Renal Cell Carcinoma Clinical Trial
Official title:
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
RATIONALE: The current global standard of care after nephrectomy for localised RCC therefore
remains active monitoring (i.e., observation by clinical and radiological means). 30-40%
patients with initially localised RCC develop metastatic disease following nephrectomy. Need
for adjuvant therapy is most marked in the high risk population where outcomes are
predictably poor. However, the risk of recurrence in patients who are of intermediate risk of
recurrence is not insignificant. Unfortunately, despite showing efficacy in advanced RCC, the
results in the adjuvant setting, so far, are inconclusive.
AIM: RAMPART is a phase III Multi-Arm Multi-Stage randomised controlled platform trial,
initiated with three arms. The trial is assessing if durvalumab monotherapy or the
combination of durvalumab and tremelimumab can improve Disease Free Survival (DFS) or Overall
Survival (OS) compared to the current global standard-of-care (active monitoring). At the
start of recruitment, patients with Leibovich scores 3 to 11 will be eligible for
randomisation. Accrual of intermediate risk patients (Leibovich scores 3 5) will stop after 3
years or when intermediate risk patients contribute 25% of the total accrual target,
whichever is earlier. Recruitment of patients with Leibovich scores 6 to 11 will continue
until the accrual target is reached.
n/a
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