RecruitingPHASE1INTERVENTIONAL

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

This research study is investigating a new experimental medicine called BMS-986488. It's designed for people with advanced cancers that have either spread to other parts of the body or cannot be removed through surgery. The main goals are to find out if BMS-986488 is safe to use and how well people can tolerate it. Researchers will also be checking if it shows any signs of shrinking or controlling the cancer, both when given alone and when combined with other existing cancer treatments like Adagrasib, Cetuximab, or Nivolumab. Because this is an early-stage study, it's focused on understanding these key aspects of the new treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Bristol-Myers Squibb

Enrolment target

437

Start

25 Mar 2025

Estimated completion

15 Oct 2027

Advanced Malignant Tumors

What is this study about?

This study is exploring a new medicine called BMS-986488 for people who have advanced cancer. 'Advanced cancer' means the cancer has spread from where it started (metastatic) or it's grown too much to be removed by an operation (unresectable). The aim is to see if this new drug, BMS-986488, is safe for people to take, how well they tolerate it (meaning, what side effects they might experience), and if it has any positive effects on the cancer itself.

The researchers are testing BMS-986488 in a couple of ways: sometimes on its own, and sometimes combined with other well-known cancer medications like Adagrasib, Cetuximab, or Nivolumab. The hope is that combining these medicines might be more effective. This is an early-stage study, which means it’s one of the first times this new drug is being tested in a larger group of people, so important information about its safety and potential benefits can be gathered.

Understanding how new treatments like BMS-986488 work is crucial for developing better ways to fight cancer in the future. By taking part, volunteers help doctors learn more about this experimental medicine, which could potentially lead to new treatment options for others facing similar diagnoses. It's a vital step in medical research.

Key takeaways

This study tests a new cancer drug, BMS-986488, for advanced cancers.
It aims to check the treatment's safety, side effects, and early signs of effectiveness.
BMS-986488 is given alone or with other cancer medicines.
It's for people with certain advanced cancers, including specific types like lung or bowel cancer.
Participants will have regular health checks and scans.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be aged 18 or over. You must have a diagnosis of certain types of cancer that are advanced – meaning the cancer has either spread (metastatic) or cannot be removed by surgery (locally advanced and unresectable). For specific parts of the study, they are looking for particular cancer types such as kidney cancer, ovarian cancer, lung cancer, bowel cancer, or pancreatic cancer. Some parts of the study are specifically for people whose cancer has a particular gene change called 'KRAS G12C mutation'.

Your general health also plays a role in who can join. The doctors will check your overall fitness using a scale called ECOG, and you'd need to have a score of 0 or 1, which means you're generally quite active or can carry out light work. Also, your cancer needs to be 'measurable', meaning doctors can clearly see and track its size using scans.

There are also reasons why someone might not be able to join. For example, if your cancer has spread to your brain or spinal cord in a certain way, or if you have serious heart problems. If you've previously had severe lung inflammation or serious skin reactions to medicines, you might not be eligible for certain parts of the study that involve specific drug combinations. The study team will review all your medical details carefully to see if this study is right 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 advanced cancer that has spread or can't be removed by surgery?
Are you generally quite active and able to do light daily tasks?
Can doctors clearly measure your cancer on scans?
Do you have any serious untreated brain cancer spread or specific heart problems?
Have you had severe lung inflammation or very serious skin reactions to medicines before?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the experimental medicine BMS-986488, either by itself or with other study drugs, as decided by the research team. This will involve regular visits to the clinic for medical examinations, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is affecting your cancer. These assessments help doctors understand if the treatment is working and to manage any side effects. The exact schedule of visits and duration of treatment will depend on how your body responds to the medicine and if you experience any side effects. You will be closely monitored throughout your time in the study, and there will be follow-up appointments even after treatment ends to track your long-term health. The total time you spend in the study will vary, but you will be informed about the expected duration.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new experimental treatment that is not yet widely available. While the treatment is being investigated for its effectiveness, there's no guarantee it will work for your specific cancer. Like all medicines, BMS-986488 and the other drugs used in this study can have side effects, which could be mild or, in some cases, serious. The research team will carefully monitor you for these and provide support. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

John Theurer Cancer Center at Hackensack University Medical Center
Verified postcode
Hackensack, United States· Recruiting
Local Institution - 0020
Verified postcode
Allentown, United States· Active not recruiting
The West Clinic, PLLC dba West Cancer Center
Verified postcode
Germantown, United States· Recruiting
Local Institution - 0025
Verified postcode
Dallas, United States· Withdrawn
Local Institution - 0031
Verified postcode
Brisbane, Australia· Active not recruiting
Local Institution - 0032
Verified postcode
Vancouver, Canada· Active not recruiting
Local Institution - 0015
Verified postcode
Montreal, Canada· Not yet recruiting
Local Institution - 0016
Verified postcode
Québec, Canada· Active not recruiting

Common questions

What is BMS-986488?

It's a new experimental medicine being tested in this study for people with advanced cancer.

What is an 'advanced malignant tumor'?

This means cancer that has spread to other parts of the body or cannot be removed through surgery.

Is this medicine available outside the study?

No, BMS-986488 is an experimental medicine and is only available through this research study right now.

What 'phase' is this study?

This is a Phase 1 study, which is an early stage focused on safety, side effects, and finding the right dose.

Can I choose which treatment I get?

The study team will decide whether you receive BMS-986488 alone or in combination with other medicines, based on your specific cancer and the study design.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.