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PD-1 Inhibitor Pregnancy: Contraindicated — PD-1 pathway critical for fetal immune tolerance; effective contraception during and for 5 months after treatment

Nivolumab (RCC / Urothelial)

Brand names: Opdivo

Adult dose

Dose: 240 mg IV every 2 weeks or 480 mg IV every 4 weeks (monotherapy); 3 mg/kg IV every 3 weeks with ipilimumab 1 mg/kg (combination)
Route: Intravenous infusion over 30 minutes
Frequency: Every 2–4 weeks (monotherapy); every 3 weeks ×4 cycles then 480 mg every 4 weeks (combination)
Max: 480 mg per dose (monotherapy)
mRCC: second-line (CheckMate 025) or first-line with ipilimumab (CheckMate 214); urothelial carcinoma: second-line post-platinum; adjuvant RCC (CheckMate 914)

Paediatric dose

Dose: Not established for GU tumours N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed for GU malignancies in paediatrics

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment for mild-moderate impairment

Paediatric weight-based calculator

Not licensed for GU malignancies in paediatrics

Clinical pearls

  • CheckMate 025 (Motzer et al. NEJM 2015): nivolumab vs everolimus in previously treated mRCC — OS 25.0 vs 19.6 months (HR 0.73); first immunotherapy to show OS benefit in RCC; NICE TA417
  • CheckMate 214 (Motzer et al. NEJM 2018): nivolumab + ipilimumab vs sunitinib in first-line intermediate/poor-risk mRCC — OS 47.0 vs 26.6 months; 4-year OS 55% vs 35%; transformed first-line standard; NICE TA581
  • Response durability: PD-1 inhibitors produce durable complete responses in a proportion of patients — estimated 10-15% of intermediate/poor-risk patients achieve long-term (>4 year) remission; distinct from VEGFR TKIs where disease control is maintained only during treatment
  • irAE management: nivolumab + ipilimumab combination has significantly higher irAE rate than monotherapy (~46% grade 3-4); colitis is most common severe irAE — infliximab 5 mg/kg IV for steroid-refractory colitis (MHRA-endorsed use); permanently discontinue for grade 4 irAEs
  • Adjuvant RCC: CheckMate 914 — nivolumab monotherapy adjuvant for 1 year post-nephrectomy in high-risk localised/locally advanced RCC; NICE TA895 (2023) approved; reduces recurrence risk in high-risk resected disease

Contraindications

  • Active severe autoimmune disease
  • Known hypersensitivity

Side effects

  • Immune-mediated adverse events (colitis, pneumonitis, hepatitis, endocrinopathies, nephritis)
  • Fatigue
  • Rash
  • Nausea
  • Higher irAE rate with nivolumab+ipilimumab combination vs monotherapy

Interactions

  • Corticosteroids — reduce efficacy (prophylactic use); use for irAE management only
  • Live vaccines — avoid

Monitoring

  • TFTs, LFTs, creatinine, FBC (each cycle)
  • Endocrine function (adrenal insufficiency, hypophysitis)
  • GI symptoms (colitis)
  • Respiratory symptoms (pneumonitis)
  • Skin assessment

Reference: BNFc; BNF 90; CheckMate 025 (Motzer et al. NEJM 2015); CheckMate 214 (Motzer et al. NEJM 2018); NICE TA417; NICE TA581; MHRA SPC Opdivo; EAU RCC Guidelines 2024. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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