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

A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

This research study is investigating a new treatment for advanced cancers. It's called a 'Phase 1/2a' study, meaning it's an early step to understand how a new drug, BMS-986016, works in people. We are testing this new drug both by itself and in combination with an existing cancer medicine called Nivolumab. The main goals are to find out how safe these treatments are, whether they have any side effects, and if they can help shrink or control the cancer. This early stage of research is crucial for developing new and better ways to treat cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

1,003

Start

21 Feb 2024

Neoplasms by site

What is this study about?

This study is designed to learn more about a new treatment for advanced cancers. When cancer is 'advanced', it means it has spread from where it started. The new treatment involves a drug called BMS-986016, which is a type of medicine known as an 'anti-LAG-3 monoclonal antibody'. This drug works by targeting specific parts of your immune system, hoping to help it fight the cancer. We are also looking at how this new drug works when given alongside an existing cancer medicine called Nivolumab (also known as OPDIVO), which is an 'anti-PD-1 monoclonal antibody' and is already used to treat certain cancers.

This is an early-stage study, sometimes called a Phase 1/2a trial. This means it's one of the first times this new drug is being tested in people. The main aim is to understand how safe the new drug is, whether it causes any side effects, and if combining it with Nivolumab changes these effects. We also want to see if these treatments can help to slow down or stop the cancer from growing.

The information gathered from this study will be used to decide if these treatments are promising enough to be studied in larger groups of people, eventually leading to new treatment options for patients with advanced cancers. It’s an important step in bringing potentially life-changing medicines to those who need them.

Key takeaways

This is an early study for advanced cancers.
It tests a new drug (BMS-986016) alone and with an existing drug (Nivolumab).
The main goals are to check safety and if the treatments help fight cancer.
Participation involves regular visits and health checks.
There are potential risks and benefits, and you can withdraw at any time.
Results from this study will help develop future cancer treatments.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. Both men and women can take part.

This study is for people who have advanced cancer. 'Advanced cancer' means the cancer has spread beyond its original site and might not be responding well to standard treatments.

There will be other detailed medical checks to make sure the study is safe for you and that you meet all the requirements. For example, your general health, how well your organs are working, and your past medical history will all be carefully reviewed by the study doctors.

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 advanced solid cancer?
Are you generally well enough to take part in a clinical study?
Are you willing to attend regular hospital/clinic visits and undergo tests?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study medication, either BMS-986016 alone, or in combination with Nivolumab, given through a drip (infusion).

To check your health and how the treatment is working, you would have various tests. These include blood tests, urine tests, and possibly scans or other examinations. You'll also be asked about any side effects you experience.

The study would involve regular follow-up appointments even after you finish the main treatment period, to monitor your health and any long-term effects. The total duration of your participation, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

While we hope this study will help us understand more about fighting cancer, there are potential benefits and risks. You might not directly benefit from taking part, but your involvement could help others in the future by increasing our knowledge of cancer treatments. As with any medicine, there's a chance of side effects, which could range from mild to serious. The study team will carefully monitor you for these and explain them in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

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

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Unverified
Finland
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Unverified
Norway
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Unverified
Denmark
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Unverified
France
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Unverified
Italy
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Unverified
Austria
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Unverified
Germany
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Unverified
Spain
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Unverified
Netherlands

Common questions

What does 'advanced solid tumors' mean?

This refers to cancers that have grown from a solid lump of cells and have spread beyond where they first started in the body.

What are 'monoclonal antibodies'?

These are special proteins made in a lab that act like your body's natural antibodies. They are designed to find and attach to specific targets, like cancer cells or parts of your immune system, to fight the disease.

What is the difference between Phase 1 and Phase 2 studies?

Phase 1 studies mainly focus on finding a safe dose and checking for side effects. Phase 2 studies look at whether the treatment works against the disease, while still monitoring safety. This study combines both stages.

Will I know if I'm getting the new drug or the existing drug?

The study team will explain exactly which treatment group you would be in as part of the informed consent process. You won't be given a 'dummy' or placebo drug in this study, as it's directly testing active cancer treatments.

What are 'Adverse Events (AEs)'?

This is a medical term for any unwanted or unexpected health problems that happen during a study, whether or not they are thought to be related to the treatment.