RAMPART Renal Adjuvant MultiPle Arm Randomised Trial


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James Larkin1,Angela Meade2,Tom Powles3,Grant Stewart4,Bhavna Oza2,Laurence Albiges5,Axel Bex6,Hanna Bryant2,Toni Choueiri7,Ian Davis8,Tim Eisen9,Alison Fielding10,Elena Frangou2,Patrick Hanlon10,David Harrison11,Rick Kaplan2,Salena Mulhere10,Paul Nathan12,Brian Rini13,Alastair Ritchie2,Clare Shakeshaft2,Ben Smith2,Martin Stockler14,Max Parmar15
1Royal Marsden Hospital,2MRC CTU at UCL,3St Bartholomew’s Hospital,4University of Cambridge,5Institut Gustave Roussy,6Royal Free Hospital,7Dana-Farber Cancer Institute,8Monash University Eastern Health Clinical School and ANZUP Cancer Trials Group,9AstraZeneca and University of Cambridge,10Patient representative,11University of St Andrews,12Mount Vernon Cancer Centre,13Cleveland Clinic,14University of Sydney,15MCR CTU at UCL

Abstract

Background

30-40% of patients with initially localised Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. To date, results of adjuvant tyrosine-kinase inhibitor trials have been inconclusive, and the current global standard‑of‑care after nephrectomy remains active monitoring. Checkpoint inhibitors are effective in metastatic RCC. RAMPART will investigate checkpoint inhibitors in the adjuvant setting.

Method

RAMPART is an investigator-initiated, international, randomised phase III trial of adjuvant checkpoint inhibitors in patients with resected RCC. The target population is patients with histologically proven RCC (clear cell and non-clear cell), with no residual macroscopic disease, and who are at high or intermediate risk of relapse (Leibovich score 3-11). Participants are randomly assigned (3:2:2) to Arm A - active monitoring (no placebo) for one year, Arm B - durvalumab (PD-L1 inhibitor) 4-weekly for one year; or Arm C - combination therapy with durvalumab 4-weekly for one year plus two doses of tremelimumab (CTLA4 inhibitor). The co-primary outcomes are disease-free survival and overall survival. Secondary outcomes include metastasis-free survival, RCC specific survival, quality of life, preferences, and adverse events. Tumour tissue, blood and urine are collected for analysis (TransRAMPART). RAMPART is an innovative multi-arm multi-stage platform trial, upon which additional research questions may be addressed over time. 

Results

We randomised the first patient in October 2018. By May 2019, we recruited 47 of our target 1750 patients from 24 UK sites, averaging 9 patients per month.  We will open in additional UK sites and imminently in France, Australia and USA.

Conclusion

RAMPART is an international, UK-led trial for RCC at intermediate and high risk of recurrence after surgical excision. The full support of our UK and international collaborators is essential to meet our ambitious accrual target and complete this important trial aimed at optimising adjuvant treatment for renal cancer patients.