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ONO-4538
ONO-4538 is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses.
ONO-4538 is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Melanoma.
At a glance
| Generic name | ONO-4538 |
|---|---|
| Also known as | Nivolumab, Opdivo, nivolumab |
| Sponsor | Ono Pharmaceutical Co. Ltd |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the PD-1 checkpoint, ONO-4538 removes the inhibitory signal that tumors use to evade the immune system. This allows T cells to become reactivated and mount an effective anti-tumor response. The drug is designed to enhance endogenous anti-tumor immunity across multiple cancer types.
Approved indications
- Non-small cell lung cancer
- Gastric cancer
- Melanoma
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
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 |