Nivolumab (Opdivo) for unresectable or metastatic bladder cancer

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Regimen in use at


Study Evidence Efficacy Pt Population
Sharma et al. 2017 (CheckMate 275) Phase II (RT) 19.6% overall
PD-L1 expression ≥5%: 28.4%
PD-L1 expression ≥1%: 23.8%
PD-L1 expression <1%: 16.1%
Prior treatment with least one platinum-based therapy


  • Nivolumab (Opdivo) 3 mg/kg IV once on day 1
    • The FDA-approved dose which is listed in the package insert is 240 mg IV over 60 minutes once on day 1

14-day cycles


  1. CheckMate 275: Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JÁ, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):312-322. Epub 2017 Jan 25. link to original article contains protocol PubMed