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

A Phase 1b/2 Study of BMS-986442 in Combination with Nivolumab or Nivolumab and Chemotherapies in Participants with Advanced Solid Tumors and Non-small Cell Lung Cancer

This research study is for adults with advanced solid tumours, including a specific type of lung cancer called non-small cell lung cancer. It's testing a new drug called BMS-986442. This new drug is given alongside other established cancer treatments like nivolumab (Opdivo) and different types of chemotherapy (such as docetaxel, paclitaxel, carboplatin, and pemetrexed). The main aims of the study are to understand if these combinations are safe and what side effects they might cause. Researchers will also look at how much of the new drug stays in the body and if the treatments help to shrink tumours or slow down their growth. This is an early-stage study, meaning it's one of the first times these drug combinations are being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Bristol-Myers Squibb Services Unlimited Company, Bristol-Myers Squibb Services Unlimited Company

Enrolment target

106

Start

19 Jul 2023

Solid Tumor Non-small cell lung cancer

What is this study about?

This study is an important step in developing new treatments for advanced solid tumours, which include many different types of cancer, and a specific type of lung cancer called non-small cell lung cancer. Doctors are researching a new drug, BMS-986442, in combination with treatments that are already used for cancer. The main goal is to see if these new combinations are safe and what effects they have on patients.

Researchers will be looking closely at any side effects people experience when taking these drugs together. They also want to understand how the new drug behaves in the body, such as how long it stays there. Importantly, they will be checking if these combinations help to slow down cancer growth or shrink tumours. This involves monitoring how the cancer responds to the treatment over several months.

This is an early-stage clinical trial, called a Phase 1b/2 study. This means it's one of the first times this new drug combination is being tested in people, building on earlier lab research. The initial part focuses heavily on safety and finding the right dose, while the later part also looks at how effective the treatment is. Taking part could help improve future cancer treatments for other patients, even if it doesn't directly benefit everyone in the study.

Key takeaways

This study tests a new drug (BMS-986442) for advanced solid tumours and a type of lung cancer.
It combines the new drug with existing cancer treatments like nivolumab and chemotherapy.
The main aims are to check for safety and find out how effective the drug combinations are.
All participants must be at least 18 years old.
Taking part could lead to new treatments for future patients.
You can withdraw from the study at any point without affecting your care.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

The main requirement is that you have a diagnosis of an advanced solid tumour or non-small cell lung cancer that is no longer responding well to standard treatments or for which no other effective treatments are available.

There will be other detailed criteria that your doctor will need to check to make sure the study is a safe and suitable option for you. These might include your general health, how well your organs are working, and what other treatments you've had in the past.

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 or non-small cell lung cancer?
Have you discussed this trial with your specialist doctor?
Are you able to attend regular hospital visits for treatment and monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular hospital visits for assessments and treatments. These visits will involve blood tests, physical examinations, and scans (like CT or MRI) to check on your health and how your cancer is responding. You will receive the study drugs, which could be BMS-986442 alongside nivolumab (Opdivo) or nivolumab with chemotherapy drugs. The exact schedule for your visits and treatments will be explained to you in detail.

After your treatment period, there will be a follow-up phase where doctors will continue to monitor your health and the long-term effects of the treatment. The total duration of your participation, including follow-up, will depend on how your treatment progresses and will be clearly communicated by the study team.

Potential risks and benefits

Potential benefits of joining this study include gaining access to a new treatment that isn't yet available outside of clinical trials, which might help control your cancer. However, this is not guaranteed, and the main goal is to gather information to help future patients. Like all medicines, the study drugs may cause side effects, some of which could be serious. The study team will monitor you very closely for any side effects and will explain all known risks to you. You have the right to withdraw from 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
Italy
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Unverified
Poland

Common questions

What is a 'solid tumour'?

A solid tumour is a growth of abnormal cells that forms a mass, as opposed to cancers in blood cells like leukaemia.

What is 'advanced' cancer?

Advanced cancer means the cancer has spread from where it started to other parts of the body, or it has returned after treatment.

What is 'chemotherapy'?

Chemotherapy uses powerful drugs to kill cancer cells or stop them from growing.

What is 'nivolumab' (Opdivo)?

Nivolumab is a type of immunotherapy that helps your body’s immune system fight cancer cells.

What does 'Phase 1b/2' mean?

It means this is an early stage study. Phase 1b focuses on safety and finding the right dose, and Phase 2 looks at how well the treatment works.