Nivolumab in all diseases

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Bladder cancer

Source: Nivolumab (Opdivo) for unresectable or metastatic bladder cancer


Study Evidence Efficacy Pt Population
Sharma et al. 2017 (CheckMate 275) Phase 2 (RT) 19.6% overall
PD-L1 expression ≥5%: 28.4%
PD-L1 expression ≥1%: 23.8%
PD-L1 expression less than 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 dosing details in abstract PubMed


Source: Nivolumab (Opdivo) for melanoma, adjuvant


Study Evidence Comparator Efficacy 12-month recurrence-free survival (RFS) Comparator RFS
Weber et al. 2017 (Checkmate 238) Phase 3 (E-RT-switch-ic) Ipilimumab Superior RFS 70.5% overall
Stage IIIB or IIIC: 72.3% (95% CI, 67.4 to 76.7)
Stage IV: 63.0% (95% CI, 51.6 to 72.5)
60.8% overall
Stage IIIB or IIIC: 61.6% (95% CI, 56.3 to 66.5)
Stage IV: 57.5% (95% CI, 46 to 67.4)

Preceding treatment

  • Complete resection of stage IIIB, IIIC, or IV melanoma


14-day cycle for up to 26 cycles (1 year)


  1. CheckMate 238: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbé C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA1; CheckMate 238 Collaborators. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. Epub 2017 Sep 10. link to original article contains dosing details in manuscript PubMed