A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)
This research study, called KEYNOTE-679/ECHO-302, is for adults with advanced kidney cancer that has spread or is hard to treat. Doctors are testing a new combination of two medicines, pembrolizumab (also known as KEYTRUDA) and another drug called epacadostat. They want to see if this new treatment helps shrink the cancer or stop it from growing more effectively than current standard treatments like sunitinib (Sutent) or pazopanib. The main goal is to find out how many people respond to the new treatment. They will also carefully monitor any side effects to make sure the new treatment is safe and well-tolerated.
At a glance
What is this study about?
This study is a Phase 3 clinical trial, which means it's one of the final steps in testing a new treatment before it might become widely available. Doctors are focusing on advanced kidney cancer, which is cancer that has either grown beyond the kidney itself and is hard to remove, or has spread to other parts of the body. This type of cancer is also known as metastatic renal cell carcinoma (mRCC).
The trial is comparing a new approach using two drugs together: pembrolizumab (KEYTRUDA) and epacadostat, against current standard treatments (sunitinib or pazopanib). Pembrolizumab is an immunotherapy that works by helping your body's own immune system fight cancer. Epacadostat is designed to block a pathway that some cancers use to hide from the immune system. The hope is that by combining these two drugs, the treatment will be more effective.
The main thing researchers want to find out is a measure called the 'Objective Response Rate'. This means they will look at how many people's cancers shrink or disappear after receiving the new treatment compared to those on standard care. They will also be very carefully tracking any side effects or unwanted reactions to the medications, to ensure the new combination is safe and doesn't cause too many problems for patients.
Key takeaways
- This study tests a new two-drug combination for advanced kidney cancer.
- It compares the new treatment against existing standard treatments.
- The main aim is to see if the new treatment shrinks cancer more effectively.
- Safety and side effects are carefully monitored throughout the study.
- It's a Phase 3 study, meaning it's a key step in developing new medicines.
- Participation involves regular medical checks and receiving study medication.
Who may be eligible?
To join this study, you must be 18 years old or older. The study is open to both men and women.
Only people with kidney cancer that has spread to other parts of the body (metastatic) or is advanced locally and cannot be removed by surgery are suitable for this trial. Your doctors will need to check your medical history and current health carefully to make sure the study is right for you.
There might be other health checks or specific medical conditions that mean you can't take part, but your doctor will discuss all of these details with you if you're interested.
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 advanced or metastatic kidney cancer?
- Are you able to travel to the study clinic for appointments?
- Are you open to potentially receiving either a new treatment or a standard treatment (decided by chance)?
- Are you willing to have regular medical tests and check-ups?
What does participation involve?
If you decide to take part in this study, you would receive either the new combination treatment (pembrolizumab plus epacadostat) or one of the standard treatments (sunitinib or pazopanib). You won't get to choose which treatment you receive; it's decided randomly, like flipping a coin. You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. This will help doctors track the cancer's response and any side effects. The medications are given either as capsules you take by mouth (sunitinib or pazopanib, and epacadostat) or as an infusion into a vein (pembrolizumab). The study will last for a certain period, and even after you stop treatment, there will be follow-up appointments to check on your long-term health. The total duration of participation and specific schedule of visits will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is advanced kidney cancer?
Advanced kidney cancer means the cancer has either spread from the kidney to other parts of your body or is locally advanced, making it difficult to treat with surgery alone.
What are pembrolizumab and epacadostat?
Pembrolizumab (KEYTRUDA) is a drug that helps your immune system fight cancer. Epacadostat is another drug being tested with it, designed to boost this immune response.
What are the standard treatments being compared?
The standard treatments are sunitinib (Sutent) or pazopanib. These are common medications used for kidney cancer.
Will I know which treatment I'm receiving?
Yes, this is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.
What does 'Objective Response Rate' mean?
It means how many people's cancers either shrink in size or disappear completely after treatment, as measured by doctors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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