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RAMPART — Adjuvant durvalumab ± tremelimumab vs active monitoring, resected intermediate/high-risk renal cell carcinoma (RCC)

Abstract: LBA4511 · Session: Genitourinary Cancer (kidney) oral abstract session, ASCO Annual Meeting (May 29 – Jun 2, 2026, Chicago) · Presenter: James M. G. Larkin, MD, PhD, FRCP (The Royal Marsden NHS Foundation Trust / The Institute of Cancer Research, London) · Embargo: ASCO 2026

At a glance

  • Sponsor: Academic / investigator-led — MRC Clinical Trials Unit at UCL, with The Institute of Cancer Research / The Royal Marsden; durvalumab and tremelimumab provided by AstraZeneca
  • PI / presenter: James M. G. Larkin, MD, PhD, FRCP — chief investigator; The Royal Marsden NHS Foundation Trust / Institute of Cancer Research, London
  • NCT ID: NCT03288532
  • Phase: 3 (multi-arm, multi-stage [MAMS])
  • Design: International, randomized, open-label MAMS trial. 790 patients randomized 3:2:2 to durvalumab + tremelimumab, durvalumab monotherapy, or active monitoring after complete resection.
  • N: 790
  • Primary endpoint(s): Disease-free survival (DFS); overall survival (co-primary)
  • Comparator: Active monitoring
  • Indication: Completely resected primary RCC at intermediate or high risk of relapse
  • Line: Adjuvant (post-nephrectomy)

Headline result

Adjuvant durvalumab monotherapy did not significantly improve DFS versus active monitoring: HR 0.74 (95% CI 0.53–1.04; 1-sided P = .041, not meeting the pre-specified significance threshold); 3-year DFS 78% vs 72%. In the durvalumab + tremelimumab arm, DFS was improved — 3-year DFS 81% vs 73% with active monitoring, HR 0.65 (~35% relative reduction in recurrence/death), with the greatest benefit in the highest-risk subgroup (HR 0.52). In the monotherapy higher-risk subgroup HR was 0.77 (95% CI 0.53–1.12; P = .085). Combination therapy carried more toxicity: treatment discontinuation for adverse events 29% (combination) vs 19% (monotherapy); corticosteroid use 43% vs 23%; rare fatal immune-mediated events were reported (2 myasthenia gravis, 1 myocarditis; treatment-related deaths: 2 combination, 1 monotherapy). Patient-reported outcomes (reported separately at ASCO GU 2026) favored active monitoring, with worse fatigue, insomnia, pain and cognitive scores on the combination arm.

Mechanism / class

Durvalumab is an anti–PD-L1 monoclonal antibody; tremelimumab is an anti–CTLA-4 monoclonal antibody. The combination delivers dual immune-checkpoint blockade. Both agents are approved together (with chemotherapy or other regimens) in hepatocellular carcinoma and NSCLC; RAMPART tested whether checkpoint blockade reduces recurrence after curative-intent nephrectomy in RCC. Of note, prior adjuvant PD-1 monotherapy (pembrolizumab, KEYNOTE-564) is already approved in this setting — RAMPART monotherapy did not replicate that DFS benefit.

Discussant takeaway

Not separately captured from available trade-press coverage at time of writing; the kidney-cancer session discussion framed adjuvant immunotherapy selection by relapse risk and the DFS-vs-toxicity/quality-of-life trade-off.

Practice-changing?

No / pending. Durvalumab monotherapy missed its DFS endpoint and is not practice-changing. The durvalumab + tremelimumab arm showed a DFS benefit (HR 0.65; 3-year 81% vs 73%), strongest in highest-risk patients, but with materially worse toxicity and patient-reported quality of life and no mature overall-survival benefit yet — so its role versus the established adjuvant pembrolizumab standard (KEYNOTE-564) remains to be defined.

  • AACR 2026: ../../aacr-2026/index.md
  • Other ASCO 2026 trials: see GU/kidney trials in ./
  • JPM 2026: ../../jpm-2026/index.md (AstraZeneca)

Sources

  • UroToday (ASCO 2026 coverage): https://www.urotoday.com/conference-highlights/asco-2026/asco-2026-kidney-cancer/169399-asco-2026-durvalumab-monotherapy-versus-active-monitoring-for-resected-primary-rcc-in-rampart-an-international-phase-3-randomized-controlled-trial.html
  • CancerNetwork: https://www.cancernetwork.com/view/rampart-trial-does-not-meet-dfs-end-point-in-rcc
  • Targeted Oncology: https://www.targetedonc.com/view/durvalumab-monotherapy-misses-dfs-end-point-in-adjuvant-rcc
  • Renal & Urology News (QoL): https://www.renalandurologynews.com/reports/durvalumab-tremelimumab-improved-dfs-worse-qol-rcc/
  • OncLive: https://www.onclive.com/view/adjuvant-durvalumab-plus-tremelimumab-yields-dfs-advantage-in-resected-rcc
  • GU Oncology Now: https://www.guoncologynow.com/post/rampart-durva-plus-treme-boosts-dfs-in-resected-rcc
  • ICR press release: https://www.icr.ac.uk/about-us/icr-news/detail/combination-immunotherapy-significantly-reduces-kidney-cancer-recurrence-after-surgery
  • ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03288532