RecruitingPHASE3INTERVENTIONAL

Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)

This study, called an "extension trial," aims to understand the long-term effects of a trial medicine named belzutifan. It's for people who have advanced cancers that have spread or can't be removed by surgery, or cancers specifically linked to a genetic condition called Von Hippel-Lindau (VHL) disease. VHL disease is passed down in families and increases the risk of certain cancers. Belzutifan is designed to block a protein that helps tumors grow, potentially slowing down or stopping their development. This trial is only open to those who are already taking belzutifan in certain previous research studies. Researchers want to learn more about how long people live after they start taking this medicine.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

450

Start

23 Mar 2026

Estimated completion

14 Jan 2034

Von Hippel-Lindau Disease Carcinoma, Renal Cell

What is this study about?

This research is looking for better ways to treat advanced cancers that have spread to other parts of the body or can't be removed with an operation. It's also for a specific type of cancer linked to a condition called Von Hippel-Lindau (VHL) disease. VHL disease is a genetic condition that runs in families and makes people more likely to develop certain kinds of tumours.

The study focuses on a new medicine called belzutifan (you might also see it called MK-6482). This medicine is designed to stop a specific protein that helps cancer cells grow and survive. By blocking this protein, belzutifan aims to slow down or even shrink tumours.

This is an "extension study." This means it's not a study for completely new patients. Instead, it's for people who are already taking belzutifan as part of other ongoing research studies. The main goal is to understand the long-term benefits of belzutifan, particularly how it affects how long people live after starting the treatment.

Key takeaways

This study is for long-term follow-up of belzutifan.
It's for people with advanced cancer or VHL-related tumours.
Only open to those already taking belzutifan in other studies.
Aims to understand how long people live after starting treatment.
Belzutifan is designed to block a protein that helps tumours grow.

Who may be eligible?

To be considered for this study, you must already be taking belzutifan as part of another research study (called a 'parent study') for advanced cancers or cancers linked to Von Hippel-Lindau disease.

However, you would not be able to join if you are currently experiencing a serious side effect from the treatment in your current study, unless you have fully recovered and are well enough to be out of hospital. Also, if your treatment in the original study has been paused because of a side effect, you wouldn't be able to join this new study until your treatment has restarted in your original study.

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.

I am currently taking part in another study using belzutifan.
My current study is for advanced solid tumours or VHL-related tumours.
I am not currently having a serious side effect that requires me to be in hospital from my current treatment.
My belzutifan treatment in my original study has not been stopped because of a side effect (or it has started again if it was paused).

Answer every question to see your result.

What does participation involve?

As this is an extension study, you are already familiar with taking belzutifan. If you decide to join, you would continue to take belzutifan as directed by the study team. You would have regular check-ups and appointments with the study doctors and nurses to monitor your health and how the treatment is affecting you. These visits might involve blood tests, scans, and discussions about any side effects you might be experiencing. The main aim is to follow you over time to understand the long-term effects of belzutifan.

Potential risks and benefits

Like all medicines, belzutifan can have side effects, and the study team will carefully monitor you for any issues. There's also no guarantee that the treatment will work for everyone. However, for those who have responded well to belzutifan in previous studies, continuing the treatment might offer a potential benefit in managing their condition. You are free to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (24)

Beth Israel Deaconess Medical Center ( Site 0107)
Verified postcode
Boston, United States· Recruiting
Dana-Farber Cancer Institute ( Site 0105)
Verified postcode
Boston, United States· Recruiting
Karmanos Cancer Center ( Site 0108)
Verified postcode
Detroit, United States· Recruiting
START San Antonio ( Site 0104)
Verified postcode
San Antonio, United States· Recruiting
UZ Leuven ( Site 0900)
Verified postcode
Leuven, Belgium· Recruiting
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000)
Verified postcode
Olomouc, Czechia· Recruiting
Tampereen yliopistollinen sairaala ( Site 1305)
Verified postcode
Tampere, Finland· Recruiting
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501)
Verified postcode
Budapest, Hungary· Recruiting
Rambam Health Care Campus ( Site 1600)
Verified postcode
Haifa, Israel· Recruiting
Hadassah Medical Center ( Site 1604)
Verified postcode
Jerusalem, Israel· Recruiting
Rabin Medical Center ( Site 1602)
Verified postcode
Petah Tikva, Israel· Recruiting
Sourasky Medical Center ( Site 1603)
Verified postcode
Tel Aviv, Israel· Recruiting

Common questions

What is an 'extension study'?

An extension study means it's a follow-up study for people who are already taking part in another research study for a medicine. It helps researchers learn about the long-term effects.

What is Von Hippel-Lindau (VHL) disease?

VHL disease is a genetic condition that runs in families and increases a person's risk of developing certain types of tumours, including kidney cancer.

What does 'advanced solid tumors' mean?

Advanced solid tumors are cancers that have spread to other parts of the body (cancer doctors call this 'metastatic') or can't be easily removed through surgery.

What is belzutifan?

Belzutifan is a trial medicine that aims to block a specific protein that helps cancer cells grow. By blocking this protein, it might slow down or stop the cancer's growth.

Can I join this study if I haven't been in another belzutifan trial?

No, this study is only for people who are already taking belzutifan as part of certain previous research studies.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.