Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

This study is looking into a new medicine called BMS-986288. It's being tested by itself and in combination with an existing cancer treatment called nivolumab (Opdivo). The study is for adults with different types of advanced cancers, including head and neck, lung, skin, breast, kidney, bladder, stomach, oesophageal, cervical, and bowel cancers. This is a very early-stage study, meaning it's one of the first times this new medicine is being given to people. Researchers want to understand its safety, any side effects it might cause, and how the body handles it. They will also look at how effective it is at shrinking or slowing down the cancer's growth.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

Start

16 Jan 2024

Advanced solid tumors (squamous cell carcinoma of the head and neck (SCCHN)non-small cell lung cancer (NSCLC)cutaneous melanoma triple-negative breast cancer (TNBC)renal cell carcinoma (RCC)urothelial carcinoma gastric esophageal cervical and colorectal cancer (CRC)).

What is this study about?

This study is about exploring a new cancer medicine, BMS-986288. It's an early-stage clinical trial, which means it's one of the first times this new medicine is being tested in humans. The main purpose is to see if it's safe to use, what side effects it might cause, and to find the right amount (dose) to give. Researchers will also be combining it with an existing cancer drug called nivolumab, which is already used to treat some cancers.

The study involves people with various types of advanced cancers, such as certain head and neck cancers, lung cancer, skin cancer (melanoma), a specific type of breast cancer (triple-negative), kidney, bladder, stomach, oesophageal, cervical, and bowel cancers. This wide range of cancers allows the researchers to see how the new medicine might work across different disease types.

Primarily, the team will be closely monitoring participants for any health problems or side effects that occur. They will also measure how the new medicine moves through the body. In later parts of the study, they will look at how many people's cancers shrink or stop growing, and how long these effects last. This helps them understand if the new treatment has a positive effect on the cancer.

Key takeaways

This study is testing a brand-new cancer medicine, BMS-986288.
It's for adults with various advanced cancers.
The medicine is given alone or with an existing drug called nivolumab.
The main goals are to check for safety, side effects, and how well it works.
This is an early-stage study, so new information is still being gathered.
Participants will have regular check-ups and monitoring.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. The study is open to both men and women.

You must have an advanced form of cancer, which means it has spread or cannot be removed by surgery. The specific types of cancer being studied include certain head and neck cancers, lung cancer, melanoma, triple-negative breast cancer, kidney cancer, bladder cancer, stomach cancer, oesophageal cancer, cervical cancer, and bowel cancer. Your doctor will confirm if your specific cancer type and stage fit the study criteria.

There might be other health requirements and conditions that would mean you can or cannot join. For example, your overall health and any other medical problems you have would be carefully considered by the study doctors. They will explain all the specific rules.

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 advanced cancer that has spread or cannot be treated with surgery?
Is your cancer type one of those listed (e.g., head/neck, lung, melanoma, breast, kidney, bladder, stomach, oesophageal, cervical, bowel cancer)?
Are you able to travel to regular hospital or clinic appointments?
Are you generally well enough to take part in a study like this?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. During these visits, you will undergo various tests, such as blood tests, scans (like CT or MRI), and physical examinations to check your health and how the treatment is working. You will also receive either the new medicine (BMS-986288) on its own, or in combination with nivolumab. The nivolumab is given as a drip into your arm.

The study also includes taking another medicine called Regorafenib (Stivarga) in tablet form, which is used in some parts of the study. You will be closely monitored for any side effects throughout your participation. The study duration will vary for each person, depending on how their cancer responds and if they experience any side effects. After treatment, there will likely be follow-up appointments to continue monitoring your health.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new experimental medicine that is not yet widely available. This new treatment could potentially help shrink your cancer or slow its growth. However, there are also potential risks involved. These medicines can cause side effects, some of which might be severe or unexpected. The study team will explain all known side effects and monitor you closely. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Italy

Common questions

What is the new medicine (BMS-986288) supposed to do?

It's a new experimental cancer drug. Researchers hope it might help to fight different types of advanced cancers, either on its own or with nivolumab.

What is nivolumab and why is it used?

Nivolumab (Opdivo) is an existing cancer treatment that helps your body's immune system fight cancer. It's being used in this study to see if it works better when combined with the new medicine.

What does 'advanced malignant tumors' mean?

This means cancers that have grown or spread to other parts of the body, and typically cannot be cured with surgery alone. The study lists specific types of these cancers.

Why is this a 'first-in-human' study?

This means it's one of the first times this particular new medicine (BMS-986288) is being given to people. The main focus at this stage is usually on safety and finding the right dose.

Will I know if I'm getting the new medicine or something else?

In this type of study, you'll be receiving the new medicine, either alone or with nivolumab. There isn't a placebo group (where some people get a dummy treatment).