Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C4221023 - A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS NIVOLUMAB AND IPILIMUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE MELANOMA WHO PROGRESSED DURING OR AFTER PRIOR TREATMENT WITH ANTI−PD-1 THERAPY

This study is for people in the UK with advanced melanoma, a serious skin cancer, that has a specific genetic change called BRAF V600E/K. Participants chosen for this study have already received treatment with anti-PD-1 medicines, but their cancer has either grown or didn't get better. The study aims to find out if new combinations of drugs can improve how well the treatment works. One group will receive encorafenib and binimetinib combined with pembrolizumab. The other group will receive nivolumab and ipilimumab. The main goal is to see which combination shrinks the cancer more effectively and for how long. It's an important step in finding better ways to treat this type of melanoma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

119

Start

07 Jun 2024

Metastatic or unresectable locally advanced BRAF V600E/K mutation positive melanoma

What is this study about?

This research study is looking for new and better ways to treat a type of skin cancer called melanoma. Specifically, it's for melanoma that has spread to other parts of the body (metastatic) or can't be removed by surgery (unresectable locally advanced). Your doctor might call this 'advanced melanoma'.

To be part of this study, your melanoma must have a specific genetic change called a 'BRAF V600E/K mutation'. This is important because some medicines work by targeting this exact change. Also, you must have already been treated with a type of medicine called 'anti-PD-1 therapy' (like pembrolizumab or nivolumab), but your cancer either started to grow again or didn't get better with that treatment.

The study will compare two different groups of drug combinations. One group will get a combination of three drugs: encorafenib, binimetinib, and pembrolizumab. The other group will get two drugs: nivolumab and ipilimumab. The main purpose is to see how well these different combinations shrink the cancer, how long their effect lasts, and how people feel while taking them. This kind of study helps doctors understand which treatments are most effective and safe for patients in the future.

Key takeaways

This study is testing new drug combinations for advanced melanoma with a specific gene change.
It's for people whose cancer didn't respond well to previous anti-PD-1 treatments.
Participants will receive one of two specific drug combinations.
The main goal is to see which treatment shrinks the cancer best.
Regular hospital visits, tests, and questionnaires are part of taking part.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

Key conditions for joining include having advanced melanoma that has a specific gene change called BRAF V600E/K. You must also have tried anti-PD-1 treatments before, but your cancer didn't respond or started to grow again.

The study team will check your full medical history and do some tests to make sure it's safe for you to take part and that you meet all the necessary requirements.

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 melanoma that has the BRAF V600E/K gene change?
Has your melanoma been treated with an anti-PD-1 medicine (like nivolumab or pembrolizumab) before?
Did your cancer not respond well to that previous anti-PD-1 treatment, or did it start growing again?
Are you able to attend regular hospital visits for tests and treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned by chance to one of two treatment groups, like flipping a coin. You won't get to choose which group you're in. You'll receive specific study medications as part of your assigned treatment group.

You will need to visit the hospital or clinic regularly. These visits will involve blood tests, physical exams, and scans (like CT or MRI) to see how the treatment is affecting your cancer. You will also be asked to fill out questionnaires about your quality of life. The study will continue for a certain period, and you will have follow-up appointments even after you stop taking the study medication. The total time you're involved could be several months to a few years, depending on how you respond to the treatment and the study plan.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from receiving new treatments that aren't yet widely available, and this could help control your cancer. However, there's also a chance the treatment might not work for you, or you could experience side effects. These side effects can range from mild, like tiredness or nausea, to more serious. The study team will closely monitor you and discuss all known risks. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (5)

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
Germany
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Unverified
Slovakia
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Unverified
Italy
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Unverified
Poland

Common questions

What is advanced melanoma?

Advanced melanoma means the skin cancer has spread to other parts of your body or can't be removed by surgery.

What does 'BRAF V600E/K mutation' mean?

It's a specific change in your cancer cells' genes that the study drugs might target. Your doctor will have tested for this.

Why are there different drug combinations?

The study aims to compare two new sets of treatments to see which one works better for people struggling with this type of melanoma.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which specific drugs you are receiving.

What happens if I want to stop participating?

You can leave the study at any time, and it won't affect your future medical care. Just talk to your study doctor.