Integrated PK/efficacy, safety, and immunogenicity study to demonstrate similarity of JPB898, a proposed biosimilar to nivolumab, to Opdivo® in combination with Yervoy®
This study is looking at a new medicine called JPB898. It's being compared to a well-known cancer drug called Opdivo. The study wants to see if JPB898 is similar enough to Opdivo in how it works, its safety, and how the body reacts to it. Both JPB898 and Opdivo are given alongside another drug called Yervoy. This combination treatment is for people with advanced melanoma, which is a type of skin cancer that has spread or can't be removed by surgery. This is a Phase III study, meaning it's a large, important trial to confirm if the new medicine is effective and safe before it might be made available to more people. The main goal is to find out if JPB898 could be another option for treating this condition.
At a glance
What is this study about?
This clinical trial is about a new medicine called JPB898, which is being tested for people with a serious type of skin cancer called advanced melanoma. This is melanoma that has spread to other parts of the body or cannot be taken out with surgery. The trial wants to see if JPB898 works in a very similar way to an existing, approved cancer drug called Opdivo. Both of these medicines will be given together with another drug called Yervoy.
The main idea behind this study is to show that JPB898 is a 'biosimilar' to Opdivo. This means it's a very close copy of an existing biological medicine. If JPB898 proves to be similar enough in how the body handles it, how well it works, and its safety, it could become another treatment option for patients. Having more options can sometimes mean more choices for patients and potentially more accessible treatments.
This is a Phase III study, which means it's a big, important step in testing a new medicine. It involves a larger group of people to thoroughly check the new medicine's effectiveness and safety, comparing it directly to the established treatment. The information gathered will help determine if JPB898 can eventually be approved for use in treating advanced melanoma.
Key takeaways
- This study tests a new drug (JPB898) for advanced melanoma.
- It aims to show the new drug is similar to an existing treatment (Opdivo).
- Both drugs are given with Yervoy.
- It's a large study to confirm effectiveness and safety (Phase III).
- Participation involves regular clinic visits and health checks.
- You can leave the study at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Critically, you must have advanced melanoma. This means your melanoma has spread to other parts of your body (called metastatic) or it's in a place that surgeons can't remove (called unresectable). The study will have other specific rules about your overall health, any other medical conditions you have, and if you've had certain treatments before. These details are really important to make sure the study is as safe and helpful as possible for everyone involved.
It's very important to talk to your doctor or the study team to see if you meet all the requirements. They will check your medical history and do some tests to make sure the study is a good fit for you.
- Are you 18 years old or older?
- Do you have advanced melanoma (melanoma that has spread or cannot be surgically removed)?
- Are you willing to attend regular clinic appointments and have medical tests?
- Are you able to understand and agree to the study requirements?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would receive the new medication JPB898 (which is being compared to Opdivo) along with Yervoy. These are given as infusions, meaning they are slowly put into your vein, usually in your arm. You would need to attend regular appointments at the study clinic to receive your medication and have various health checks. These checks would include physical exams, blood tests, and scans to monitor your health and how the treatment is working.
The study would involve a treatment period, where you receive the medicines, followed by a period where your health is still monitored even after you stop taking the study drugs. The total time you would be involved in the study, from your first visit to your last follow-up, could be quite long – usually several months or even a few years, depending on the study's design and your individual response. The study team will explain the exact schedule and duration to you before you agree to take part.
Potential risks and benefits
Locations (11)
- —Bulgaria
- —Italy
- —Hungary
- —Lithuania
- —Germany
- —Spain
- —Czechia
- —Greece
- —Portugal
- —Romania
- —Poland
Common questions
What is advanced melanoma?
Advanced melanoma is a serious type of skin cancer that has grown and spread to other parts of your body, or it's in a place that doctors cannot remove surgically.
What is a 'biosimilar' drug?
A biosimilar drug is a medicine that is very similar to an existing, approved biological medicine. It's meant to work in the same way and be just as safe.
What does Phase III mean for a study?
Phase III is a large and important stage in testing a new medicine. It compares the new drug to an existing treatment to confirm its effectiveness and safety in many people.
Will I get the new drug or the existing drug?
In this study, you would receive the new drug, JPB898, along with Yervoy. The aim is to see if JPB898 is similar to Opdivo.
How long will I be in the study if I join?
The total time you would be involved, including treatment and follow-up, could range from several months to a few years. The study team will give you a detailed timeline.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.