Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

This research study is investigating an experimental drug called BMS-986449. It's being tested alone and in combination with another approved cancer drug, nivolumab, in people with advanced solid tumours. The main goals are to check how safe these treatments are and how well they work against cancer. This is a Phase 1/Phase 2 study, meaning it's still in relatively early stages of testing in humans, focusing on finding the right dose and gathering initial information about its effectiveness. It's designed for patients whose cancers are advanced and haven't responded to or cannot receive standard treatments. The study aims to gather important information to potentially develop new treatment options for these types of cancers.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

100

Start

06 Jun 2023

Estimated completion

30 Sep 2026

Advanced Solid Tumors

What is this study about?

This study is looking into new ways to treat advanced solid tumours. 'Solid tumours' refer to cancers that form a lump, like lung cancer or breast cancer, rather than blood cancers. 'Advanced' means the cancer has grown or spread and is harder to treat with standard methods.

The main focus is on a new experimental drug called BMS-986449. Researchers are giving this drug to some patients on its own, and to others, they are giving it along with an existing cancer drug called nivolumab. Nivolumab is an immunotherapy drug that helps your body's immune system fight cancer. By combining these, the hope is to find a more powerful treatment approach.

The purpose of this research is to see if these treatments are safe for people and how well they can shrink or control cancer. This type of study, called a Phase 1/Phase 2 trial, helps scientists learn important information about new drugs, including suitable doses and early signs of their effectiveness, before they can be widely used. It's an important step in developing new medicines for serious illnesses.

Key takeaways

Investigating a new drug (BMS-986449) for advanced solid tumours.
Testing the new drug alone and with nivolumab (an immunotherapy).
Targets advanced cancers that haven't responded to standard treatments.
Focuses on safety and early signs of effectiveness.
Specific parts are open to non-small cell lung cancer and triple-negative breast cancer patients.
Participation involves regular clinic visits, treatments, and monitoring.

Who may be eligible?

To join this study, you generally need to be an adult (18 or older) with an advanced solid cancer that has been confirmed by a doctor. Your cancer should not have responded well to, or you can't have, the usual treatments available.

Initially, the study is open to people with any type of advanced solid cancer. However, specific parts of the study will only accept people with advanced non-small cell lung cancer (NSCLC) or advanced triple-negative breast cancer (TNBC).

You won't be able to join if you've had certain serious side effects from previous immunotherapy drugs (like some T-cell treatments). Also, if you have current or recent severe stomach or bowel problems or surgery that might affect how your body absorbs the study drug, you might not be eligible. Your study doctor will review all your health information to make sure joining is safe 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 doctor-confirmed advanced solid cancer?
Has your cancer not responded to, or can you not receive, standard treatments?
If you have non-small cell lung cancer or triple-negative breast cancer, you might be eligible for specific parts.
Have you *not* had severe side effects from previous immunotherapy (e.g., anti-PD-1/PD-L1) that might re-occur?
Do you *not* have severe stomach or bowel issues that could interfere with taking study medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new drug BMS-986449 on its own or a combination of BMS-986449 and nivolumab. The exact schedule will vary, but you will have regular visits to the clinic for treatments, check-ups, and tests like blood samples and scans to monitor your health and how the treatment is working. A small sample of your tumour (a biopsy) will also be needed before you start, unless your doctor says it's not possible.

The total duration of your participation will depend on how you respond to the treatment and what the study doctors think is best for you. You will be closely monitored throughout the study and for a period afterwards. All aspects of your participation will be explained in detail by the study team, and you'll have plenty of opportunities to ask questions.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new, experimental treatments that are not yet widely available. However, there are also potential risks involved. New drugs can have side effects, some of which may be serious, and the treatment might not work for everyone. The study team will closely monitor your health for any side effects and provide care. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (20)

Local Institution - 0021
Verified postcode
Los Angeles, United States
Local Institution - 0007
Verified postcode
New Haven, United States
Local Institution - 0010
Verified postcode
Hackensack, United States
Local Institution - 0022
Verified postcode
Lake Success, United States
Local Institution - 0016
Verified postcode
Brussels, Belgium
Local Institution - 0017
Verified postcode
Ghent, Belgium
Local Institution - 0002
Verified postcode
Villejuif, France
Local Institution - 0004
Verified postcode
Marseille, France
Local Institution - 0003
Verified postcode
Bordeaux, France
Local Institution - 0023
Verified postcode
Rozzano, Italy
Local Institution - 0024
Verified postcode
Siena, Italy
Local Institution - 0026
Verified postcode
Bergamo, Italy

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumours, which means cancers that form a mass (like lung or breast cancer) that have grown or spread. Specific parts of the study focus on non-small cell lung cancer and triple-negative breast cancer.

What are the drugs being tested?

The study is testing a new experimental drug called BMS-986449, both alone and in combination with an existing cancer drug called nivolumab. Nivolumab is an immunotherapy that helps your immune system fight cancer.

What does 'Phase 1/Phase 2' mean?

These phases mean it's an early-stage study in humans. Phase 1 primarily checks the safety and finds the right dose, while Phase 2 gathers more information on effectiveness and continues to monitor safety.

Will I definitely get the new drug?

If you are eligible and choose to participate, you will receive either BMS-986449 on its own or the combination of BMS-986449 and nivolumab. This is not a placebo-controlled trial, meaning everyone receives active treatment.

Do I have to stop my current cancer treatment to join?

This study is for people whose cancer has not responded to or cannot receive existing treatments. Your doctor will discuss your specific situation and if it's appropriate to pause or stop other treatments to join the study.