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PROSPER EA8143

Needs review

Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143)

Phase 3N = 819NCT03055013

Population
Previously untreated clinical stage T2 or greater or Tany N+ renal cell carcinoma of clear cell or non-clear cell histology planned for partial or radical nephrectomy, ECOG performance status 0-1; selected patients with oligometastatic disease who were disease free within 12 weeks of surgery were eligible.
Design
Open-label, randomised (1:1) phase 3 trial at 183 community and academic sites in the USA and Canada, February 2017 to June 2021. Nivolumab 480 mg before surgery followed by nine adjuvant doses plus surgery, versus surgery only followed by surveillance. Primary endpoint investigator-reviewed recurrence-free survival. The Data and Safety Monitoring Committee stopped the trial at a planned interim analysis (25 March 2022) because of futility.
Primary endpoint
RFS
Arms
  • Nivolumab plus surgery (experimental, n = 404): Nivolumab 480 mg before surgery, followed by nine adjuvant doses
  • Surgery only (control, n = 415): Surgery followed by surveillance
People
Allaf ME, ECOG-ACRIN Cancer Research Group
RFSHR 0.94 (95% CI 0.74–1.21)
Show the numbers
Results reported for PROSPER EA8143
EndpointAnalysisNivolumab plus surgerySurgery onlyEffect
RFSPatients with renal cell carcinoma (381 nivolumab, 399 surgery only) of 819 randomisedInvestigator-reviewed recurrence-free survival.long term-updateAllaf 2024——HR 0.94 (95% CI 0.74–1.21)P=0.32One-sided p-value. Recurrence-free survival events: 125 (33%) of 381 with nivolumab and 133 (33%) of 399 with surgery only. Median follow-up 30.4 months (nivolumab) and 30.1 months (surgery only). Grade 3-5 adverse events of any cause: 177 (48%) of 366 vs 93 (24%) of 387 treated. Reported at the data cutoff of 24 May 2023, after the Data and Safety Monitoring Committee stopped the trial for futility at a planned interim analysis (25 March 2022). A Lancet Oncology correction to this paper exists (2025) and could not be read: the published abstract values above are unconfirmed against it.
Results reported for PROSPER EA8143
EndpointAnalysisNivolumab plus surgerySurgery onlyEffect
RFSPatients with renal cell carcinoma (381 nivolumab, 399 surgery only) of 819 randomisedInvestigator-reviewed recurrence-free survival.long term-updateAllaf 2024——HR 0.94 (95% CI 0.74–1.21)P=0.32One-sided p-value. Recurrence-free survival events: 125 (33%) of 381 with nivolumab and 133 (33%) of 399 with surgery only. Median follow-up 30.4 months (nivolumab) and 30.1 months (surgery only). Grade 3-5 adverse events of any cause: 177 (48%) of 366 vs 93 (24%) of 387 treated. Reported at the data cutoff of 24 May 2023, after the Data and Safety Monitoring Committee stopped the trial for futility at a planned interim analysis (25 March 2022). A Lancet Oncology correction to this paper exists (2025) and could not be read: the published abstract values above are unconfirmed against it.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS0.940.74–1.21
Primary publication: Allaf ME, Kim SE, Master V, McDermott DF, Harshman LC, Cole SM, et al. Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study. Lancet Oncol. 2024;25(8):1038-1052. PubMedDOI

Appears in

Sources

  1. Allaf ME, Kim SE, Master V, McDermott DF, Harshman LC, Cole SM, et al. Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study. Lancet Oncol. 2024;25(8):1038-1052.

    PubMedDOI