Not recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

10 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Verified
Centre Hospitalier Regional D'Angers
Angers, France
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Belzutifan
Belzutifan is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced renal cell carcinoma (ccRCC). The medication works by inhibiting a protein called HIF-2α, which plays a role in tumor growth and survival. Belzutifan is classified as a hypoxia-inducible factor inhibitor, and it is being evaluated for its safety, tolerability, and potential to improve response rates in cancer treatment.
Palbociclib
Palbociclib is also taken orally as a capsule. It is an established medication used primarily in the treatment of certain types of breast cancer, and it is now being investigated in combination with belzutifan for advanced renal cell carcinoma. Palbociclib functions by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), which are involved in cell division. This medication is classified as a CDK inhibitor and is being studied for its potential to enhance the therapeutic effects of belzutifan in cancer therapy.

Investigated diseases

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.