To determine the surgical safety after neo-adjuvant durvalumab +/- tremelimumab for patients with locally advanced renal rell carcinoma (RCC) METHODS: An open-label phase 1b trial of neoadjuvant durvalumab +/- tremelimumab in locally advanced RCC was performed at two sites between 2016-2020 (NCT02762006). Inclusion criteria included clinical stage T2b-4 and/or N1, M0 disease, ECOG 0-1, and adequate organ function. A total of four cohorts were evaluated. In the neoadjuvant setting, cohort 1 received durvalumab (D) x 1, and cohorts 2, 2a, and 3 received D + Tremelimumab (T) x 1 dose. Cohorts 1-2a also received adjuvant therapy. Pre- and post-surgical patient characteristics were evaluated and descriptive statistics are presented.
Twenty-five patients underwent neo-adjuvant therapy prior to radical/partial nephrectomy and twenty-three received adjuvant therapy after surgery. Tumors were surgically complex with the most common RENAL score being 11xh and renal vein thrombus present in 6 patients. Median estimated blood loss was 400cc with 3 patients requiring postoperative transfusion (4 units total). No intraoperative complications occurred. There was note of intraoperative adhesions near the kidney in 4 cases (16%). Three patients required re-admission and 5 Clavien-Dindo complications occurred within 30 days of surgery (2-3b).
Surgery for locally advanced renal cell carcinoma is safe for patients after neoadjuvant durvalumab +/- tremelimumab.
Urology. 2025 May 27 [Epub ahead of print]
Jason M Scovell, Brian I Rini, Venkatesh Krishnamurthi, Jihad Kaouk, Christopher J Weight, Moshe C Ornstein, Georges Pascal-Haber, Mohamed Eltemamy, Shilpa Gupta, Steven C Campbell, Joseph Zabell
Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH., Division of Hematology Oncology, Vanderbilt University Medical Center, Nashville, TN; Vanderbilt-Ingram Cancer Center, Nashville, TN., Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH., Department of Urology, University of Minnesota, Minneapolis, MN. Electronic address: .