RAMPART

Kidney — In Follow-up

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.

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

In Follow-up

Protocol Number

ANZUP 1606

Trial Email

rampart.study@sydney.edu.au

Co-ordinating centre

NHMRC Clinical Trials 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).