A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination with Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
This study is for people in the UK with advanced kidney cancer that is inoperable, locally advanced, or has spread to other parts of the body. Your cancer must also have grown during or after treatment with a specific type of drug called an immune checkpoint inhibitor. The research aims to find out if a new combination treatment is more effective. One group of patients will receive two drugs, Atezolizumab and Cabozantinib, while another group will receive Cabozantinib alone. Researchers will compare how well these treatments stop the cancer from growing and how long people live. They will also carefully monitor any side effects to understand the safety of the new combination.
At a glance
What is this study about?
This clinical trial is designed for people living with a type of kidney cancer called renal cell carcinoma that has become advanced. This means the cancer either cannot be removed by surgery, has grown into nearby tissues, or has spread to other parts of the body (this is called metastatic cancer). Crucially, the cancer must also have shown signs of growth even after you've had a type of treatment known as an 'immune checkpoint inhibitor' which helps your own body's immune system fight the cancer.
The main goal of this study is to see if combining two different types of drugs works better than one of them alone. One drug is Atezolizumab (also known as Tecentriq), which is an immunotherapy. The other drug is Cabozantinib. We want to find out if giving these two drugs together can stop the cancer from growing for longer and help people live longer compared to just having Cabozantinib on its own.
We will also be carefully tracking other important things like how many people see their cancer shrink or disappear, how long any improvements last, and what side effects people might experience with the new combination. This information is vital to understand if this new treatment could be a good option for people with advanced kidney cancer that has been difficult to treat.
Key takeaways
- Focuses on advanced kidney cancer that has progressed after immunotherapy.
- Compares two drugs (Atezolizumab + Cabozantinib) against one (Cabozantinib).
- Aims to see if the combination helps control cancer for longer and improves survival.
- Carefully checks for side effects and how patients react to treatment.
- Open to adults aged 18 and over in the UK.
Who may be eligible?
This study is looking for both men and women aged 18 or older. There isn't an upper age limit. You would be considered if you have advanced kidney cancer (renal cell carcinoma) that doctors can't operate on, has spread locally, or has moved to other parts of your body.
It's important that your cancer has shown signs of growing or getting worse either during or after you've had previous treatment with a type of drug called an 'immune checkpoint inhibitor'. This study specifically focuses on people whose cancer has progressed after this particular kind of treatment.
There will be other detailed medical checks to make sure this study is safe and appropriate for you, but these are the main conditions to consider. Your doctor will be able to discuss all the specific requirements 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 kidney cancer (renal cell carcinoma) that is advanced or has spread?
- Has your cancer grown or gotten worse after a previous 'immune checkpoint inhibitor' treatment?
- Are you able to attend regular clinic visits and tests?
- Are you in general good health apart from your cancer?
What does participation involve?
If you join this study, you will be given study medication either through an infusion (drip) for Atezolizumab or as tablets for Cabozantinib. You would receive one of two treatment plans: either Atezolizumab combined with Cabozantinib, or Cabozantinib alone. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. We will regularly check your blood for levels of the study drugs and for any changes in your body. We will also ask you about any side effects you might be experiencing. The total duration of your participation in the study will depend on how you respond to the treatment and your health, but you will have follow-up appointments even after stopping study medication.
Potential risks and benefits
Locations (2)
- —UnverifiedPoland
- —UnverifiedGermany
Common questions
What type of cancer is this study for?
This study is for advanced kidney cancer (renal cell carcinoma) that has grown despite earlier immune-boosting treatment.
What are the treatments being tested?
The study compares a combination of two drugs, Atezolizumab and Cabozantinib, against Cabozantinib given alone.
What is the main goal of the study?
The main goals are to see if the combination treatment stops cancer from growing for longer and helps people live longer.
Who can join this study?
Adults aged 18 and over with advanced kidney cancer that has worsened after immune checkpoint inhibitor treatment may be eligible.
What is an 'immune checkpoint inhibitor'?
It's a type of drug that helps your body's own immune system find and fight cancer cells.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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