Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma

This research is looking into a new treatment approach for advanced melanoma, a type of skin cancer that has spread or can't be removed by surgery. The study involves a new drug called BI-1607, which is given alongside two established melanoma treatments: pembrolizumab (Keytruda®) and ipilimumab (Yervoy™). The main goals are to check how safe this combination is, find the best doses for these drugs, and see if this three-drug treatment can shrink tumours more effectively. Researchers hope BI-1607 will help the body's immune system fight cancer cells better when used with the other two drugs, offering a new option for patients whose cancer hasn't responded to standard treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

BioInvent International AB

Enrolment target

Start

11 Dec 2024

Estimated completion

30 Dec 2025

Melanoma Metastatic Melanoma of Skin Melanoma BRAF V600E/K Mutated Melanoma Recurrent Melanoma Stage III or IV Melanoma Melanoma Negative for bRAF Melanoma Negative for nRAS Melanomas Uveal Melanoma, Metastatic

What is this study about?

This research study is focused on improving treatment for a type of skin cancer called melanoma, especially when it has spread to other parts of the body or can't be removed by surgery. Melanoma starts in the cells that give skin its colour. Sometimes, when standard treatments haven't worked well, doctors and researchers look for new ways to fight the cancer. That's exactly what this study aims to do.

The study introduces a new drug called BI-1607. This new drug is being tested alongside two medicines already used to treat melanoma: pembrolizumab (known as Keytruda®) and ipilimumab (known as Yervoy™). The idea is that BI-1607 might make these existing treatments work even better by boosting the body's own defence system (the immune system) to destroy cancer cells more effectively. Researchers are particularly interested in whether this new three-drug combination can improve how well these medicines shrink tumours.

Over 35 people will take part in this study. The main goals are to carefully check the safety of this new combination and see if patients can tolerate it well. They also want to find the right amounts (doses) of BI-1607 and ipilimumab to use when combined with pembrolizumab. Finally, and very importantly, they want to find out if this triple treatment is more effective at fighting the melanoma compared to current usual care.

Key takeaways

This study evaluates a new three-drug combination for advanced melanoma.
It aims to find safe doses and assess effectiveness for patients whose cancer worsened on previous treatment.
The new drug, BI-1607, is hoped to boost the immune system's fight against cancer.
Participants must have melanoma that has spread or can't be surgically removed.
The study involves regular check-ups, blood tests, and scans.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for around 35 adults aged 18 or older who have advanced melanoma that has spread or cannot be removed by surgery. To join, your melanoma must have gotten worse even after you've been treated with a type of medicine called an anti-PD-1/L1 drug. If you have a specific type of melanoma called uveal melanoma, you might be able to join without having had previous anti-PD-1/L1 treatment.

You also need to be generally well enough to take part, with good overall health and organ function, as shown by various medical tests. Before joining, you will need to agree to provide tissue samples (biopsies) from your tumour for the researchers to study. You should also have at least 12 weeks of life expectancy and be able to move around and carry out daily activities with little or no difficulty.

There are also specific medical requirements regarding previous treatments, particularly for melanoma, and certain blood test results will need to be within a healthy range. If you have a history of hepatitis B or C, there are also specific conditions you'd need to meet regarding your viral levels.

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 spread or can't be removed by surgery?
Has your melanoma gotten worse after treatment with a specific type of immunotherapy (anti-PD-1/L1)?
Are you generally well enough to take part and have good organ function?
Are you willing and able to provide tumour samples (biopsies)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the investigational drug BI-1607 along with pembrolizumab and ipilimumab. The research team will regularly check your health and how you respond to the treatment. This will involve physical examinations, blood tests, and scans to monitor your tumour. They'll also carefully watch for any side effects you might experience.

The study will involve several visits to the clinic for treatments and check-ups. The doctors will also look at how the drugs act in your body and if they have the expected effects on your immune system. You may also need to consider your ability to provide tumour biopsies during the study period, although exceptions can be made in some medical circumstances.

The total length of time you'll be involved in the study will depend on how you respond to the treatment and the study's design. This includes the treatment period itself and a follow-up period to continue monitoring your health, even after you stop taking the study drugs.

Potential risks and benefits

Participating in research studies carries both potential benefits and risks. You might benefit from a new treatment that could help your melanoma, especially if standard treatments haven't worked. However, there's no guarantee the treatment will be effective for you. You might also experience side effects from the new drug combination, some of which could be serious or unexpected. The research team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Charité - Universitatsmedizin Berlin
Verified postcode
Berlin, Germany
University Hospital Essen
Verified postcode
Essen, Germany
University Hospital Heidelberg
Verified postcode
Heidelberg, Germany
University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg and Clinical Cooperation Unit Dermato-Oncology(G300) German Cancer Research Center(DKFZ)
Verified postcode
Mannheim, Germany
Hospital Universitario Vall d'Hebron
Verified postcode
Barcelona, Spain
University Hospital 12 de Octubre
Verified postcode
Madrid, Spain
Sarah Cannon Research Institute UK
Verified postcode
London, United Kingdom
Velindre Cancer Centre
Verified postcode
Cardiff, United Kingdom
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in the cells that give your skin its colour. It can sometimes spread to other parts of the body.

What is BI-1607?

BI-1607 is a new drug being tested in this study. It's designed to work with existing melanoma treatments to help your body's immune system fight the cancer better.

Why are they combining three drugs?

Researchers hope that by combining BI-1607 with two currently used drugs (pembrolizumab and ipilimumab), they can create a more powerful treatment that is more effective against melanoma.

What are the main goals of this study?

The main goals are to find out if the new three-drug combination is safe, to figure out the best doses of the drugs, and to see if it helps shrink melanoma tumours.

Will I have to have biopsies?

Generally, yes. You will need to be willing to provide tumour samples (biopsies) at certain times during the study, unless there's a medical reason you can't.