Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2 Study of BMS-986253 in Combination with Nivolumab or Nivolumab plus Ipilimumab in Advanced Cancers

This research study is looking into a new medicine, BMS-986253, for people with advanced solid cancers. It's being tested in combination with other anti-cancer drugs called Nivolumab and Ipilimumab. The main goals are to find out if the new medicine, when given with these others, is safe and what side effects it might cause. Doctors will also check if these combinations help slow down or shrink the cancer. This is one of the first times these specific combinations are being used in people, so it's an important step to learn more about potential new ways to treat advanced cancers. The study is open to adults aged 18 and older.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

113

Start

20 Mar 2024

Advanced solid tumors

What is this study about?

This study is a research project looking for new and better ways to treat advanced solid cancers. These are cancers that have grown or spread in the body. The study is testing a new medicine called BMS-986253. This new medicine is being given along with two anti-cancer drugs that are already used, called Nivolumab (also known as OPDIVO) and Ipilimumab. Sometimes it will be BMS-986253 plus Nivolumab, and other times it will be BMS-986253 plus both Nivolumab and Ipilimumab.

The main purpose of this study is to see how safe these combinations of medicines are for people with advanced cancers. Doctors will be carefully watching for any side effects and how serious they might be. They also want to see if the medicines help to slow down or shrink the cancer. This is an early-stage study, meaning it’s one of the first times these specific combinations are being tested in people. This type of study is crucial for understanding if a new medicine has the potential to become a helpful treatment in the future.

Researchers will also look at how much of the new medicine (BMS-986253) stays in your body over time. They will also measure a substance called IL-8 in your blood, as this might give them clues about how the medicine is working. Finally, they will track how long patients live without their cancer getting worse, to understand the potential benefits of the treatment.

Key takeaways

New medicine (BMS-986253) being tested for advanced cancers.
Combined with Nivolumab or Nivolumab plus Ipilimumab.
Main goals are to check safety and how well the combination works.
An early-stage study, open to adults aged 18 and over.
Participation involves regular clinic visits for infusions and tests.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.

Because this is a study for people with advanced solid cancers, participants will need to have a diagnosis of one of these types of cancer.

There will also be other specific medical checks and requirements before you can join, which your doctor will discuss with you. These are in place to make sure the study is safe for you and that the results are clear.

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 an advanced solid cancer?
Are you able to attend regular clinic appointments?
Are you willing to have tests like blood samples and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicines as an infusion, which means they would be given through a drip into your vein. The BMS-986253 medication is a type of antibody, and the other medicines (Nivolumab and Ipilimumab) are also infusions. You would also receive simple solutions like saline or dextrose to help with the infusions.

Throughout the study, you would have regular visits to the clinic. During these visits, doctors and nurses would perform examinations, take blood and urine samples, and ask you about how you are feeling and any side effects you might be experiencing. They would also do scans to check on your cancer.

We don't know the exact duration of the study or how long each patient will be on treatment, as this depends on how you respond and what the doctors decide is best for your care. There will also be follow-up appointments after you stop the study treatment to continue monitoring your health.

Potential risks and benefits

Like all medicines, the treatments in this study may have side effects. Because this is an early-stage study, not all side effects are known, and doctors will be carefully monitoring you. There may also be no direct benefit to you personally from taking part, but the information gained will help future patients. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Italy
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Unverified
Germany
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Unverified
Spain
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Unverified
Belgium
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Unverified
Poland
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Unverified
France

Common questions

What does 'advanced solid tumors' mean?

It means cancers that have grown or spread from where they started, excluding blood cancers.

What is the purpose of BMS-986253?

It's a new investigational medicine that doctors hope will help treat advanced cancers when given with other treatments.

What are Nivolumab and Ipilimumab?

These are existing anti-cancer medicines that use your body's immune system to fight cancer.

What is a 'Phase 1/2' study?

This means it's an early-stage study. Phase 1 focuses on safety and finding the right dose, while Phase 2 starts looking at how well the medicine works.

Will I know if I'm getting the new medicine?

Yes, all participants in this study will receive the new medicine (BMS-986253) in combination with Nivolumab or Nivolumab plus Ipilimumab.