Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors

This research study is looking at a new medicine called BMS-986360/CC-90001. It's for adults with advanced solid cancers, which are cancers that have grown or spread. The study wants to find out if this new medicine is safe and what doses can be given. Researchers will give the medicine on its own to some patients, and to others, they will give it along with standard cancer treatments like chemotherapy or another medicine called nivolumab. This is an early phase study, which means it's one of the first times this new medicine is being tested in people. This helps doctors learn important information about how the medicine works and if it might be a helpful future treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Celgene Corp.

Enrolment target

Start

11 Jul 2023

Solid Tumor

What is this study about?

This study is exploring a new potential cancer treatment called BMS-986360/CC-90001. If you have been diagnosed with an advanced solid tumour, which is a cancer that has grown or spread in your body, this study might be relevant to you. The main goal is to understand how safe this new medicine is and to find the best dose to give people.

Researchers will be giving the new medicine in different ways. Some patients will receive BMS-986360/CC-90001 by itself, while others will receive it in combination with other common cancer treatments. These could include chemotherapy, which uses strong drugs to kill cancer cells, or nivolumab, which is a type of immunotherapy that helps your body's immune system fight cancer.

Because this is an early-stage (Phase 1) study, it means that this medicine is still very new. Doctors are still learning a lot about it. Studies like this are really important for developing new ways to treat cancer in the future. They help doctors understand what effect the medicine has on the body and whether it could potentially help people with cancer.

Key takeaways

This study is testing a new cancer medicine called BMS-986360/CC-90001.
It's for adults with advanced solid tumours (cancers that have grown or spread).
The main aims are to check the medicine's safety and find the right dose.
The new medicine will be given alone or with common cancer treatments like chemo or nivolumab.
This is an early-stage study, meaning the medicine is still very new.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult, aged 18 or over. This study welcomes both men and women.

You would need to have an advanced solid tumour. This means your cancer is one that affects organs like your breast, lung, bowel, or prostate, and it has either grown or spread to other parts of your body.

There may be other specific health requirements or conditions that would mean you can or cannot join the study. These could include details about your past treatments, any other health problems you have, or specific blood test results. Your doctor would check all these details carefully to see if this study is suitable for you.

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 a diagnosis of an advanced solid tumour?
Are you able to travel to a study clinic for regular appointments?
Are you comfortable understanding that this is an early-stage, experimental treatment?

Answer every question to see your result.

What does participation involve?

If you decide to join, you would receive the study medicine, BMS-986360/CC-90001, either on its own or with other cancer treatments. The study team will explain exactly how the medicine is given and how often. You'll have regular visits to the clinic, where doctors and nurses will check your health, take blood and urine samples, and ask you about any side effects you might be experiencing. These checks are important to make sure the treatment is safe for you.

The total amount of time you would be in the study will vary for each person. You might continue receiving the study treatment for as long as it is helping you and you are not experiencing significant side effects. After you stop treatment, there would likely be a follow-up period where the study team would check in on your health.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that you might be among the first to receive a new medicine that could help treat your cancer. However, because this is a new medicine, there is no guarantee it will work for you, and it might not improve your condition. Potential risks include experiencing side effects from the study medicine, which could be mild or serious. The research team will carefully monitor you for any side effects and will explain all known risks before you decide to join. Remember, you can always choose to 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
Italy
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Unverified
Spain
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Unverified
France

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Examples include cancers of the breast, lung, bowel, and prostate. It's different from blood cancers like leukaemia.

What does 'advanced' cancer mean?

Advanced cancer means that the cancer has either grown larger in its original location or has spread to other parts of your body. It doesn't mean that there's no hope for treatment.

What is 'Phase 1' study?

A Phase 1 study is the first step in testing a new medicine in people. It primarily aims to find out if the medicine is safe, how it behaves in the body, and what dose can be given without causing too many problems.

What is chemotherapy?

Chemotherapy is a type of cancer treatment that uses powerful drugs to kill fast-growing cells in the body, including cancer cells. It can be given in different ways, like through a drip into your vein or as tablets.

What is nivolumab?

Nivolumab is a type of immunotherapy. This medicine helps your body's own immune system to recognise and fight cancer cells more effectively. It encourages your immune system to attack the cancer.