C6461008 - AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
This research study is investigating an experimental medicine called PF-08634404 for adults with advanced kidney cancer that has spread to other parts of the body. The main goals are to understand how safe the new medicine is and how well it helps control the cancer. Researchers are testing PF-08634404 in two ways: first, on its own; and second, in combination with other anti-cancer drugs that are already used, such as ipilimumab or axitinib. The study will carefully look at any side effects people experience and whether the tumours get smaller. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in a larger group of people with this condition.
At a glance
What is this study about?
This study is for people in the UK who have advanced kidney cancer (renal cell carcinoma) that has spread to other parts of their body, known as metastatic cancer. Doctors and researchers are trying to find new and better ways to treat this type of cancer. They are particularly interested in a new medicine called PF-08634404.
The study has two main goals: firstly, to check how safe this new medicine is for patients. Like all medicines, it might have side effects, and the researchers need to understand what these are and how common they might be. Secondly, they want to see how effective the medicine is. This means looking at whether it can help shrink the cancer or stop it from growing. They are testing PF-08634404 by itself and in combination with other anti-cancer drugs that are already used, such as ipilimumab and axitinib, to see if combining them works better.
This is called a 'Phase 1B/2' study. This means it's still in the earlier stages of drug development. Phase 1B often involves testing different doses and looking closely at safety, while Phase 2 aims to get a better idea of how well the treatment works in a larger group of patients. The study involves different groups of patients (called cohorts) who will receive different treatments. The information gathered will help researchers decide if this new medicine should be studied further.
Key takeaways
- Targets adults with advanced or metastatic kidney cancer.
- Investigates a new medicine, PF-08634404, on its own and with other cancer drugs.
- Aims to assess safety and how well the treatment shrinks tumours.
- Involves regular clinic visits, blood tests, and scans.
- Participation may offer access to a new treatment, but also carries potential risks/side effects.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, participants need to be adults aged 18 or older. Both men and women can take part. The study is specifically for people who have kidney cancer that is considered 'advanced' or has spread to other parts of the body.
There will be other detailed medical criteria that you would need to meet to be eligible. These might include things like your general health, how well your organs are working, and what other treatments you might have had in the past for your kidney cancer. These specific details would be discussed with you by the study team.
Sometimes, conditions like other serious long-term illnesses or certain previous treatments might mean a person can't join the study, as it could affect their safety or the results of the research. The study team will review all your medical information carefully to decide if this study is right for you.
- Are you 18 years old or older?
- Have you been diagnosed with advanced kidney cancer that has spread?
- Are you generally well enough to participate in a clinical study?
- Are you able to attend regular hospital visits for treatment and check-ups?
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, you would receive the study medicine, PF-08634404, either on its own or in combination with other approved cancer drugs like ipilimumab or axitinib. You would have regular visits to the hospital or clinic for various tests. These tests include physical examinations, blood tests to check your overall health and look for side effects, and scans (like CT scans) to see if your cancer is responding to the treatment.
The frequency of these visits and tests might change over time, being more frequent at the beginning of the study and then perhaps less often if you continue with the treatment. The total duration of your participation would depend on how your cancer responds to the treatment and your general health, but you would continue receiving treatment as long as it is benefiting you and you are tolerating it well. After stopping the treatment, there would likely be follow-up visits to monitor your health.
Potential risks and benefits
Locations (2)
- —Germany
- —Spain
Common questions
What kind of cancer is this study for?
This study is for adults with advanced kidney cancer (renal cell carcinoma) that has spread to other parts of the body.
What is PF-08634404?
PF-08634404 is a new, experimental medicine being tested in this study to see if it can help treat kidney cancer.
Will I receive the new medicine by itself or with other drugs?
You might receive PF-08634404 on its own or in combination with other established anti-cancer drugs like ipilimumab or axitinib, depending on which group you are in.
What are the main things the researchers are looking for?
The main things they are looking for are how safe the medicine is (side effects) and how well it works to shrink or control the cancer.
Can I stop participating in the study at any time?
Yes, you have the right to leave the study at any point, and doing so will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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