RAMPART — Renal Adjuvant MultiPle Arm Randomised Trial — Adjuvant Durvalumab Alone or Combined with Tremelimumab in Resected Primary Renal Cell Carcinoma at Intermediate or High Risk of Relapse

Phase 3 · 2025 · Renal Cell Carcinoma

Design

Investigator-led, international, phase 3 multi-arm multi-stage (MAMS) randomised platform trial. Patients were assigned 3:2:2 to Arm A (active monitoring), Arm B (durvalumab alone for 1 year), or Arm C (durvalumab for 1 year plus tremelimumab given during the first two cycles). 790 patients were enrolled across 80 sites worldwide between October 2018 and June 2023.

Population

Adults with resected primary renal cell carcinoma at intermediate or high risk of relapse after nephrectomy.

Primary Endpoint

disease-free survival (DFS); overall survival (OS) in high-risk patients

Key Result

In the first reported comparison (Arm C vs Arm A, presented at ESMO 2025), adjuvant durvalumab plus tremelimumab significantly improved 3-year disease-free survival versus active monitoring (81% vs 73%), with the benefit concentrated in the higher-risk subgroup (3-year DFS 78% vs 61%; >43% relative reduction in recurrence risk). Safety was consistent with the known checkpoint-inhibitor profile. The durvalumab-monotherapy comparison (Arm B vs Arm A) has not yet been reported — results are expected in 2026.

Guideline Impact

Adjuvant immunotherapy in intermediate/high-risk resected renal cell carcinoma