A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
This research study is looking at advanced kidney cancer, specifically a type called clear cell renal cell carcinoma. We want to find out if new combinations of existing medicines – pembrolizumab, belzutifan, lenvatinib, and quavonlimab – work better than the current standard treatment (pembrolizumab and lenvatinib). The main goal is to see if these new combinations can help people live longer and prevent the cancer from getting worse. This is for people who are being treated for their advanced kidney cancer for the first time. The study will also carefully check how safe these new treatments are. By participating, you could help doctors learn more about the best ways to treat this type of cancer.
At a glance
What is this study about?
This study is investigating new ways to treat a type of advanced kidney cancer called clear cell renal cell carcinoma. When cancer is advanced, it means it has spread from where it started. Currently, a combination of two drugs, pembrolizumab and lenvatinib, is a common treatment. This study wants to see if adding another drug, or using a different combination of drugs, could be even more effective.
The researchers are comparing two new treatment combinations against the standard treatment. One new combination adds a drug called belzutifan to pembrolizumab and lenvatinib. The other new combination uses pembrolizumab/quavonlimab (a combination of two drugs already together) with lenvatinib. The main questions the study hopes to answer are: Do these new combinations help people live longer without their cancer getting worse? And do they help people live longer overall?
By comparing these treatments, doctors hope to find better ways to manage advanced kidney cancer. This could lead to improved outcomes for patients in the future. All treatments will be carefully monitored for both how well they work and any side effects they might cause.
Key takeaways
- Tests new drug combinations for advanced clear cell kidney cancer.
- Compares new treatments against a current standard treatment.
- Aims to improve how long people live and prevent cancer spread.
- For patients who haven't had previous whole-body treatment for advanced cancer.
- Closely monitors safety and effectiveness of the drugs.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To join this study, you would need to have been diagnosed with kidney cancer that has a 'clear cell' component and is considered advanced. This must be your first time receiving a full body treatment for this advanced kidney cancer. You also need to be in generally good health, meaning your blood pressure is controlled and your organs are working properly.
There are certain situations that would prevent you from taking part. For example, if you have another type of cancer that is currently active or needed treatment recently, or if you've had major surgery (other than kidney removal) in the last month. Also, issues like cancer spread to the brain, recent radiation therapy, significant heart disease, certain lung conditions, or a weakened immune system might mean this study isn't right for you.
- Do you have advanced clear cell kidney cancer?
- Have you *not* had any other full-body treatment for your advanced kidney cancer yet?
- Is your general health, including blood pressure and organ function, good?
- Are you able to use contraception if needed, or are you past child-bearing age?
- Do you *not* have other active cancers, brain metastases, or serious heart/lung conditions recently?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular visits to the clinic for assessments. You would be given one of the study medications – either pembrolizumab plus belzutifan plus lenvatinib, pembrolizumab/quavonlimab plus lenvatinib, or pembrolizumab plus lenvatinib. The doctors and nurses would monitor your health very closely throughout the study, performing blood tests, scans, and physical examinations to see how you are responding to the treatment and to check for any side effects. You would continue treatment as long as it is working for you and you are tolerating it well. After you stop treatment, there will be follow-up visits or calls to track your health over time. The exact duration of your involvement could vary depending on your individual response to the treatment.
Potential risks and benefits
Locations (262)
- The University of Alabama at Birmingham ( Site 0010)Birmingham, United States
- UC San Diego ( Site 0050)La Jolla, United States
- Cedars Sinai Medical Center ( Site 0027)Los Angeles, United States
- University of California Irvine ( Site 0029)Orange, United States
- UCLA Hematology Oncology Santa Monica ( Site 0048)Santa Monica, United States
- Hartford Hospital ( Site 0024)Hartford, United States
- Advent Health Hematology & Oncology ( Site 0003)Orlando, United States
- University Cancer & Blood Center, LLC ( Site 0057)Athens, United States
- Emory University Winship Cancer Institute ( Site 0012)Atlanta, United States
- Rush University Medical Center ( Site 0040)Chicago, United States
- Parkview Cancer Institute ( Site 0088)Fort Wayne, United States
- Norton Cancer Institute - St. Matthews ( Site 0065)Louisville, United States
+250 more sites — see the official record for the full list.
Common questions
What type of kidney cancer is this study for?
This study is specifically for advanced clear cell renal cell carcinoma, which is a common type of kidney cancer.
Will I know which treatment I'm getting?
No, in this type of study, you won't know which specific combination of medicines you are receiving. This helps make the study results fair and unbiased.
What are 'advanced' cancer treatments?
Advanced means the cancer has spread from where it started. 'Advanced treatments' refer to medicines given by injection or by mouth that act throughout the body.
How long would I be on the treatment?
You would continue treatment as long as it is helping your cancer and you are not experiencing severe side effects. This varies for each person.
Will I have to pay for the study drugs?
No, all study-related treatments and tests will be provided at no cost to you.
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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