Nivolumab — Drug Monograph
Brand names: Opdivo
Drug class: Checkpoint Inhibitor
Mechanism of Action
Human anti-PD-1 IgG4 monoclonal antibody. Mechanism identical to pembrolizumab: blocks PD-1/PD-L1 interaction to restore T-cell antitumor immunity. Nivolumab is a fully human antibody (vs. humanized pembrolizumab) — clinical significance uncertain. Frequently combined with ipilimumab (dual checkpoint blockade — nivolumab + ipilimumab or "Nivo+Ipi") to produce synergistic, durable responses across multiple tumor types.
FDA Indications
- Melanoma — unresectable/metastatic; adjuvant (resected stage IIB/C/III/IV)
- NSCLC — first-line (with ipilimumab ± chemotherapy); second-line monotherapy
- SCLC — third-line
- RCC — first-line (with ipilimumab); second-line monotherapy
- Classical Hodgkin lymphoma (cHL) — relapsed/refractory post-ASCT
- HNSCC — second-line, post-platinum
- Urothelial carcinoma — second-line
- Colorectal cancer (MSI-H/dMMR) — second-line after prior treatment
- Hepatocellular carcinoma — second-line after sorafenib; first-line (with ipilimumab)
- Gastric/GEJ/esophageal cancer — first-line (with chemotherapy, CPS ≥5)
- Esophageal SCC — first-line (with ipilimumab or chemotherapy)
- Mesothelioma — first-line (with ipilimumab)
- TNBC — early stage neoadjuvant/adjuvant
Common Side Effects
- Fatigue
- Rash, pruritus
- Musculoskeletal pain
- Diarrhea
- Nausea
- Hypothyroidism
Clinical Pearl
Nivolumab + ipilimumab dual checkpoint blockade (nivo+ipi) produces more durable responses than monotherapy but with approximately doubled irAE rates. The most impactful application is RCC (CheckMate 214: 5-year OS 48% vs. 26% for sunitinib) and melanoma (5-year OS ~52% vs. ~44% monotherapy). The mechanism of synergy: PD-1 inhibition removes peripheral exhaustion while CTLA-4 inhibition removes central thymic tolerance — different points in the immune activation cascade. Immune-related adverse…
Related Therapies & Mechanisms
- Pembrolizumab (Keytruda) — Checkpoint Inhibitor · HCC
- Ipilimumab (Yervoy) — Checkpoint Inhibitor · NSCLC
- Bevacizumab (Avastin) — HCC
- Cisplatin (Platinol) — NSCLC