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Nivolumab/rHuPH20
Nivolumab is a PD-1 inhibitor that blocks immune checkpoint signaling, while rHuPH20 is a recombinant human hyaluronidase that enhances subcutaneous drug delivery and bioavailability.
Nivolumab is a PD-1 inhibitor that blocks immune checkpoint signaling, while rHuPH20 is a recombinant human hyaluronidase that enhances subcutaneous drug delivery and bioavailability. Used for Metastatic melanoma, Non-small cell lung cancer, Renal cell carcinoma.
At a glance
| Generic name | Nivolumab/rHuPH20 |
|---|---|
| Also known as | BMS-986298, Opdivo |
| Sponsor | Bristol-Myers Squibb |
| Drug class | PD-1 inhibitor with subcutaneous delivery enhancer |
| Target | PD-1 (programmed death receptor-1) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab binds to programmed death receptor-1 (PD-1) on T cells, preventing interaction with PD-L1 and PD-L2 ligands and thereby restoring anti-tumor immune responses. The addition of rHuPH20 (recombinant human hyaluronidase) temporarily degrades hyaluronic acid in subcutaneous tissue, improving drug diffusion and absorption, allowing for subcutaneous administration instead of intravenous infusion while maintaining or improving systemic exposure.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Squamous cell carcinoma of the head and neck
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pruritus
- Immune-mediated pneumonitis
- Immune-mediated hepatitis
- Immune-mediated colitis
- Injection site reactions
Key clinical trials
- Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer (PHASE3)
- A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (PHASE1, PHASE2)
- A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (PHASE3)
- An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (PHASE1, PHASE2)
- A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (PHASE3)
- A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (PHASE2)
- A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (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:
- Nivolumab/rHuPH20 CI brief — competitive landscape report
- Nivolumab/rHuPH20 updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI