A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer
This research study is for adults with a type of lung cancer called small cell lung cancer that has either returned after treatment or hasn't responded to previous therapies. We are investigating a new medicine called BMS-986525. Doctors want to understand how safe this new drug is, which means looking at the types of side effects it might cause, how often they happen, and how serious they are. They are also studying how BMS-986525 behaves in the body, both on its own and when given together with another drug called nivolumab (also known as OPDIVO). Finally, the study aims to see if BMS-986525 can help shrink the cancer or slow its growth. This is an early-stage study, meaning it's one of the first times this drug is being tested in people.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned medical research study involving people. The main goal is to test a new medicine called BMS-986525 for individuals who have small cell lung cancer. This type of lung cancer can sometimes be particularly challenging to treat, especially if it returns after initial treatment or doesn't respond well to standard options.
The researchers are keen to learn several important things about BMS-986525. Firstly, they want to understand its safety. This involves carefully monitoring participants for any side effects, noting what they are, how often they occur, and how severe they might be. This information helps doctors understand what to expect if this drug is used more widely in the future. Secondly, the study will look at how the body handles BMS-986525 – how it's absorbed, where it goes, and how it leaves the body. This is important for figuring out the best way to give the medicine.
Finally, the study also aims to see if BMS-986525 can help fight the cancer. This will be explored by giving the drug on its own to some participants, and to others, it will be given alongside an existing treatment called nivolumab (OPDIVO). By doing this, doctors can compare the effects and see if combining these treatments might be more effective against the cancer.
Key takeaways
- This study is for adults with small cell lung cancer that has come back or not responded to previous treatments.
- It's testing a new drug, BMS-986525, alone and with nivolumab.
- The main goals are to check the drug's safety and see if it helps against cancer.
- Participation involves regular clinic visits for treatments and health checks.
- It's an early-stage study, meaning the drug is still being thoroughly investigated.
Who may be eligible?
To join any clinical study, there are certain requirements that help make sure it's safe for you and that the results are clear. This particular study is for adults, meaning you must be at least 18 years old.
The most important health requirement is that you have small cell lung cancer that has either come back after past treatments or hasn't responded well to those treatments. The study is open to both men and women.
There will be other, more detailed health checks to make sure this study is the right fit for you. These will be discussed with you by the study doctor to confirm if you can safely take part.
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 small cell lung cancer?
- Has your lung cancer returned or not responded to past treatments?
- Are you able to attend regular clinic appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would receive the study drug, BMS-986525, which will be given intravenously (through a drip into your vein). Some participants will receive BMS-986525 on its own, while others will receive it in combination with nivolumab, which is also given as a drip. You will have regular visits to the clinic for treatments and check-ups.
These visits will involve various tests and assessments to see how you are feeling, to monitor any side effects, and to check how your body is responding to the treatment. These could include blood tests, scans (like CT scans), and physical exams. The doctors and nurses will explain exactly what each visit will involve.
Your participation will involve several treatment cycles, and there will be follow-up appointments after your treatment period to see how you are doing. The total length of your participation will vary depending on your individual response and what the study doctors decide is best for you, but will be explained in detail before you make any decisions.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedRomania
Common questions
What is small cell lung cancer?
It's a type of lung cancer that tends to grow and spread more quickly than other lung cancers.
What does 'relapsed/refractory' mean?
It means the cancer has either returned after being treated, or it didn't respond well to previous treatments.
Is BMS-986525 a new drug?
Yes, it's a new investigational drug being tested in people for the first time or in early stages.
What is nivolumab (OPDIVO)?
Nivolumab is an approved medicine that works with your body's immune system to fight cancer.
Will I get better if I join this study?
There's no guarantee that you will get better. The study is to find out if the new drug might help.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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