Phase 1 Study of BMS-986416 with and without Nivolumab in Solid Tumors
This study is an early-stage clinical trial (Phase 1) focused on a new investigational medicine, BMS-986416, which is being tested in people with solid tumours. Sometimes, this new medicine will be given on its own, and other times it will be given together with an existing medicine called Nivolumab. The main goal of this early study is to understand how safe the new medicine is, how it behaves in the body, and what doses might be suitable. It's not about finding a cure at this stage, but rather gathering important information to see if it's safe to continue testing in larger groups of people. People aged 18 and over, of any sex, are being considered for this trial.
At a glance
What is this study about?
This clinical trial is like a first step in testing a brand new medicine, BMS-986416, for people who have been diagnosed with solid tumours. Solid tumours are types of cancer that form a lump, for example, in the breast, lung, or bowel. This study is called a 'Phase 1' study, which means it's one of the very first times doctors are giving this new medicine to people. The main aim is to carefully check if the medicine is safe and to understand how the body handles it.
Sometimes, the new medicine BMS-986416 will be given by itself. Other times, it will be given along with another medicine that is already used to treat some cancers, called Nivolumab. Doctors want to see how these medicines work together and if combining them changes how safe they are or how the body reacts to them. This kind of study helps researchers learn important information about side effects and what dose of the medicine might be best.
It's important to remember that because this is a very early study, we don't know yet if this new medicine will actually help treat cancer. The purpose is to gather crucial information so that if it looks promising and safe, it can be tested in more detail in future studies with many more people. This careful, step-by-step approach is how new medicines are developed and approved.
Key takeaways
- This is an early-stage (Phase 1) study for a new medicine, BMS-986416, for solid tumours.
- It aims to find out how safe the new medicine is and how it works in the body.
- Some participants will also receive an existing cancer medicine called Nivolumab.
- Open to adults aged 18 and over, of any sex, with a solid tumour.
- Participants will have regular clinic visits for tests and monitoring.
- You can withdraw from the study at any time without affecting your normal care.
Who may be eligible?
To be considered for this study, you would need to be at least 18 years old. There's no upper age limit mentioned.
The study is open to both men and women. You would need to have been diagnosed with a solid tumour. Beyond these general points, there would be many other detailed medical requirements that a doctor involved in the study would need to check to see if this particular trial is right for you. These might include your overall health, other medical conditions you have, and treatments you've had in the past.
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 a solid tumour?
- Are you able to attend regular hospital/clinic appointments?
- Do you understand that this is an early-stage study, and the main goal is to check safety?
What does participation involve?
If you decide to take part in this study, you would first have a number of checks to make sure the study is suitable for you. This might involve blood tests, scans, and other medical examinations. Once you are enrolled, you would receive the study medication, either BMS-986416 alone or with Nivolumab, likely through an infusion (into a vein) or by mouth, depending on the drug type.
You would have regular visits to the hospital or clinic for further tests, such as blood samples to check how the medicine is working and how your body is reacting, and to monitor for any side effects. You would also have scans to see how your tumour is responding. The number of visits and the types of tests would vary, but you should expect frequent appointments in the initial stages. After the treatment period, there would be a follow-up period where you would continue to be monitored for your health and any lasting effects. The total length of your participation would depend on your individual response and the study plan, but Phase 1 studies can involve several months of active treatment and follow-up.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
What is a 'solid tumour'?
A solid tumour is an abnormal mass of tissue that doesn't contain cysts or liquid areas. Common examples include cancers of the breast, lung, prostate, and colon.
What does a 'Phase 1' study mean?
A Phase 1 study is the first stage of testing a new medicine in people. Its main goal is to check how safe the medicine is at different doses and how the body handles it, rather than to see if it cures a disease.
What is Nivolumab?
Nivolumab is an existing medicine, already approved for some cancers. It works by helping your body's immune system fight cancer cells.
Will this study cure my cancer?
In a Phase 1 study, the main goal is to learn about safety and correct dosage. While some people might see a benefit, this study is not designed to find a cure. It's an early step in developing new treatments.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, without needing to explain why. This will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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