Drug ยท ICI ยท Anti-PD-1

Nivolumab

Trade name: Opdivo. ATC L01FF01.

Nivolumab is a fully human IgG4 anti-PD-1 monoclonal antibody. In skin oncology its primary roles are adjuvant melanoma stage III/IV (resected), first-line metastatic melanoma (alone or in combination with ipilimumab or relatlimab), and emerging use across tumour types.

CurrentLast reviewed 25 March 2026

Indications (UK skin cancer)

  • Adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic diseaseNICE TA684. Covers resected stage III and IV melanoma. 12 months.
  • Metastatic melanoma monotherapy — first-line, NICE TA384.
  • Nivolumab + ipilimumab — first-line metastatic melanoma, NICE TA400.
  • Nivolumab + relatlimab (fixed-dose combination) — first-line metastatic melanoma, NICE TA950.

Dosing

  • Monotherapy: 240 mg IV every 2 weeks OR 480 mg IV every 4 weeks.
  • Combined with ipilimumab (induction, melanoma): ipilimumab 3 mg/kg + nivolumab 1 mg/kg IV every 3 weeks ร— 4 doses (give nivolumab first, then ipilimumab; separate infusion lines), then nivolumab maintenance 240 mg q2w or 480 mg q4w.
  • Combined with relatlimab: fixed-dose combination 480 mg/160 mg IV every 4 weeks.
  • Adjuvant: 12 months total.

irAEs

See pembrolizumab โ€” equivalent profile. Combination ipi + nivo carries substantially higher grade 3โ€“4 irAE rate (~60% vs ~20% monotherapy).

Practical

  • Baseline FBC, U&E, LFT, TFT, glucose, cortisol, CK, lipase; pregnancy test.
  • Adjuvant nivolumab is well-tolerated; combination ICI requires close monitoring and prompt steroid availability.
  • OTRs: graft-rejection risk โ€” multidisciplinary review.

References

  1. Weber JS et al. Adjuvant nivolumab versus ipilimumab in resected stage III/IV melanoma (CheckMate 238). N Engl J Med; 2017.
  2. Larkin J et al. Five-year survival with combined nivolumab and ipilimumab. N Engl J Med; 2019.
  3. Tawbi HA et al. Relatlimab + nivolumab vs nivolumab in advanced melanoma (RELATIVITY-047). N Engl J Med; 2022.
  4. NICE TA384. Nivolumab for treating advanced (unresectable or metastatic) melanoma. London: NICE; accessed 18 May 2026. NICE TA400. Nivolumab in combination with ipilimumab for treating advanced melanoma. London: NICE; accessed 18 May 2026.
  5. NICE TA684. Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease. London: NICE; accessed 18 May 2026. NICE TA950. Nivolumab-relatlimab for untreated unresectable or metastatic melanoma in people 12 years and over. London: NICE; accessed 18 May 2026.

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