Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Proffered Paper session 1: GU tumours, non-prostate

LBA67 - Phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients (Pts) with renal cell carcinoma (RCC) undergoing nephrectomy (PROSPER, ECOG-ACRIN EA8143), a National Clinical Trials Network trial


10 Sep 2022


Proffered Paper session 1: GU tumours, non-prostate


Tumour Site

Genitourinary Cancers


Mohamad Allaf


Annals of Oncology (2022) 33 (suppl_7): S808-S869. 10.1016/annonc/annonc1089


M. Allaf1, S.E. Kim2, L.C. Harshman3, D.F. McDermott4, V.A. Master5, S. Signoretti6, S. Cole7, H. Moon8, N. Adra9, E.A. Singer10, J. Gills11, T.K. Choueiri12, B. Leibovich13, M.D. Michaelson14, B. shuch15, P.N. Lara16, D.Y.C. Heng17, A. Kapoor18, M.A. Carducci19, N.B. Haas20

Author affiliations

  • 1 N/a, Johns Hopkins University School of Medicine, 21287 - Boston/US
  • 2 Biostatistics, Dana Farber Cancer Institute, 02215 - Boston/US
  • 3 Oncology, Surface Oncology Inc, 02139 - Cambridge/US
  • 4 Heme/onc Department, Beth Israel Deaconess Medical Center, 02215 - Boston/US
  • 5 Urology, Emory University - Rollins School of Public Health, 30322 - Atlanta/US
  • 6 Pathology, Brigham and Women's Hospital, 2115 - Boston/US
  • 7 Medical Oncology, UTSW - University of Texas Southwestern Medical Center, 75390 - Dallas/US
  • 8 Oncology Department, Kaiser Permanente - Riverside Medical Center, 92505 - Riverside/US
  • 9 Oncology, Indiana University Simon Cancer Center, 46202 - Indianapolis/US
  • 10 Urology, Rutgers Cancer Institute of New Jersey, 08903 - New Brunswick/US
  • 11 Urology, LSU Healthcare Network, Metairie Multispeciality Clinic, 70006 - Metairie/US
  • 12 Medical Oncology Department, Dana Farber Cancer Institute, 02215 - Boston/US
  • 13 Urology, Mayo Clinic, 55905 - Rochester/US
  • 14 Oncology, MGH - Massachusetts General Hospital, 02114 - Boston/US
  • 15 Urology, UCLA - David Geffen School of Medicine, 90095 - Los Angeles/US
  • 16 Oncology, University of California Davis Cancer Center, 95817 - Sacramento/US
  • 17 Oncology Department, Tom Baker Cancer Centre, T2N 4N2 - Calgary/CA
  • 18 Oncology And Urology Dept, St. Joseph's Healthcare Hamilton, ON L8N 4A6 - Hamilton/CA
  • 19 Oncology Department, Johns Hopkins University, 21231 - Baltimore/US
  • 20 Hematology/oncology, Abramson Cancer Center - University of Pennsylvania, 19104 - Philadelphia/US


Login to access the resources on OncologyPRO.

Abstract LBA67


We conducted a phase III randomized open label trial priming the immune system with neoadjuvant nivo prior to nephrectomy followed by adjuvant nivo in pts with high risk RCC compared to surgery alone.


Entry criteria included patients with clinical stage ≥T2 or TanyN+ RCC planned for nephrectomy (partial or radical). Select oligometastatic disease was permitted if the pt could be rendered ‘no evidence of disease’ within 12 weeks of surgery. In the investigational arm, nivo was administered (480mg IV q4 weeks) with 1 dose prior to surgery followed by 9 adjuvant doses. The control arm was surgery followed by surveillance without a placebo. Baseline tumor biopsy was required only in the nivo arm. Primary endpoint was recurrence free survival (RFS) regardless of histology. Secondary endpoints include clear cell RCC RFS, overall survival (OS), and quality of life measures.


Between 2/2017 and 6/2021, 819 pts were randomized to perioperative nivo (n=404) or surgery alone (n=415). Clinical stage at enrollment was 53% cT2, 47% cT3-4, 17% cN1, and 4% cM1; 83% of pts had clear cell RCC. The trial was stopped early by DSMC due to futility. RFS was similar between the arms (HR: 0.97; 95% CI: [0.74 – 1.28]; P1-sided = 0.43). The median RFS was not reached. OS was not mature at the time of analysis but was not statistically different between study arms (HR: 1.48; 95% CI: [0.89 – 2.48]; P1-sided = 0.93). Similar withdrawal rates occurred in both arms, approximately 12% (48/404 patients in nivo arm vs. 50/415 in surgery alone arm). 20% of patients treated with nivo experienced at least one Grade 3-4 AE that could be attributable to nivo, compared with 6% in the control arm. The most common treatment related grade 3-4 AEs were kidney injury (1% vs. 2%), rash (2% vs. 0%), and elevated lipase (4% vs. <1%). There were 15 (4%) deaths from RCC in the nivo arm and 18 (4%) deaths from RCC in the surgery alone arm.


Perioperative nivo did not improve RFS in RCC patients at high risk for recurrence. OS data remains immature but is not statistically different between arms. Subset analyses including risk stratification by pathologic stage are ongoing.

Clinical trial identification

NCT03055013; Study start date: February 2, 2017.

Editorial acknowledgement

Legal entity responsible for the study

This study was conducted by the ECOG-ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs).


National Cancer Institute of the National Institute of Health and the Canadian Cancer Society.


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.