A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants with First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)
This study, called KEYNOTE-B61, is testing a new treatment combining two drugs, Lenvatinib and KEYTRUDA, for adults with a specific type of advanced kidney cancer known as non-clear cell renal cell carcinoma (nccRCC). This is a 'Phase 2' study, meaning it's an early but important step to see how effective the treatment is. Researchers want to find out how many patients respond to the treatment by seeing if their tumours shrink or disappear. They will also look at how long any response lasts, how long people live without their cancer getting worse, and how long they live overall. Safety is also a key focus, monitoring any side effects or reasons patients might need to stop the medication.
At a glance
What is this study about?
This clinical trial is designed to investigate a new approach to treating a specific type of kidney cancer called non-clear cell renal cell carcinoma, often shortened to nccRCC. This refers to kidney cancers that don't look 'clear' under the microscope, unlike the more common clear cell type. When the cancer is 'advanced' or 'metastatic', it means it has either spread beyond the kidney or is difficult to remove. This study is for people who are receiving treatment for the first time for this condition.
The trial combines two medicines: Lenvatinib and KEYTRUDA. Lenvatinib is a tablet medicine, and KEYTRUDA is given through a drip into a vein. Researchers want to understand how well this combination works together to fight the cancer. This is a 'Phase 2' study, which means it builds on earlier research and aims to get a clearer picture of the treatment's effectiveness and safety in a larger group of patients before potentially moving to bigger, later-stage trials.
The main goal is to see how many patients respond to the treatment, which means checking if their tumours shrink or disappear. They will also track how long patients continue to respond well to the treatment, how long they live without their cancer getting worse, and their overall survival. Importantly, the study will also carefully monitor any side effects to understand the safety of this new treatment combination.
Key takeaways
- This study tests a new two-medication combo for a specific kidney cancer.
- It's for adults whose cancer has spread or is hard to treat, and who haven't had prior treatment.
- The main aim is to see how many patients respond (tumour shrinkage).
- Safety is carefully monitored, tracking any side effects.
- Participation involves taking tablets and having regular drips, plus clinic visits and scans.
- You can leave the study at any time without affecting your future care.
Who may be eligible?
This study is looking for adult men and women, aged 18 and over, who have a specific type of kidney cancer called non-clear cell renal cell carcinoma (nccRCC). Your cancer needs to be considered 'advanced' or 'metastatic,' meaning it has either grown locally and can’t be removed by surgery, or has spread to other parts of the body. You must also be starting treatment for this cancer for the very first time.
There might be other health conditions or previous treatments that would mean you couldn't join the study. These could include certain heart problems, other types of cancer, or ongoing infections. The study team will review all your medical information carefully.
It's important that you are generally well enough to take part in the study and that you are able to follow all the study procedures, including attending regular appointments and taking the medication as prescribed. Your doctor will discuss all the detailed requirements with you to see if this study is a good fit.
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?
- Have you been diagnosed with non-clear cell renal cell carcinoma (nccRCC)?
- Is your cancer considered 'advanced' or 'metastatic'?
- Are you due to start your first treatment for this specific type of advanced kidney cancer?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would primarily receive two study medications: Lenvatinib, which is a tablet you take by mouth, and KEYTRUDA, which is given as a liquid through a drip into a vein, usually every few weeks. You would have regular visits to the clinic for check-ups, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is working. These scans help the doctors see if your cancer is shrinking or staying stable.
The study team would also routinely track any side effects or changes to your health, which you would need to report. The total duration of your participation would depend on how well you respond to the treatment and if you experience any side effects. You would continue treatment for as long as it is benefiting you and you are tolerating it well. Even after stopping treatment, there would be follow-up appointments to monitor your long-term health.
Potential risks and benefits
Locations (5)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedFrance
Common questions
What is 'non-clear cell renal cell carcinoma'?
It's a less common type of kidney cancer that looks different under the microscope compared to the more common 'clear cell' type.
What does 'first-line advanced/metastatic' mean?
It means your cancer has spread or is difficult to remove, and this would be the first new treatment you receive for it.
What kind of medicines are Lenvatinib and KEYTRUDA?
Lenvatinib is a tablet, and KEYTRUDA is given by drip; both are designed to help fight cancer in different ways.
What does 'Objective Response Rate' mean for me?
It's a way for doctors to measure how many patients' tumours shrink or disappear after receiving the treatment.
Will I know if I'm getting the active drugs?
Yes, in this study (single-arm, open-label), all participants will receive the Lenvatinib and KEYTRUDA combination.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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