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BMS-936558 (Nivolumab)
Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.
Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells. Used for Metastatic melanoma, Advanced non-small cell lung cancer, Renal cell carcinoma.
At a glance
| Generic name | BMS-936558 (Nivolumab) |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | PD-1 inhibitor |
| Target | PD-1 (Programmed Death Receptor-1) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab is a monoclonal antibody that binds to programmed death receptor-1 (PD-1) on T cells, preventing interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and immune cells. This blockade releases the 'brakes' on the immune system, restoring T-cell proliferation, activation, and anti-tumor function. By reinvigorating exhausted T cells, nivolumab enables durable anti-tumor immunity.
Approved indications
- Metastatic melanoma
- Advanced non-small cell lung cancer
- Renal cell carcinoma
- Classical Hodgkin lymphoma
- Squamous cell carcinoma of the head and neck
- Urothelial carcinoma
- Colorectal cancer (microsatellite instability-high or mismatch repair deficient)
Common side effects
- Fatigue
- Rash
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated pneumonitis
- Immune-mediated hepatitis
- Immune-mediated colitis
- Immune-mediated endocrinopathy (thyroiditis, adrenalitis)
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy (PHASE3)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (PHASE1, PHASE2)
- Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer (PHASE1)
- Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma (PHASE2)
- Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (PHASE1, PHASE2)
- Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BMS-936558 (Nivolumab) CI brief — competitive landscape report
- BMS-936558 (Nivolumab) updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI