have advanced melanoma that has previously been treated with pembrolizumab (or a similar medicine) and is no longer responding to that treatment. Your medical team will perform specific tests to confirm that your melanoma fits the criteria for this study.

There will also be other health requirements, such as normal organ function and a general good state of health, which your doctor will discuss with you. These checks are in place to ensure your safety throughout the study.

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 advanced melanoma?
Has your melanoma been treated with pembrolizumab (or a similar immune therapy) before?
Is your melanoma no longer responding to that previous immune therapy?
Are you able to attend regular hospital appointments for treatment and tests?
Are you generally in good health, apart from your melanoma?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive one of the investigational treatments, either on its own or in combination with pembrolizumab, through infusions or by taking tablets. The treatment schedule and how often you'd need to visit the hospital would depend on which specific treatment arm you are in.

Throughout the study, you would have regular appointments, blood tests, and scans (like CT scans or MRI scans) to monitor your health, check for any side effects, and see how the treatment is affecting your melanoma. You would also have regular check-ups with the study doctors and nurses. The total length of your participation would depend on how you respond to the treatment and the study's design.

Potential risks and benefits

Taking part in a clinical trial involves both potential benefits and risks. You might benefit from a new treatment for your melanoma that isn't yet widely available, and your health will be closely monitored. However, there's no guarantee the treatment will work for you, and you might experience side effects, some of which could be serious. The study team will explain all known side effects before you decide to participate. You are free to withdraw from the study at any time, for any reason, without it 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
France
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Unverified
Italy

Common questions

What is 'PD-1 refractory melanoma'?

This means your melanoma has been treated with a type of immune therapy called a PD-1 inhibitor (like pembrolizumab), but it's no longer responding to that treatment.

What are 'investigational agents'?

These are new medicines or treatments that are still in the testing phase and are not yet approved for general use. They need to be studied to make sure they are safe and effective.

What is a 'Phase 1/2' study?

This means it's an early-stage study. Phase 1 focuses on safety, checking for side effects and finding the right dose. Phase 2 then looks at whether the treatment works to shrink or control the cancer.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know exactly which combination of medicines you are receiving.

What happens after the study ends?

Once your participation in the treatment part of the study finishes, the study team will continue to monitor your health and how your cancer is doing for a certain period. They will discuss your ongoing care plan with you.