Renal Adjuvant MultiPle Arm Randomised Trial: 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
Can taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) prevent or delay kidney cancer coming back?
What is this study about?
RAMPART is a study looking at the effects of immunotherapy drugs on patients who have recently had a kidney surgically removed - a procedure called a nephrectomy. We aim to find out whether using a single immunotherapy drug (Durvalumab) or a combination of two drugs (Durvalumab and Tremelimumab) could delay or prevent the relapse of cancer compared with active monitoring, which involves observation through radiography (e.g. X-rays).
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 750 patients will be recruited onto the study from across the UK, Australia, France and Spain. The first results from the study are expected approximately five and a half years from the start of recruitment in 2018. More results will follow thereafter.
Type of study
Who is funding the study?
When is it taking place?
The study opened in 2018 and is estimated to close in 2029. Patient recruitment closed at the end of June 2023.
Where is it taking place?
Hospitals in the UK, Australia, France, and 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.
Patients with a single fully resected soft tissue metastasis which develops at any organ site between 6-24 months after nephrectomy are also eligible.