Active not recruitingPHASE3INTERVENTIONAL

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

This research is looking into a new combination treatment for a type of kidney cancer called clear cell renal cell carcinoma (ccRCC) after surgery. Patients who have had their kidney and any visible tumours removed will receive either a new drug called belzutifan alongside pembrolizumab, or pembrolizumab with a dummy drug (placebo). The main goal is to find out if the belzutifan combination is better at preventing the cancer from coming back. It's a Phase 3 study, meaning it's in the later stages of testing new treatments, and involves a large number of participants to confirm if the new treatment is safe and effective.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

1,800

Start

15 Mar 2022

Estimated completion

28 Sep 2029

Carcinoma, Renal Cell

What is this study about?

This study focuses on a specific type of kidney cancer known as clear cell renal cell carcinoma (ccRCC). For many people, surgery to remove the kidney (nephrectomy) is the main treatment. However, sometimes there's a risk that the cancer might return. This research is testing whether a new combination of medicines can help reduce that risk after surgery.

The study involves two different medications: belzutifan and pembrolizumab. Pembrolizumab is an immunotherapy that works by helping your own immune system fight cancer cells. Belzutifan is a different type of drug that targets specific pathways involved in cancer growth. The study wants to see if adding belzutifan to pembrolizumab is more effective than pembrolizumab on its own (with a placebo, which looks like belzutifan but contains no active medicine) at preventing the cancer from coming back after surgery.

This is a 'Phase 3' study, which means it's a large and important step in evaluating a new treatment. Researchers will carefully compare the two groups of patients to see if the belzutifan combination leads to better outcomes, specifically looking at how long people remain free from the cancer returning. They will also closely monitor any side effects to ensure the treatment is safe.

Key takeaways

New study for clear cell kidney cancer after surgery.
Compares belzutifan plus pembrolizumab against pembrolizumab alone.
Aims to prevent cancer from returning.
Involves regular hospital visits and health monitoring.
Participation is voluntary; you can withdraw anytime.

Who may be eligible?

To join this study, participants must be at least 18 years old and have been diagnosed with clear cell kidney cancer that has a "clear cell component." This diagnosis must have been confirmed by a doctor, and you must have had surgery to remove your kidney (a nephrectomy) and any other visible cancer growths. This surgery must have taken place within the last 12 weeks.

Your cancer will also need to fit into certain risk categories, such as 'intermediate-high risk,' 'high risk,' or 'M1 with no evidence of disease.' This categorisation indicates the stage and aggressiveness of the cancer found after your surgery. You will also need to be generally well, able to perform daily activities with little difficulty, and have healthy organ function. For women who can become pregnant and men, effective contraception is required during and after the study for a specified period.

There are also some reasons why you might not be able to join. For example, if you've had major surgery (other than your kidney and tumour removal) in the last month, or if you have certain breathing problems requiring chronic oxygen support, this study might not be suitable for you. The study team will review all your medical information carefully to determine if you meet all the criteria.

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 or older?
Do you have a confirmed diagnosis of clear cell kidney cancer?
Have you had surgery to remove your kidney (and any other visible tumours) in the last 12 weeks?
Are you generally well and able to perform your daily activities?
Are you willing to use effective contraception if it applies to you?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve regular visits to the hospital for assessment and treatment. You would receive treatment either as intravenous (IV) infusions, which means medicine given directly into a vein, or as tablets you take by mouth. The study will last for a certain period, and you'll have follow-up appointments even after treatment ends to monitor your health and any long-term effects. These appointments will include physical examinations, blood tests, and scans to check for the return of cancer. The total duration of participation, including treatment and follow-up, will be detailed by the study team.

Potential risks and benefits

While we cannot predict individual outcomes, participants in clinical trials may benefit from receiving new treatments that are not yet widely available. However, there are also potential risks, as any medication can have side effects. These can vary from mild to severe, and the study team will monitor you closely for any adverse reactions. All known risks will be thoroughly explained before you decide to participate. Remember, taking part in a clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (285)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic in Arizona - Phoenix ( Site 3554)
Verified postcode
Phoenix, United States
City of Hope Comprehensive Cancer Center ( Site 3567)
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Duarte, United States
Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)
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La Jolla, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520)
Verified postcode
Los Angeles, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)
Verified postcode
Orange, United States
Stanford Cancer Center ( Site 3523)
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Palo Alto, United States
University of Colorado Anschutz Medical Campus ( Site 3514)
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Aurora, United States
Intermountain Health St. Mary's Regional Hospital ( Site 3562)
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Grand Junction, United States
Georgetown University Medical Center ( Site 3534)
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Washington D.C., United States
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517)
Verified postcode
Miami, United States
Moffitt Cancer Center ( Site 3540)
Verified postcode
Tampa, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)
Verified postcode
Marietta, United States

Common questions

What is clear cell renal cell carcinoma (ccRCC)?

It's the most common type of kidney cancer, originating in the lining of very small tubes in the kidney called renal tubules. 'Clear cell' refers to how the cancer cells look under a microscope.

What does 'post nephrectomy' mean?

It means 'after kidney removal surgery.' This study is for people who have already had their kidney, or part of it, removed due to cancer.

What is the difference between belzutifan and pembrolizumab?

Pembrolizumab is an immunotherapy that boosts your body's immune system to fight cancer. Belzutifan is a newer drug that targets cancer growth in a different way. This study is testing if they work better together.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used in some studies to compare the effects of the new drug against a 'no treatment' effect, while ensuring all participants are treated similarly.

Will I know which treatment I am receiving?

This is a 'blinded' study, meaning neither you nor your study doctor will usually know if you are receiving belzutifan plus pembrolizumab or placebo plus pembrolizumab. This helps ensure the study results are fair and unbiased.