At a glance
ClinicalIndex Comparison Record- ✓Histologically proven RCC (all cell types eligible except pure oncocytoma, collecting duct, medullary, and transitional cell cancer)
- ✓No evidence of residual macroscopic disease on post-operative CT scan after resection
- ✓Leibovich score 3-11
- ✓Surgery 28-91 days prior to randomisation
- ✕Previous diagnosis of RCC
- ✕Metastatic or macroscopic residual disease
- ✕Positive resection margins after partial nephrectomy
- ✕Single pulmonary nodule ≥5mm without benign diagnosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03288532Phase 3RecruitingUpdate OverdueUpdated 69mo ago · Completion was 24mo agoAn 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
In Brief
A Phase 3 clinical trial evaluating Durvalumab and Tremelimumab for Renal Cell Carcinoma. Currently recruiting, targeting 1,750 participants across 35 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
controlled infusion via an infusion pump into a peripheral or central vein
controlled infusion via an infusion pump into a peripheral or central vein