Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination with Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients with NRAS-Mutant Advanced Melanoma

This research is testing new drug combinations for people with a type of advanced skin cancer called melanoma. Specifically, it's for those whose melanoma has a genetic change known as an NRAS mutation. The study is investigating a new drug called belvarafenib, either on its own or in combination with other medicines like cobimetinib, or with both cobimetinib and nivolumab. This is an early stage (Phase 1) study, which means the main goals are to understand how safe these treatments are, how the body handles them, and to see if they show any signs of helping to fight the cancer. Participants will be aged 18 or over, and both men and women can take part. The aim is to find better ways to treat this specific type of advanced melanoma.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Genentech Inc.

Enrolment target

Start

30 Nov 2023

NRAS-mutant advanced cutaneous melanoma

What is this study about?

This study is an important step in trying to find new and better treatments for advanced melanoma, a serious type of skin cancer. Specifically, it focuses on patients whose melanoma has a particular genetic fault, called an NRAS mutation. These kinds of mutations can sometimes make cancer harder to treat with standard therapies, so researchers are always looking for new options.

The main medicines being tested are belvarafenib, cobimetinib, and nivolumab, either alone or in different combinations. Belvarafenib is a new drug, and cobimetinib and nivolumab are existing cancer medicines. The study is in its very early stages (what scientists call Phase 1). This means the main goals are to make sure the treatments are safe, to understand how they behave in the body, and to see if there are any early signs that they might be effective in fighting the cancer.

Finding new treatments for specific types of cancer, like NRAS-mutant melanoma, is really important. It helps doctors move towards more personalised medicine, where treatments are tailored to the individual patient’s cancer. This research aims to gather crucial information that could lead to bigger studies and, hopefully, new approved treatments for patients in the future.

Key takeaways

This study is testing new treatments for advanced melanoma with a specific NRAS gene change.
It's an early-stage study focusing on safety and how the new drugs work.
Participants must be 18 or older with advanced NRAS-mutant melanoma.
Regular clinic visits, blood tests, and scans will be part of participation.
Potential benefits include access to new treatments, but risks of side effects exist.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women can take part. The study is specifically for people who have advanced melanoma, which is a type of skin cancer that has spread.

Importantly, your melanoma must have a specific genetic change called an NRAS mutation. Doctors will usually test for this mutation to help decide the best treatment for you. This study is not for other types of cancer or for melanoma without this particular mutation.

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 doctor confirmed your melanoma has an NRAS mutation?
Are you able to attend regular clinic visits for tests and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication (belvarafenib, cobimetinib, or nivolumab, depending on your assigned group) according to a set schedule. You would have regular visits to the clinic for various assessments. These assessments typically include physical examinations, blood tests, and scans (like CT scans or MRI scans) to monitor your health and how the treatment is working. The study team will explain how often these visits and tests would happen. The total length of your participation would depend on how your body responds to the treatment and the study's design, but the doctors will always keep you informed.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new treatment before it's widely available, which might help your condition. However, new medications can have side effects, and some may be unpleasant or serious. The study team will carefully monitor you for any side effects and provide support. Your safety and well-being are the top priority. It's important to remember that 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
Germany
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Unverified
Norway

Common questions

What is advanced melanoma?

Advanced melanoma is a type of skin cancer that has spread from where it first started to other parts of the body.

What does 'NRAS mutation' mean?

An NRAS mutation is a specific change in the genes of your melanoma cancer cells. Doctors test for this to understand your cancer better and help guide treatment options.

What is a Phase 1 study?

A Phase 1 study is an early stage of clinical research. Its main goal is to check how safe a new medicine is, how it affects the body, and to find the right dose. It's not primarily focused on whether the medicine cures the disease, though early signs of benefit are always looked for.

Will I know which drug I'm receiving?

The study team will explain the specific treatment plan for your group, including which medications you would be receiving, if you decide to join.

How long would I be in the study?

The length of time you'd be in the study can vary. It depends on how you respond to the treatment and the overall study plan. The study team will discuss this in detail with you.