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Nivolumab or pembrolizumab
These drugs block the PD-1 checkpoint protein on immune cells, allowing the immune system to recognize and attack cancer cells.
These drugs block the PD-1 checkpoint protein on immune cells, allowing the immune system to recognize and attack cancer cells. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Renal cell carcinoma.
At a glance
| Generic name | Nivolumab or pembrolizumab |
|---|---|
| Also known as | Immune checkpoint inhibitors, Opdivo and Keytruda |
| Sponsor | Asan Medical Center |
| Drug class | PD-1 inhibitor |
| Target | PD-1 (Programmed Death-1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab and pembrolizumab are monoclonal antibodies that bind to programmed death receptor-1 (PD-1) on T cells, preventing interaction with PD-L1 and PD-L2 ligands on tumor cells. This blockade releases the 'brakes' on the immune system, restoring T-cell proliferation, activation, and anti-tumor function. By reinvigorating exhausted T cells, these drugs enable durable anti-tumor immunity across multiple cancer types.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Gastric cancer
- Colorectal cancer (microsatellite instability-high or mismatch repair-deficient)
Common side effects
- Fatigue
- Pruritus
- Rash
- Diarrhea
- Nausea
- Immune-related pneumonitis
- Immune-related hepatitis
- Immune-related colitis
- Immune-related thyroiditis
Key clinical trials
- Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (PHASE2)
- Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer (PHASE2)
- Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (NA)
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma (PHASE1)
- SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety (PHASE2)
- Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial (PHASE2)
- Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (PHASE1)
- Drug Screening Using Novel IMD in Renal Cell Carcinoma (PHASE1)
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 or pembrolizumab CI brief — competitive landscape report
- Nivolumab or pembrolizumab updates RSS · CI watch RSS
- Asan Medical Center portfolio CI