Activity of Pembrolizumab plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma (REPRINT trial)
This research study, called REPRINT, is investigating a new way to treat two rare types of kidney cancer: Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma. We're combining two existing cancer medicines, Pembrolizumab (also known as Keytruda) and Enfortumab Vedotin. Both medicines are given through a drip (infusion). The main goal of this study is to see how many people experience their tumours shrinking or disappearing after receiving this treatment. We also want to understand if the treatment helps people live longer without their cancer growing, improves overall survival, and how well people tolerate the treatment and any side effects it might cause. This is a Phase II study, which means we are exploring how effective and safe this combination is.
At a glance
What is this study about?
This study, called REPRINT, is looking into treating two types of kidney cancer that are quite rare: Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma. These cancers can be challenging to treat, so doctors are always looking for new and better ways to help patients.
In this study, we are testing a combination of two medicines that are already approved for other cancers: Pembrolizumab, which you might know as Keytruda, and Enfortumab Vedotin. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer cells. Enfortumab Vedotin is a targeted therapy that delivers a powerful anti-cancer drug directly to cancer cells. By using these two medicines together, researchers hope to achieve a stronger effect against these specific kidney cancers.
The main aim of the study is to see how many participants experience their tumours shrinking or disappearing after getting this treatment. This is what doctors call the 'objective response rate.' We will also carefully watch to see how long people live without their cancer getting worse, how long they live overall, and what side effects they might experience. This information will help doctors understand if this combination treatment could be a good option for future patients.
Key takeaways
- REPRINT is a study for rare kidney cancers: Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma.
- It tests a combination of two existing cancer medicines: Pembrolizumab (Keytruda) and Enfortumab Vedotin.
- The main goal is to see if the treatment shrinks tumours.
- Researchers also look at effects on survival and any side effects.
- Participants must be 18 or older with one of the specific kidney cancers.
- Treatment involves intravenous infusions and regular health checks.
Who may be eligible?
To be considered for this study, you would need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Since this study focuses on specific types of kidney cancer, you would need to have a confirmed diagnosis of either Medullary Renal Cell Carcinoma or Collecting Duct Carcinoma. The study team would review your medical records to make sure you meet all the necessary health criteria.
It's important to remember that these are just general guidelines. A doctor and the study team would need to carefully check your full medical history and current health to determine if this study is suitable for you.
- Are you 18 years old or older?
- Have you been diagnosed with Collecting Duct Carcinoma?
- Have you been diagnosed with Medullary Renal Cell Carcinoma?
- Are you able to attend appointments at a hospital or clinic?
- Are you comfortable with receiving intravenous infusions?
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 in this study, you would receive the study medications, Pembrolizumab and Enfortumab Vedotin, through an intravenous drip (into a vein) at a hospital or clinic. The specific schedule for how often and how long you receive these infusions would be carefully explained by the study team.
Throughout the study, you would have regular visits to the clinic. These visits would include physical exams, blood tests, and imaging scans (like CT scans) to monitor your health, see how the treatment is affecting your cancer, and check for any side effects. The study team would explain what each visit involves and how long it might take.
There would also be a follow-up period after you stop receiving treatment. During this time, the study team would continue to monitor your health and gather important information about your long-term well-being. The total length of your participation would depend on how your cancer responds to treatment and your overall health, but the study team would give you an estimated timeframe.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What kind of cancer is this study for?
This study is for two rare types of kidney cancer: Collecting Duct Carcinoma and Medullary Renal Cell Carcinoma.
What medicines are being tested?
We are testing a combination of Pembrolizumab (Keytruda) and Enfortumab Vedotin.
How will I receive the treatment?
Both medicines are given directly into your vein through a drip (infusion).
Why is this study being done?
To see if combining these two medicines can help shrink tumours and improve outcomes for people with these specific kidney cancers.
Who can take part in this study?
Adults aged 18 and over, both men and women, with a confirmed diagnosis of one of these two rare kidney cancers.
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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