RAMPART

 Kidney — Recruiting

RAMPART
Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer. The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks so that if the cancer does come back further treatment options can be considered as early as possible. Surgery, together with ongoing regular follow-up and observation, is the standard approach for people diagnosed with kidney cancer that has required removal of the kidney (or part of a kidney) by surgery. For some people the cancer may return which is when other treatment is offered. 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.
If you think this trial might be right for you, please ask your doctor.
If you think this trial might be right for you, please ask your doctor.
Trial Title
Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART): 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
Cancer Type
Kidney
Trial Status
Recruiting
Protocol Number
ANZUP 1606
Co-ordinating centre
Study Chair
Professor Ian Davis
Study Objective

The RAMPART platform trial has been designed to evaluate multiple treatments simultaneously, while adapting to a changing landscape as data on different agents and combinations
of agents emerges.
The aims for the initial research comparisons are as follows:
– Does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab increase Disease Free Survival (DFS) compared with active monitoring
(Arm B vs Arm A, and Arms C vs Arm A respectively)?
– Does treatment with either durvalumab alone or a combination of durvalumab and tremelimumab increase Overall Survival (OS) compared with active monitoring in
patients classified as Leibovich high-risk (Arm B vs Arm A, and Arms C vs Arm A respectively)?

Patient Population
Patients who have had their RCC resected and are classified as being at intermediate or high risk of recurrence (Leibovich score 3-11) are eligible for randomisation into RAMPART.
Primary Outcome

– Disease Free Survival (DFS) is defined as the interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases, or death from any cause, whichever occurs first.
– Overall Survival is defined as all-cause mortality, the time from randomisation to death from any cause (including RCC).

Recruitment Target
Australian recruitment target – 200pts. (Total international recruitment 1750pts)
Acknowledgements
Funded by Kidney Cancer UK, University College London and by an educational grant from Astra Zeneca.
Further Information
Participating Centres
NSW
Calvary Mater Newcastle
Concord Repatriation General Hospital
Campbelltown Hospital - South Western Sydney Local Health District

VIC
Box Hill Hospital - Eastern Health
St Vincent's Hospital - Melbourne

QLD
Sunshine Coast University Hospital
Mater Cancer Care Centre, Mater Misericordiae Ltd