OncoMatch/Clinical Trials/NCT03288532
Renal Adjuvant MultiPle Arm Randomised Trial
Is NCT03288532 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Durvalumab and Tremelimumab for renal cell carcinoma.
Treatment: Durvalumab · Tremelimumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Performance status
WHO 0–1
Prior therapy
Must have received: nephrectomy
no evidence of residual macroscopic disease on post-operative CT scan after resection of RCC
Cannot have received: anticancer treatment
Exception: nephrectomy
Prior anticancer treatment (other than nephrectomy) for RCC
Lab requirements
Blood counts
Haemoglobin ≥9.0g/dL (transfusions allowed within 2 weeks prior to randomisation); ANC ≥1.5 x 10^9/L (≥1500 per mm3); Platelet count ≥100 x 10^9 (≥100,000 per mm3)
Kidney function
Calculated Creatinine Clearance >40mL/min by Cockcroft Gault formula (using actual body weight)
Liver function
Bilirubin ≤1.5 x ULN (except Gilbert's syndrome, allowed with physician consultation); AST/ALT ≤2.5 x ULN
Cardiac function
QTcF <450 ms on 12-lead ECG (if ≥450 ms, must be confirmed by two additional ECGs)
Adequate normal organ and marrow function; 12-lead ECG on which QTcF must be <450 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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