A Phase 3, Open-label, Randomized, Noninferiority Trial of the Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Had Received Prior Systemic Therapy
This study is looking into a new way to give a cancer medicine called Nivolumab to people with advanced kidney cancer. Currently, it's given through a drip into a vein, but this study will see if an injection under the skin works just as well. The main goal is to check how much of the medicine gets into the body with the injection compared to the drip. Researchers will also look at how effective it is in shrinking tumours, how long the effect lasts, and any side effects patients might experience. By finding out if the injection is as good and safe as the drip, this could make treatment more convenient for patients in the future.
At a glance
What is this study about?
This research study is about a medicine called Nivolumab, which is used to treat advanced kidney cancer, specifically a type known as clear cell renal cell carcinoma, after other treatments haven't worked. Currently, this medicine is given through a drip into a vein in your arm, which means patients usually have to spend time at a hospital for each treatment session.
Doctors want to find out if giving Nivolumab as a simple injection under the skin (like a flu jab) works just as well as the drip. This could make treatment much easier and more comfortable for patients. The study is called a 'Phase 3' trial, which means it's one of the final steps before a new treatment method can be approved for general use. They'll be comparing the two ways of giving the medicine to see if the injection is 'non-inferior' – meaning it's not worse than – the drip.
The main things the researchers will be checking are how much of the medicine gets into your blood and stays there over time, to make sure your body is getting the right amount to fight the cancer. They will also closely watch how your cancer responds to the treatment, if tumours shrink, and also keep a careful eye on any side effects you might experience with either method of receiving the drug. This will help them understand if the injection is a good and safe alternative for patients.
Key takeaways
- Compares two ways of giving Nivolumab: injection vs. IV drip.
- For advanced kidney cancer (clear cell renal cell carcinoma).
- Aims to check if the injection is as good and safe as the drip.
- Could make treatment more convenient for patients if successful.
- Participants will be closely monitored for effectiveness and side effects.
Who may be eligible?
To join this study, you must be at least 18 years old. The study is open to both men and women.
Important conditions for joining include having advanced or metastatic clear cell kidney cancer. This means your kidney cancer has spread to other parts of your body, and you've already had at least one other treatment for it.
The research team will also check other health details to make sure this study is safe and appropriate for you. They will review your medical history and current health status thoroughly.
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 or metastatic clear cell kidney cancer?
- Have you already received some other treatment for your kidney cancer?
- Are you able to travel to study appointments?
- Do you understand that you will be randomly assigned to a treatment group?
What does participation involve?
If you decide to join this study, you will be randomly assigned to receive Nivolumab either as an injection under the skin or as a drip into a vein. This means you won’t get to choose which way you receive the medicine.
You will have regular hospital visits for your treatment and to have various checks. These checks might include blood tests to measure the medicine levels in your body and to monitor your general health, scans to see how your cancer is responding, and assessments for any side effects. You will be monitored closely for safety and how well the treatment is working for up to 5 years, although the most frequent visits will be earlier in the study. The total time you participate in the study, including follow-up, could be up to 5 years, but the more active treatment and assessment period typically lasts for a few months to up to 2-3 years.
Potential risks and benefits
Locations (9)
- —UnverifiedItaly
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- —UnverifiedFinland
- —UnverifiedIreland
- —UnverifiedPoland
- —UnverifiedRomania
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedPortugal
Common questions
What is Nivolumab?
Nivolumab is a medicine used to treat certain cancers, including advanced kidney cancer. It works by helping your body's immune system fight the cancer.
What does 'subcutaneous' mean?
'Subcutaneous' means under the skin. So, a subcutaneous injection is a jab given just under the skin, like an insulin shot or some vaccines.
Why are doctors doing this study?
Doctors want to find out if giving Nivolumab as an injection under the skin is just as safe and effective as giving it through a drip into a vein. An injection might be more convenient for patients.
Will I get to choose how I receive the medicine?
No, you will be randomly assigned to either receive the medicine as an injection or through a drip. This is to make sure the study results are fair and unbiased.
What kind of kidney cancer is this study for?
This study is for people with advanced or metastatic clear cell kidney cancer who have already had some previous treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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