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Nivolumab and Recombinant Human Hyaluronidase
Nivolumab and Recombinant Human Hyaluronidase is a PD-1 inhibitor with hyaluronidase enzyme Small molecule drug developed by SWOG Cancer Research Network. It is currently in Phase 3 development for Advanced or metastatic solid tumors (investigational combination in phase 3 trials). Also known as: Hyaluronidase-nvhy and Nivolumab, Hyaluronidase/Nivolumab, Nivolumab and Hyaluronidase-nvhy, Nivolumab and rHuPH20.
Nivolumab blocks PD-1 to enhance anti-tumor immunity, while recombinant human hyaluronidase improves drug penetration into tumors by degrading hyaluronic acid in the extracellular matrix.
Nivolumab blocks PD-1 to enhance anti-tumor immunity, while recombinant human hyaluronidase improves drug penetration into tumors by degrading hyaluronic acid in the extracellular matrix. Used for Advanced or metastatic solid tumors (investigational combination in phase 3 trials).
At a glance
| Generic name | Nivolumab and Recombinant Human Hyaluronidase |
|---|---|
| Also known as | Hyaluronidase-nvhy and Nivolumab, Hyaluronidase/Nivolumab, Nivolumab and Hyaluronidase-nvhy, Nivolumab and rHuPH20, Nivolumab/Recombinant Human Hyaluronidase |
| Sponsor | SWOG Cancer Research Network |
| Drug class | PD-1 inhibitor with hyaluronidase enzyme |
| Target | PD-1; hyaluronic acid (via hyaluronidase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab is a PD-1 checkpoint inhibitor that restores T-cell mediated anti-tumor immunity by blocking the PD-1/PD-L1 interaction. The addition of recombinant human hyaluronidase (rHuPH20) degrades hyaluronic acid in the tumor microenvironment, reducing physical barriers and enhancing intratumoral penetration and distribution of nivolumab, potentially improving efficacy.
Approved indications
- Advanced or metastatic solid tumors (investigational combination in phase 3 trials)
Common side effects
- Fatigue
- Immune-related adverse events (irAEs)
- Diarrhea
- Rash
- Pneumonitis
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- 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)
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 and Recombinant Human Hyaluronidase CI brief — competitive landscape report
- Nivolumab and Recombinant Human Hyaluronidase updates RSS · CI watch RSS
- SWOG Cancer Research Network portfolio CI
Frequently asked questions about Nivolumab and Recombinant Human Hyaluronidase
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Related
- Drug class: All PD-1 inhibitor with hyaluronidase enzyme drugs
- Target: All drugs targeting PD-1; hyaluronic acid (via hyaluronidase)
- Manufacturer: SWOG Cancer Research Network — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (investigational combination in phase 3 trials)
- Also known as: Hyaluronidase-nvhy and Nivolumab, Hyaluronidase/Nivolumab, Nivolumab and Hyaluronidase-nvhy, Nivolumab and rHuPH20, Nivolumab/Recombinant Human Hyaluronidase
- Compare: Nivolumab and Recombinant Human Hyaluronidase vs similar drugs
- Pricing: Nivolumab and Recombinant Human Hyaluronidase cost, discount & access