Active not recruitingPHASE3INTERVENTIONAL

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

This research study is looking at new ways to treat a type of advanced kidney cancer called renal cell carcinoma (RCC) that has a 'clear cell' component. We're comparing two different treatment approaches for people whose cancer has progressed after earlier drug therapy. One approach uses a combination of two medications, belzutifan and lenvatinib. The other approach uses a single medication called cabozantinib. The main goal is to see if the belzutifan and lenvatinib combination is better than cabozantinib at stopping the cancer from growing (progression-free survival) or helping people live longer (overall survival). We will also look at the safety of these treatments. This is a Phase 3 study, meaning it's a key step in seeing if a new treatment could become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

747

Start

25 Feb 2021

Estimated completion

11 Feb 2027

Carcinoma, Renal Cell

What is this study about?

This research study is focused on a type of kidney cancer called renal cell carcinoma (RCC), specifically when it's advanced and has a 'clear cell' component. When we say 'advanced,' it means the cancer has spread or grown within the body and surgery isn't an option. The study is for people who have already had some treatment for their cancer, but unfortunately, it has started to grow again or progress.

The main idea behind this study is to compare two different ways of treating this advanced kidney cancer. One option uses a combination of two medications: belzutifan and lenvatinib. The other option uses a single medication called cabozantinib. All these medications are designed to fight cancer, but they work in different ways. Researchers want to find out if combining belzutifan and lenvatinib might be more effective than cabozantinib alone, and if it's safe to use.

The aim is to see which treatment helps people live longer without their cancer getting worse, and whether it helps them live longer overall. By comparing these treatments, doctors hope to find a better standard of care for people with this challenging form of kidney cancer. Participating in a study like this helps advance medical understanding and could lead to improved treatments for future patients.

Key takeaways

This study compares two different drug treatments for advanced kidney cancer.
It's for people whose cancer has progressed after previous treatment.
The goal is to find out if a new combination treatment is better and safer.
Participation involves regular clinic visits, tests, and taking study medication.
You can stop participating in the study at any time.
It's a Phase 3 study, meaning it's an important step toward potentially improving future kidney cancer treatments.

Who may be eligible?

To join this study, you would need to have advanced kidney cancer (renal cell carcinoma) with a 'clear cell' type, and it must have progressed after at least one previous treatment. The previous treatment would have included a specific type of immunotherapy (anti-PD-1/L1 therapy), either as your first or second treatment for advanced cancer, or as a treatment after surgery if your cancer returned within six months.

Your doctors would need to see that your cancer can be measured accurately in scans, and that you are generally well enough to take part, meaning you can mostly go about your daily activities. You can't have had more than two previous treatments in total for your advanced kidney cancer. Your blood pressure needs to be well-controlled, and your main body organs (like kidneys and liver) need to be working properly.

There are also specific requirements regarding birth control for both men and women to ensure safety during the study, as the medications can affect unborn babies. For women, you cannot be pregnant or breastfeeding. You would not be able to join if you have very low oxygen levels, require oxygen support, or if you have another significant type of cancer.

Quick self-check

Do I have advanced kidney cancer (renal cell carcinoma) with a 'clear cell' type?
Has my cancer grown or progressed after at least one previous treatment?
Did my prior treatment include a specific type of immunotherapy (anti-PD-1/L1)?
Am I generally well enough to carry out most daily activities?
Is my blood pressure well-controlled?
Am I not pregnant or breastfeeding (for women)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive either the combination of belzutifan and lenvatinib, or cabozantinib. This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your cancer and overall health. The specific schedule of visits and tests will be explained in detail by the study team.

During these visits, the doctors will assess how you are responding to the treatment and check for any side effects. You will be given the study medication to take as instructed. The total duration of your participation will depend on how you respond to the treatment and will continue for as long as the treatment is beneficial and safe for you, or until the study concludes. After stopping the study medication, there will be follow-up appointments to monitor your health.

Potential risks and benefits

Taking part in this study could offer the potential benefit of receiving a new or experimental treatment that might be more effective for your cancer. However, there are also potential risks involved, as all medications can cause side effects. These side effects can range from mild to serious, and the study team will monitor you closely and explain all known risks. It's important to remember that there's no guarantee the treatment will work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (184)

Ironwood Cancer & Research Centers ( Site 0077)
Chandler, United States
Cedars Sinai Medical Center ( Site 0027)
Los Angeles, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0048)
Los Angeles, United States
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)
Orange, United States
University of California, Irvine ( Site 0029)
Orange, United States
Providence Saint John's Health Center ( Site 0083)
Santa Monica, United States
Georgetown University Medical Center ( Site 0006)
Washington D.C., United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0003)
Orlando, United States
Orlando Health, Inc. ( Site 0035)
Orlando, United States
University Cancer & Blood Center, LLC ( Site 0057)
Athens, United States
Emory University Hospital ( Site 0012)
Atlanta, United States
Rush University Medical Center ( Site 0040)
Chicago, United States

+172 more sites — see the official record for the full list.

Common questions

What is 'renal cell carcinoma'?

It's the most common type of kidney cancer.

What does 'advanced' cancer mean in this study?

It means the cancer has spread or grown beyond its original location, and surgery isn't a treatment option.

What is a 'Phase 3' study?

This is a large study comparing a new treatment to a standard one, hoping to show it's better and safe enough for wider use.

Will I know which treatment I'm getting?

In many studies like this, treatments are given randomly, and sometimes neither you nor your doctor will know which one you are receiving until the study concludes, to keep the results fair.

What if the treatment isn't working or I feel unwell?

Your health will be closely monitored, and your doctor will discuss options with you, including stopping the study treatment if it's not safe or beneficial.