Active not recruitingPHASE2INTERVENTIONAL

Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations

This study is testing two new medicines, binimetinib and encorafenib, for adults with advanced cancers that haven't responded to standard treatments. It's for people whose cancers have certain genetic changes called 'non-V600E BRAF mutations.' The main goal is to see how effectively these drugs can shrink the cancer (this is called the objective response rate). Participants will take these medicines daily by mouth. This research hopes to find better ways to treat these specific types of cancer, as these BRAF mutations are known to make cancers harder to treat and have worse outcomes. Researchers will regularly monitor patients' health and tumor changes throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

Start

07 Jun 2019

Estimated completion

01 Dec 2026

Solid Tumor

What is this study about?

This study is looking at two new medications, binimetinib and encorafenib, for adult patients who have advanced cancer that has either come back after past treatments or for which no standard treatment is available. The research specifically focuses on cancers with certain genetic changes, called 'non-V600E BRAF mutations'. These particular BRAF mutations can make cancers grow faster and are often harder to treat effectively. The medications aim to block specific processes within the body that help these mutated cancer cells grow.

Binimetinib blocks a protein called MEK, which is involved in a cancer-promoting pathway in the body. Encorafenib targets a different protein, BRAF V600-mutant kinase, which is also part of this same pathway. By blocking these proteins, both drugs try to stop the cancer from growing and spreading. Researchers hope that combining these two drugs will be more effective than current treatments for cancers with these specific BRAF mutations.

The main goal of this study is to see how many patients experience their tumors shrinking or disappearing after taking these drugs. This is an important step in figuring out if these medications could be a new treatment option for people with these specific types of cancer. If successful, this research could lead to improved outcomes for patients with these challenging forms of cancer.

Key takeaways

Tests two new drugs for advanced cancers with specific gene changes.
Focuses on 'non-V600E BRAF mutations'.
Drugs are taken daily by mouth.
Aims to see how much the tumors shrink.
Requires regular clinic visits and various tests.
Open to adults over 18 who meet specific health criteria.

Who may be eligible?

To join this study, you need to be an adult over 18 years old. Your cancer must be advanced, meaning it has spread or can't be cured with standard treatments, or if there are no other treatments available. Your cancer also needs to have specific genetic changes called 'non-V600E BRAF mutations' – these will be checked by the study doctors.

You must be able to swallow pills and be willing to come to regular clinic visits. It’s also important that you agree to have blood tests and possibly tumor biopsies (small tissue samples) taken throughout the study. Your general health, including how well your organs are working, will be checked to make sure it's safe for you to participate.

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 over 18 years old?
Do you have an advanced solid cancer that has not responded to other treatments or for which no standard treatment exists?
Has your doctor confirmed your cancer has a 'non-V600E BRAF mutation'?
Are you able to swallow pills and attend regular clinic appointments?
Are you willing to have blood tests and potentially biopsies?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take two medications, binimetinib and encorafenib, daily by mouth. You'll have regular visits to the clinic, typically up to twice every four weeks. During these visits, the study team will review your health and any side effects you might be having. You'll also have various tests, which may include blood tests for safety and research, urine tests, heart scans (ECGs and MUGA scans), eye exams, and imaging scans (like CT or MRI) to check on your cancer. You may also be asked to provide biopsies (small tissue samples) before and during treatment. The specific duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit if these new drugs are effective in treating your specific type of cancer, especially if other treatments haven't worked. However, there's no guarantee the drugs will help. Like all medications, binimetinib and encorafenib can have side effects, which the study team will discuss with you. You'll be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid cancers that have specific 'non-V600E BRAF mutations' and where standard treatments haven't worked or aren't available.

What are BRAF mutations?

BRAF mutations are specific changes in a gene that can make cancer cells grow. This study is looking at particular types of these mutations that are harder to treat.

How will I take the study drugs?

You will take both binimetinib and encorafenib daily by mouth, as pills or capsules.

Will I have to have biopsies?

Yes, you will need to provide at least one biopsy before starting treatment. For some patients, additional biopsies during treatment may also be required.

How long will I be in the study?

The length of your participation will depend on how your cancer responds to the treatment and your overall health.