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

A Phase 1/2 Study of BMS-986408 Alone and in Combination with Nivolumab or with Nivolumab and Ipilimumab in Participants with Advanced Solid Tumors

This research is looking at a new medicine called BMS-986408, both by itself and when given together with other cancer treatments, nivolumab and ipilimumab. The study is for people with advanced solid tumours, which are cancers that have grown or spread. This is a very early-stage study, meaning it's one of the first times this new drug is being tested in people. The main goals are to find out how safe the new drug is, what side effects people might experience, and at what point the side effects become too much. Researchers will also look at how the body handles the drug and if it helps to shrink tumours or stop them from growing. This information will help them decide if the drug should be studied further.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Bristol-Myers Squibb International Corporation, Bristol-Myers Squibb International Corporation

Enrolment target

Start

24 May 2023

Advanced Solid Tumours

What is this study about?

This clinical trial is designed to understand more about an investigational new drug, BMS-986408. When a drug is called 'investigational,' it means it's still being studied and is not yet approved for general use. The study is particularly looking at its effects on advanced solid tumours. Solid tumours are growths of abnormal cells in organs like the breast, lung, or bowel. 'Advanced' means the cancer may have grown larger or spread to other parts of the body.

In this study, researchers are testing BMS-986408 in a few different ways: by itself, and then in combination with two existing cancer medicines called nivolumab (brand name OPDIVO) and ipilimumab. Nivolumab and ipilimumab are types of immunotherapy, which work by helping your body's immune system fight cancer. The main purpose of this early phase (Phase 1/2) is to carefully check the safety of BMS-986408, both alone and with these other drugs, and to see what dose is safe to give. They will be very carefully monitoring for any unwanted effects or reactions to the medication.

Beyond safety, the study will also look at how your body processes BMS-986408. This includes checking how much of the drug gets into your system and how long it stays there. The researchers will also be observing whether the treatments have any effect on the tumours, such as making them shrink or stopping them from growing. This information is crucial for deciding if this new drug has the potential to be a useful future treatment for people with these types of cancers.

Key takeaways

This study is for people with advanced solid tumours.
It's testing a new drug (BMS-986408), alone and with existing immunotherapy drugs.
The main goals are to check safety, side effects, and how the body handles the new drug.
Researchers will also look for signs that the treatment is affecting the cancer.
Participation involves regular clinic visits for treatments and checks.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. Both men and women can join.

The research team will have a more detailed list of requirements. These might include things like your specific type of advanced solid tumour, how well your other organs (like your liver and kidneys) are working, and what other medical conditions you might have. They will also need to review any previous cancer treatments you've had.

It's important to understand that these rules are in place for your safety and to ensure the study results are clear. Even if you meet the age and sex criteria, there may be other reasons why you wouldn't be able to join. The study doctor will discuss all the specific details with 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 an advanced solid tumour?
Are you able to travel to the study clinic for regular appointments?
Are you willing to undergo regular medical tests and scans?
Are you happy to try a new, investigational medicine?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments. You would receive the study medication (BMS-986408, and possibly nivolumab and/or ipilimumab) as infusions, which are given into a vein. During your visits, the research team will perform various tests, such as blood samples, physical examinations, and scans (like CT or MRI scans) to monitor your health, check for side effects, and see how your tumour is responding. You would have frequent appointments at the beginning, which may become less often over time if you continue to benefit from the treatment.

The total duration of your participation would depend on how your body responds to the treatment and if you experience any side effects. You would continue receiving the study treatment for as long as it is working for you and you are tolerating it well. After stopping the study treatment, you would likely have follow-up visits or phone calls for a certain period to monitor your long-term health.

All medications directly related to the study would be provided free of charge, but you would need to arrange travel to the study clinic for your appointments.

Potential risks and benefits

There are potential benefits to taking part in this study, such as receiving a new investigational treatment that might help your advanced solid tumour. You would also be closely monitored by a team of medical professionals, which can be reassuring. However, like all medicines, the study drugs may cause side effects, some of which could be serious or unexpected. These might include common side effects associated with cancer treatments or new side effects from the investigational drug. The full list of potential risks will be discussed in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

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

—
Unverified
France
—
Unverified
Spain

Common questions

What is an advanced solid tumour?

An advanced solid tumour is a cancer that has grown large or spread to other parts of the body from where it started. Examples include cancers of the lung, breast, or bowel.

What does 'Phase 1/2' mean?

This means it's an early-stage study. Phase 1 focuses mainly on finding a safe dose and checking for side effects. Phase 2 then looks at how well the drug works against the cancer, while still monitoring safety.

What is BMS-986408?

BMS-986408 is a new drug that is still being tested. We don't yet know if it's safe or effective. This study aims to find this out.

What are nivolumab and ipilimumab?

These are already approved cancer drugs (immunotherapies) that help your body's own immune system find and fight cancer cells. They are sometimes used in combination with new drugs.

Will I definitely get the new drug?

Yes, everyone in this study will receive the investigational drug BMS-986408, either by itself or in combination with nivolumab or nivolumab and ipilimumab.