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Trial Summary

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.



ACTRN/NCT /ethics:


Scientific 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

Sponsor / Cooperative group:


Trial & Patient Characteristics

Cancer TypeKidney
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
Tumour Stream -
Cancer StageAll stages
Anticipated Start Date2018-07-19
Anticipated End Date2034-07-01

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Phone08 7074 2342
Principal InvestigatorProfessor Michael Brown
Recruitment StatusRecruiting