Active not recruitingPHASE2INTERVENTIONAL

A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

This research study is investigating an experimental medication called belzutifan, specifically for people who have advanced kidney cancer (renal cell carcinoma) with a clear cell component. This means the cancer has spread beyond the kidney or can't be removed with surgery. We're interested in patients whose cancer has continued to grow even after receiving previous treatments, particularly a type of immunotherapy called anti-PD-1/L1 therapy. The main goal is to compare two different doses of belzutifan to see if a higher dose is more effective at shrinking the cancer or stopping its growth, while also checking how safe both doses are. This study aims to find better treatment options for this specific type of kidney cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

154

Start

13 Sep 2020

Estimated completion

04 Oct 2026

Carcinoma, Renal Cell

What is this study about?

This study is looking into a new medication called belzutifan for people living with advanced kidney cancer. Kidney cancer that is 'advanced' means it has spread from where it started, or it is too big to be removed by surgery. This particular study focuses on a common type of kidney cancer called 'clear cell renal cell carcinoma'. Doctors want to find out if belzutifan can help control this cancer, especially for patients whose cancer has progressed after other treatments.

Specifically, this research is interested in people who have already received a type of treatment called immunotherapy (anti-PD-1/L1 therapy), and whose cancer has unfortunately started to grow again. The study is comparing two different doses of belzutifan – a standard dose and a slightly higher dose – to see which one works best at shrinking the cancer or stopping it from growing further. They are also carefully watching for any side effects at both dose levels to make sure the treatment is safe.

Finding new and effective treatments for advanced kidney cancer is very important. This study hopes to gather important information about belzutifan that could lead to better options for patients in the future. It's a key step in understanding how this new drug might help people whose cancer hasn't responded well to previous therapies.

Key takeaways

This study is for advanced kidney cancer (clear cell type) that has progressed after prior treatment.
It tests a new drug called belzutifan at two different doses.
The main goal is to find out if a higher dose works better and is safe.
Participants must have previously received anti-PD-1/L1 immunotherapy.
Regular hospital visits, tests, and scans will be part of the study.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have advanced kidney cancer (renal cell carcinoma) that doctors have confirmed to be of the 'clear cell' type. It's important that your cancer has already grown or spread, and that your doctors can measure this growth.

You would be considered for this study if your cancer has continued to progress even after you've had immunotherapy treatment (specifically, anti-PD-1/L1 therapy). This immunotherapy must have been your most recent treatment. You should not have had more than three different types of cancer treatments for your advanced kidney cancer in total.

Also, you need to be generally well enough to take part in the study, meaning you can carry out most of your daily activities. If you are female and could become pregnant, or if you are male, you would need to use effective birth control during and for a period after the study.

Quick self-check

Do I have advanced kidney cancer (clear cell type)?
Has my cancer gotten worse after previous treatments, especially immunotherapy?
Have I had no more than three previous treatments for my advanced kidney cancer?
Am I generally well enough to carry out daily activities?
Am I willing to use effective birth control if applicable?

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'll be given belzutifan, which is an experimental drug, at one of two different dose levels. You won't know which dose you're getting at first, but all participants will receive the active drug. You'll have regular hospital visits for check-ups, blood tests, and scans to see how the treatment is working and to monitor any side effects. You'll also need to provide a tissue sample from your cancer, either from an existing sample or by having a new small procedure.

These visits will happen regularly throughout the treatment period. The total duration of your participation will depend on how you respond to the treatment and for how long you and your study doctor decide it's safe and beneficial for you to continue. Before starting, doctors will make sure you’ve recovered from any side effects of previous treatments. There will also be follow-up appointments after you stop taking the study drug.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive an experimental treatment that might help your condition, especially if other treatments haven't worked. However, there's no guarantee the treatment will be effective, and you may experience side effects, some of which could be serious or unexpected. The study team will carefully monitor you for any problems. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (48)

Georgetown University Medical Center ( Site 0002)
Washington D.C., United States
Univ of Miami- Sylvester Comprehensive Cancer Center ( Site 0023)
Miami, United States
Norton Cancer Institute - St. Matthews ( Site 0025)
Louisville, United States
Weinberg Cancer Institute at Franklin Square ( Site 0007)
Baltimore, United States
Cancer Partners of Nebraska ( Site 0003)
Lincoln, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0012)
Omaha, United States
New York Oncology Hematology P.C ( Site 0028)
Albany, United States
Roswell Park Cancer Institute ( Site 0038)
Buffalo, United States
Fox Chase Cancer Center ( Site 0026)
Philadelphia, United States
Sanford Cancer Center Oncology Clinic ( Site 0031)
Sioux Falls, United States
UT West Cancer Center ( Site 0032)
Germantown, United States
Urology Associates ( Site 0015)
Nashville, United States

+36 more sites — see the official record for the full list.

Common questions

What is 'advanced kidney cancer'?

This means the cancer has spread from your kidney to other parts of your body, or it's too large to be removed by surgery.

What is belzutifan?

Belzutifan is a new drug being tested to treat kidney cancer. It's not yet approved for general use, so it's considered an experimental treatment.

What does 'clear cell component' mean?

This refers to the specific type of kidney cancer cells seen under a microscope. It's the most common type of kidney cancer.

What is 'PD-1/L1 therapy'?

This is a type of immunotherapy that helps your body's immune system fight cancer. If you've had this treatment before and your cancer grew, this study might be for you.

Will I definitely get the higher dose of belzutifan?

No, you will be assigned to either a standard dose or a higher dose of belzutifan. The study is comparing the two, so you won't know which one you're receiving at first.