Study of Belzutifan and Palbociclib for Patients with Advanced Renal Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as advanced renal cell carcinoma. The study is investigating the effects of two medications: Belzutifan and Palbociclib. Belzutifan, also known by its code name MK-6482, is being tested both on its own and in combination with Palbociclib, which is also referred to by its code names PD-332,991 or PD-0332991. The purpose of the study is to understand how safe and tolerable these treatments are and to determine the best dose for further research.

Participants in the study will receive either Belzutifan alone or a combination of Belzutifan and Palbociclib. The study will be conducted in two parts. In the first part, researchers will focus on the safety and tolerability of the treatments. In the second part, they will evaluate how well the cancer responds to the treatments. The study will monitor participants for any side effects and how the cancer progresses over time.

This trial aims to provide valuable information on the effectiveness of these treatments for advanced renal cell carcinoma, potentially leading to better treatment options for patients in the future. The study is expected to continue until 2027, with recruitment starting in 2024.

1 joining the study

Upon joining the study, the participant is confirmed to have advanced renal cell carcinoma (RCC) with a clear-cell component. The participant must have experienced disease progression after receiving at least two systemic treatments for Stage IV RCC.

2 part 1: treatment initiation

The participant begins treatment with either belzutifan alone or in combination with palbociclib. Both medications are taken orally. The goal is to assess safety and determine the recommended dose for Phase 2.

Participants are monitored for any dose-limiting toxicities or adverse events. The number of participants who discontinue treatment due to adverse events is also recorded.

3 part 2: treatment continuation

In this phase, the objective response rate is evaluated using specific criteria. The participant continues with the assigned treatment regimen.

The study measures the clinical benefit rate, duration of response, progression-free survival, and overall survival. Adverse events and treatment discontinuations are also tracked.

4 study completion

The study is estimated to conclude by April 20, 2027. Throughout the study, participants are regularly assessed to ensure safety and to evaluate the effectiveness of the treatment.

Who Can Join the Study?

The patient must have a confirmed diagnosis of unresectable Stage IV RCC. This means the kidney cancer cannot be removed by surgery and has spread to other parts of the body.
The patient must have experienced disease progression after receiving at least two treatments for unresectable Stage IV RCC. These treatments must have included a type of therapy that targets the immune system (anti-PD-1/L1) and a therapy that targets blood vessel growth (VEGF-TKI).
The patient must have measurable disease. This means the cancer can be measured in size using specific criteria called RECIST 1.1, which are guidelines for assessing how tumors respond to treatment.
The patient must have recovered from all side effects caused by previous treatments.
Both male and female patients are eligible to participate.
The study does not include vulnerable populations, which means it is not designed for groups that might need special protection.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not reached the required age range for the study.
Patients who are pregnant or breastfeeding.
Patients who have a serious medical condition that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery.
Patients who have an active infection that requires treatment.
Patients who have a history of allergic reactions to the study medications.
Patients who have a mental health condition that could affect their ability to participate.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Hospital Universitario 12 De Octubre	Madrid	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Karolinska University Hospital	Solna	Sweden
Hopital Beaujon	Clichy	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Upsatvl Uanihszgfi Hefcxuik	Uppsala	Sweden
Ndgdvzch Izteswpv Oseeabqwd Isr Mwmzy Sxmesfzdphiiwzreinwsntsoxuis Igynanjo Bcluuiio	Cracow	Poland
Ctboxq Hkovodqvwav Rvdvxhtz Diijheeqlluxeh	Angers	France
Husjmgxk Vloy dktozkay	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.02.2026
Germany	Not recruiting	01.02.2026
Italy	Not recruiting	01.02.2026
Poland	Not recruiting	01.02.2026
Spain	Not recruiting	01.02.2026
Sweden	Not recruiting	01.02.2026

Trial locations

Investigated drugs:

Belzutifan is a medication being studied for its potential to treat advanced renal cell carcinoma. It is being tested both on its own and in combination with another medication to see how effective it is in treating this type of cancer.

Palbociclib is another medication involved in this study. It is being combined with belzutifan to determine if the combination is more effective than belzutifan alone in treating advanced renal cell carcinoma. Palbociclib is known to work by inhibiting certain proteins that are involved in cell division, which may help slow down the growth of cancer cells.

Advanced Clear Cell Renal Cell Carcinoma – This is a type of kidney cancer that originates in the cells lining the small tubes within the kidney. It is characterized by the presence of clear cells when viewed under a microscope. As the disease progresses, it can spread to other parts of the body, including the lungs, bones, and liver. Patients may experience symptoms such as blood in the urine, pain in the side or back, and unexplained weight loss. The disease is often diagnosed at an advanced stage due to its subtle early symptoms. Advanced stages may lead to more pronounced symptoms and complications as the cancer affects additional organs.

Trial ID:

2023-504963-17-00

Protocol code:

MK-6482-024

NCT ID:

NCT05468697

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Belzutifan and Palbociclib for Patients with Advanced Renal Cell Carcinoma

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