Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants with Previously Untreated Unresectable or Metastatic Melanoma

This research study is investigating a new medication called RO7247669 for individuals with advanced melanoma skin cancer. This is for melanoma that has spread to other parts of the body (metastatic) or cannot be surgically removed (unresectable). It's a 'Phase II' study, which means it's an early step to see how well the treatment works and how safe it is in a larger group of people. Researchers will be carefully monitoring participants to see if the new medicine can control the cancer's growth, shrink tumours, and how long people stay well. They will also be tracking any side effects to understand the medicine better. This study is ‘open-label,’ meaning both the participants and the doctors will know who is receiving the new medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

29 Jan 2024

Unresectable or Metastatic Melanoma

What is this study about?

This research study is exploring a new medicine called RO7247669 for people with a type of skin cancer called melanoma. Specifically, it's for melanoma that has spread to other parts of the body (known as metastatic melanoma) or can't be removed completely by surgery (unresectable melanoma). This is an important step in finding new treatments for this challenging condition.

The main goal of this study is to see how effective the new medicine, RO7247669, is at slowing down or stopping the cancer from getting worse. Doctors will especially be looking at something called 'progression-free survival.' This means they'll measure how long participants live without their cancer getting worse or spreading further. They will also be closely watching for any changes in the size of the tumours.

Another key part of the study is to understand the safety of RO7247669. The research team will be carefully monitoring and recording any side effects that people experience. They'll also be looking at how the medicine works in the body and if it triggers any immune responses. By gathering all this information, researchers hope to learn if RO7247669 could be a helpful new treatment option for people living with advanced melanoma.

Key takeaways

This study is for advanced melanoma that hasn't been treated before.
It's testing a new medicine called RO7247669.
The main goals are to see how well the medicine controls cancer growth and what its side effects are.
Participation involves regular hospital visits for checks and tests.
You can stop taking part at any time without affecting your normal care.

Who may be eligible?

This study is looking for adults who are at least 18 years old.

You might be able to take part if you have melanoma skin cancer that has spread to other parts of your body or can't be removed by an operation, and you haven't had any treatment for this advanced melanoma yet.

There will be other detailed health checks to make sure the study is right and safe for you. The study team will discuss these with you.

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 melanoma that has spread or cannot be removed by surgery?
Have you not received any previous treatment for this advanced melanoma?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, RO7247669. Both you and your doctors will know you are receiving this specific treatment. You would have regular visits to the hospital or clinic, where doctors will check your general health, measure your tumours, and monitor your blood for any changes or side effects. You might have scans to check the cancer's progress and blood tests to see how the medicine is working in your body. The study team will explain exactly what each visit involves and how long you might be in the study, including any follow-up after the main treatment period.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new medicine that isn't widely available yet, which might help your condition. It also contributes valuable information that could help others in the future. However, there are potential risks, as any new medicine can have side effects that are not fully known. These side effects could range from mild to serious. The research team will explain all known potential side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Poland
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Unverified
Greece
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Unverified
Slovakia
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Unverified
Czechia
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Unverified
Spain

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in cells that make pigment. It can spread to other parts of the body if not caught early.

What does 'unresectable' or 'metastatic' mean?

Unresectable means the cancer can't be completely removed by surgery. Metastatic means the cancer has spread from where it started to other parts of the body.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research. It mainly checks if a new medicine works and is safe in a larger group of people, after initial safety checks.

Will I know if I'm getting the new medicine?

Yes, this is an 'open-label' study, which means both you and your doctors will know that you are receiving the new medicine, RO7247669.

How long will I be in the study?

The study team will explain the expected duration of treatment and follow-up visits, which will depend on your individual response and progress.