Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

CA209-8KX Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy

This research study, called CA209-8KX, is exploring a new way to deliver a cancer drug called nivolumab. Currently, nivolumab is often given through a drip into a vein. This study is testing a new version of the medicine that can be given as an injection under the skin, which might be more convenient. This is an early-stage study (Phase I and II) looking at how the body absorbs and uses the medicine, and also checking for any side effects. It's open to adults with advanced lung, kidney, melanoma, liver, colorectal (bowel), or bladder cancer. The main goal is to understand how much medicine is in the blood and how long it stays there.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

Start

23 Jun 2023

lung cancer kidney cancer melanoma liver cancer colorectal cancer bladder cancer

What is this study about?

This study is about a cancer drug called nivolumab. You might have heard of it as Opdivo. It's a type of medicine that helps your body's own immune system fight cancer cells. Usually, this medicine is given through a drip into a vein, which means you have to stay in a clinic for a while. This study is testing a new way to give nivolumab: as an injection under the skin, much like some diabetes medicines are given.

The main idea is to see if giving the medicine this way works as well to get the right amount into your body, and if it's safe. It's an early-stage study, meaning it's one of the first times this new injection method is being looked at in people. Researchers will be carefully measuring how the medicine moves through your body and how long it stays there.

This study includes people with different types of advanced cancer, such as lung, kidney, melanoma, liver, colorectal (bowel), and bladder cancer. By studying people with various cancers, researchers can get a wider picture of how the new injection method works and if it could be a good option for different patients in the future. The safety of the injection will also be closely watched throughout the study.

Key takeaways

This study is testing a new, easier way to give nivolumab cancer medicine.
It's for people with specific advanced cancers like lung, kidney, and liver cancer.
The main goal is to see how the body absorbs the medicine and if it's safe.
This is an early-stage study, so new information is being gathered.
You will receive regular check-ups and blood tests if you participate.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would need to have been diagnosed with advanced lung, kidney, melanoma, liver, colorectal (bowel), or bladder cancer. Advanced cancer means the cancer has spread or cannot be removed by surgery.

There will be other health requirements and tests to make sure the study medicine is safe for you and that you can take part in the study properly. Your doctor will be able to check all the specific details to see if this study could be 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 lung, kidney, melanoma, liver, colorectal, or bladder cancer?
Are you able to attend appointments for blood tests and check-ups?
Are you able to understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the nivolumab medicine as an injection under your skin. The study team will take blood samples at different times to measure how much of the medicine is in your body and how long it stays there. This helps them understand if the new injection method works as expected.

You will also have regular check-ups with the study team to monitor your health and look for any side effects. They will ask you how you are feeling and if you have experienced any new symptoms. You'll likely have physical exams and blood tests throughout the study.

The overall duration of your participation in the study, including how many visits you'll need and how long follow-up will last, will be explained in detail by the study team. They will make sure you understand everything involved before you make a decision.

Potential risks and benefits

Taking part in this study could offer some benefits, such as potentially receiving nivolumab in a more convenient way if giving it as an injection under the skin proves effective. Being in a clinical trial also means you get very close medical attention from a dedicated team. However, there are potential risks, as with any medical treatment. Nivolumab can have side effects, and some may be serious. The study team will closely monitor you for any problems. You will be given a full list of possible side effects before you decide to join. Remember, taking part in any study is completely voluntary, and you can change your mind and stop participating at any time without it affecting your usual medical care.

Locations (5)

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
Netherlands
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Unverified
Italy
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Unverified
Poland
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Unverified
France

Common questions

What is nivolumab?

Nivolumab is a cancer medicine that helps your body's own immune system fight cancer cells. It's also known by the brand name Opdivo.

What kind of injection are we talking about?

This study is testing if nivolumab can be given as a simple injection under the skin, like some other medicines, instead of through a drip into a vein.

What types of cancer is this study for?

This study is for adults with advanced lung, kidney, melanoma (a type of skin cancer), liver, colorectal (bowel), or bladder cancer.

What are researchers hoping to learn?

They want to understand how the body uses and processes nivolumab when it's given as an injection under the skin, and to check for any side effects.

Will I still get my usual cancer care if I join this study?

Yes, joining a study doesn't stop you from receiving your standard care. The study aims to look at a new way of giving treatment within your overall care plan.