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Poster display session

2111 - A Phase III, Randomized, Double-Blind, Multicenter Study of Adjuvant Nivolumab vs Placebo in Patients (pts) With High-Risk Invasive Urothelial Carcinoma (UC; CheckMate 274)

Date

10 Sep 2017

Session

Poster display session

Presenters

Dean Bajorin

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

D.F. Bajorin1, M.D. Galsky2, J.E. Gschwend3, Y. Tomita4, A. Azrilevich5, F. Witjes6

Author affiliations

  • 1 Department Of Medicine, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2 Department Of Medicine, Icahn School of Medicine at Mount Sinai, New York/US
  • 3 Dept. Of Urology, Technical University of Munich, Klinikum rechts der Isar, 81675 - Munich/DE
  • 4 Department Of Urology, Niigata University, Niigata/JP
  • 5 Global Clinical Research/oncology, Bristol-Myers Squibb, 08540 - Princeton/US
  • 6 Department Of Urology, Radboud University Medical Center, Nijmegen/NL
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Resources

Abstract 2111

Background

Standard of care for muscle-invasive bladder cancer (predominant form of UC) is cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy + pelvic node dissection or cystectomy + pelvic node dissection alone if cisplatin-ineligible. Some pts undergo surgical resection followed by adjuvant cisplatin-based chemotherapy. Many pts are not candidates for adjuvant chemotherapy or are not treated due to lack of proven survival benefit. UC of the ureter or renal pelvis is typically managed with nephroureterectomy. Despite surgery ± chemotherapy, pts with invasive UC are at high risk of recurrence and death. Based on the efficacy and safety of the programmed death-1 (PD-1) inhibitor nivolumab for metastatic or unresectable UC progressing despite chemotherapy (CheckMate 032 and 275), we are conducting an international phase III study of adjuvant nivolumab vs placebo in pts with invasive UC (originating in bladder, ureter, or renal pelvis) following resection (NCT02632409).

Trial design

Pts must have had radical surgical resection ± cisplatin-based neoadjuvant chemotherapy within the past 120 days and be disease-free (by imaging) ≤4 weeks before randomization. Pts who did not receive cisplatin-based neoadjuvant chemotherapy must be ineligible for or refuse adjuvant cisplatin. Tumor tissue must be provided for biomarker analysis. Pts are ineligible if they had partial cystectomy or partial nephrectomy, or secondary treatment after surgical removal of UC (eg, cisplatin-based adjuvant chemotherapy), prior malignancy within 3 years except those treated with curative intent and in remission, or any condition requiring systemic treatment with immunosuppressants (eg, corticosteroids) within 2 weeks of treatment. Recruitment began in February 2016; target enrollment is ∼640 pts. Co-primary endpoints: Disease-free survival (defined as the time between date of randomization and date of first recurrence or death) in pts with tumors expressing ≥1% PD-ligand 1 and in all randomized pts. Secondary endpoints: Non-urothelial tract recurrence-free survival, disease-specific survival, overall survival.

Clinical trial identification

NCT02632409

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

D. Bajorin: Reports grants from Bristol-Myers Squibb, during the conduct of the study; other from Bristol-Myers Squibb, outside the submitted work. M.D. Galsky: Consultant for Astellas, AstraZeneca, Genentech, Merck, Novartis and hold stock options for Dual Therapeutics. Y. Tomita: Received honoraria from Novartis and Pfizer, have been a consultant for Novartis and Ono, and have received research funding for Astellas, AstraZeneca, Pfizer, and Takeda. A. Azrilevich: Employee for Bristol-Myers Squibb, the sponsor of this study. Salaried and did not receive any particular payment for participation in this abstract. All other authors have declared no conflicts of interest.

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