An international investigator-led phase III multi arm multi stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse
We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back.
What is this study about?
RAMPART (Renal Adjuvant MultiPle Arm Randomised Trial) is a study looking at the effects of immunotherapy drugs on patients who have recently had a nephrectomy. We aim to find out whether the use of a single immunotherapy drug (Durvalumab) or a combination of two drugs (Durvalumab and Tremelimumab) could delay or prevent the relapse of cancer compared to the current standard of care. The current standard of care is active monitoring which involves observation through radiographic means.
The drugs being tested are immunotherapy drugs and can also be referred to as immune checkpoint inhibitors. They work by helping the patient’s immune system attack their cancer. Durvalumab, an anti-PDL1 drug, is currently being tested in a number of different types of cancers; both as a single therapy and in combination. Tremelimumab, an anti-CTLA4 drug, has been shown to be effective in treating various different types of cancer, especially when used in combination with other cancer treatments.
Around 1750 patients will be recruited onto the study from sites across the UK, Australia, France and the US. Recruitment is predicted to take approximately 5.5 years with the first results from the study expected at 6.5 years into the study. More results will follow thereafter.
Type of study
Who is funding the study?
Astra Zeneca (educational grant), Kidney Cancer UK
When is it taking place?
The study opened in 2018, and is estimated to close in 2040.
Where is it taking place?
Hospitals in the United Kingdom, Australia, France, and the Spain
Who is included?
Patients who have had a recent nephrectomy (partial or radical; between 28 days and 91 days ago) and show no signs of macroscopic residual disease.