An Open-Label, Multicentre Phase 1b/2a Clinical Trial of BI-1607, an Fc-Engineered Monoclonal Antibody to FcγRIIB (CD32b), in Combination with Ipilimumab and Pembrolizumab in Participants with Unresectable or Metastatic Melanoma
This study is looking at new ways to treat advanced melanoma, a serious type of skin cancer that has spread or cannot be removed by surgery. Researchers are testing a new medicine called BI-1607 together with two existing cancer drugs, Keytruda and Yervoy. The main goals are to find out if this combination of medicines is safe, what side effects it might cause, and how well it works to shrink tumours or stop the cancer from growing. This is an early-stage study, meaning it's one of the first times this new combination is being tested in people with melanoma to learn more about its effects.
At a glance
What is this study about?
This research study is about finding new and better ways to treat a type of skin cancer called melanoma, specifically when it's advanced. Advanced melanoma means the cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). It's a serious condition, and doctors are always looking for more effective treatments.
In this study, doctors are testing a new medicine called BI-1607. This new medicine will be given alongside two other treatments that are already used for melanoma: Keytruda (pembrolizumab) and Yervoy (ipilimumab). Both Keytruda and Yervoy are powerful drugs that help your body's immune system fight cancer. The researchers want to see if adding BI-1607 can make these existing treatments even better at fighting melanoma.
The study has two main parts, called Phase 1b and Phase 2a. In Phase 1b, the focus is mainly on safety and finding the right dose for the new treatment combination. They will carefully watch for any serious side effects. In Phase 2a, they will look at how well the treatment works to shrink tumours and how long people live without their cancer getting worse, while still keeping a close eye on safety and side effects. By doing this research, they hope to improve future treatments for people with advanced melanoma.
Key takeaways
- This study is testing a new combination of medicines for advanced melanoma.
- It combines a new drug (BI-1607) with two existing immune therapies (Keytruda, Yervoy).
- The main goals are to check for safety, side effects, and how well the treatment shrinks tumours.
- Participation involves regular clinic visits, blood tests, scans, and heart checks.
- This is an early-stage study, aiming to find better future treatments for melanoma.
Who may be eligible?
To be considered for this study, participants must be at least 18 years old. Both men and women can take part.
There will be other important health requirements that a study doctor will discuss with you. These are put in place to ensure your safety and that the study results are as clear as possible.
It's important to understand that not everyone who wants to join a clinical trial will be able to. Your doctor will need to check your medical history and do some tests to see if this study is right for 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 aged 18 or older?
- Do you have melanoma that has spread or cannot be removed by surgery?
- Are you able to attend regular hospital or clinic appointments?
- Are you willing to follow all study procedures and take the study medication as instructed?
- Have you discussed your other health conditions and medicines with your doctor?
What does participation involve?
If you decide to take part in this study, you will receive a combination of three medicines: the new drug BI-1607, along with Keytruda and Yervoy. These medicines are given as infusions, which means they go directly into your bloodstream through a drip, likely in a hospital or clinic setting.
Throughout the study, you will have regular visits to the clinic. During these visits, the study team will carry out various assessments. This includes physical examinations, taking blood and urine samples, checking your vital signs like blood pressure and heart rate, and performing heart tests (ECGs). They will also do scans to see how your cancer is responding to the treatment.
The doctors will closely monitor you for any side effects and how well the treatment is working. The frequency and duration of these visits and treatments will be explained in detail by the study team. You might also have breaks in treatment or changes to your dose if needed. The total length of your participation will depend on how you respond to the treatment and the study's design.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is melanoma?
Melanoma is a serious type of skin cancer that starts in the cells that give your skin its colour. Advanced melanoma means it has spread to other parts of your body or can't be removed by surgery.
What are Keytruda and Yervoy?
Keytruda and Yervoy are types of medicines called immunotherapy. They work by boosting your body's own immune system to find and fight cancer cells.
What does 'unresectable' mean?
Unresectable means that the cancer cannot be completely removed by surgery, often because of its size or location.
What is a 'Phase 1b/2a' study?
This refers to the stage of the clinical trial. Phase 1b is an early stage focused on safety and finding the right dose. Phase 2a then looks at how well the treatment works, while still monitoring safety.
Will I know which treatment I'm getting?
Yes, in this open-label study, both you and your doctor will know that you are receiving all three study medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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