A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination with Palbociclib Versus Belzutifan Monotherapy in Participants with Advanced Renal Cell Carcinoma
This research study is looking into new treatments for a specific type of advanced kidney cancer. It's called a Phase 1/2 study, which means it first checks the safety and best dose of the treatments, and then goes on to see how effective they are. Participants will receive either a combination of two drugs, Belzutifan and Palbociclib, or Belzutifan on its own. The main aim is to understand how well these treatments shrink the cancer and if they cause any side effects. Researchers hope to find better ways to treat advanced kidney cancer, helping patients live longer and improve their quality of life. The study involves hospitals across different locations (multicenter) and everyone involved will know which treatment they are receiving (open-label).
At a glance
What is this study about?
This study is for people who have advanced kidney cancer, specifically a type called advanced clear cell renal cell carcinoma (ccRCC). When cancer is 'advanced', it means it has spread from where it started. Researchers are always looking for better ways to treat this condition.
In this study, doctors want to find out if giving two drugs together – Belzutifan and Palbociclib – is more effective than giving just Belzutifan on its own. Belzutifan is a drug that works by blocking a certain pathway that cancer cells use to grow. Palbociclib is another type of drug that can stop cancer cells from dividing and growing. By combining them, the researchers hope to get a stronger effect against the cancer.
The study has two parts. The first part focuses mainly on safety: finding out what dose works best and what side effects might occur. The second part looks at how well the treatments actually shrink the cancer. They will be measuring how many people respond to the treatment, how long that response lasts, and how long people live overall. This information will help doctors understand if these treatments could become new standard options for people with advanced kidney cancer.
Key takeaways
- This study is exploring new treatments for advanced kidney cancer.
- It aims to find out if two drugs together are better than one.
- Safety and effectiveness for shrinking tumours are key goals.
- Participation involves receiving one of the study treatments and regular check-ups.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, people generally need to be 18 years old or older. Both men and women can take part.
Beyond age and gender, there are specific medical criteria that a participant must meet, related to their health, the type and stage of their kidney cancer, and any previous treatments they may have had. These are in place to make sure the treatment is as safe as possible for everyone involved and that the study results are clear.
Your doctor or the study team will go through all the detailed requirements with you to check if you are a good fit for this research.
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 old or older?
- Do you have a diagnosis of advanced clear cell renal cell carcinoma (kidney cancer)?
- Are you willing to attend regular hospital appointments and undergo medical tests?
- Are you able to understand and sign the consent form?
- Do you meet other specific medical requirements (which the study team will explain)?
What does participation involve?
If you decide to join this study, you will either receive Belzutifan on its own or Belzutifan combined with Palbociclib. Which treatment you get will be decided by chance, like flipping a coin. You'll have regular visits to the hospital or clinic for assessments, which will include blood tests, body scans (like CT scans or MRI scans) to check the size of your cancer, and check-ups with the doctors to monitor your health and any side effects.
The drugs will be given to you in a way that is determined by the study protocol. The length of time you take part will depend on how you respond to the treatment and whether you experience any side effects. You will be closely monitored throughout the study, and there will be follow-up appointments even after you stop taking the study treatment. The total duration for each participant can vary, potentially lasting several months or even longer.
Potential risks and benefits
Locations (6)
- —UnverifiedSweden
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What kind of cancer is this study for?
This study is for advanced kidney cancer, specifically a type called advanced clear cell renal cell carcinoma (ccRCC).
What are the treatments being tested?
The study is testing Belzutifan on its own, and Belzutifan combined with another drug called Palbociclib.
What does 'Phase 1/2' mean?
Phase 1 means doctors are checking how safe the treatment is and finding the right dose. Phase 2 means they are then checking how well the treatment works against the cancer.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means you and your doctors will know which treatment you are receiving.
What will happen during the study visits?
You'll have regular check-ups, blood tests, and scans to see how you're feeling and how the treatment is affecting your cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.