A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
This research study is about finding new and better ways to treat advanced kidney cancer. We're looking at a new drug called MEDI5752, given together with either Lenvatinib or Axitinib. The main goal is to understand how safe these combinations are, how well people tolerate them, and if they help shrink the cancer or stop it from growing. This is an early-stage study, meaning we're gathering important information about these new treatments to help doctors decide if they could be useful for more people in the future. It's for adults with a specific type of kidney cancer that has spread.
At a glance
What is this study about?
This study is designed to explore new treatment options for people living with advanced kidney cancer, specifically a type called renal cell carcinoma. When cancer is 'advanced', it means it has grown or spread beyond the original site in the kidney.
The researchers are focusing on an experimental drug called MEDI5752. They want to see what happens when MEDI5752 is given alongside another cancer drug, either Lenvatinib or Axitinib. The hope is that combining these drugs might be more effective than current treatments. This is a 'Phase 1' study, which means it's an early step in testing new medicines. The main things researchers want to find out are how safe the drug combinations are, what side effects people might experience, and how well the body handles the drugs. They will also look for early signs of whether the cancer responds to the treatment.
By taking part, you would be helping doctors learn more about these new drug combinations. This information is crucial for deciding if these treatments should be studied further in larger groups of people, potentially leading to new ways to help patients with advanced kidney cancer in the future.
Key takeaways
- This study is testing new drug combinations for advanced kidney cancer.
- It's an early-stage study focusing on safety and how the drugs are tolerated.
- The new drug being studied is MEDI5752, combined with Lenvatinib or Axitinib.
- Adults with a specific type of untreated advanced kidney cancer may be eligible.
- Participation involves regular hospital visits, tests, and taking study medications.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is for adults aged 18 or older who have advanced kidney cancer, specifically a type called clear cell renal cell carcinoma. You must not have received treatment for this advanced kidney cancer before. Your body weight needs to be over 5 stone 7 pounds (35 kg).
To join, doctors will need a sample of your cancer tissue (from a previous biopsy or surgery) to confirm the exact type. You should also be generally well enough to take part in a study, meaning you can carry out most daily activities, and your important organs (like your kidneys and liver) are working properly. If you are female and could become pregnant, you will need to have a negative pregnancy test and use effective contraception during the study.
You cannot join if you've already had certain types of cancer treatments, such as specific immune system drugs (like PD-1, PD-L1, or CTLA-4 inhibitors) or drugs that block blood vessel growth (VEGF inhibitors) for your kidney cancer. Also, if you have certain infections like HIV, hepatitis, or tuberculosis, or a history of organ transplant or serious autoimmune conditions, you wouldn't be able to participate. Your blood pressure also needs to be well-controlled.
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 advanced kidney cancer (renal cell carcinoma)?
- Have you not yet been treated for this advanced kidney cancer?
- Do you feel reasonably well and able to manage daily activities?
- Is your blood pressure generally well-controlled?
- Have you *not* had certain immune or VEGF inhibitor treatments for kidney cancer before?
What does participation involve?
If you decide to take part in this study, you would receive one of the experimental drug combinations. The study would involve regular hospital visits, where you'd have examinations, blood tests, and scans (like CT scans) to check your health and see how the treatment is affecting your cancer. Researchers would also be carefully monitoring for any side effects you might experience.
The drugs would be given for as long as they are helping you and as long as you are tolerating them well. You would have regular check-ups to make sure you're feeling okay and to track your progress. The total duration of your participation in the study, including follow-up after stopping treatment, might vary, but is typically several months to over a year, depending on how you respond to treatment.
Potential risks and benefits
Locations (20)
- Research SiteVerified postcodeWashington D.C., United States
- Research SiteVerified postcodeFort Myers, United States
- Research SiteVerified postcodeSt Louis, United States
- Research SiteVerified postcodeNew York, United States
- Research SiteVerified postcodeCleveland, United States
- Research SiteVerified postcodeHershey, United States
- Research SiteVerified postcodeNashville, United States
- Research SiteVerified postcodeFrankston, Australia
- Research SiteVerified postcodeWaratah, Australia
- Research SiteVerified postcodeVillejuif, France
- Research SiteVerified postcodeBarcelona, Spain
- Research SiteVerified postcodeBarcelona, Spain
Common questions
What is advanced kidney cancer?
Advanced kidney cancer means the cancer has grown or spread beyond the kidney to other parts of the body.
What does 'Phase 1' mean for a study?
Phase 1 is an early stage. It mainly checks how safe a new treatment is and what side effects it might cause, rather than how well it works.
Will I know which combination of drugs I'm getting?
The study aims to see how MEDI5752 works with either Lenvatinib or Axitinib, and the study team will be able to explain how the treatments are assigned.
Do I have to pay to be in the study?
No, all study-related treatments and tests are provided at no cost to you.
What if I change my mind about participating?
You can withdraw from the study at any time, for any reason, without it affecting your 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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