Last reviewed · How we verify
Pembrolizumab IV
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, preventing tumor cells from evading immune attack.
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, preventing tumor cells from evading immune attack. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma.
At a glance
| Generic name | Pembrolizumab IV |
|---|---|
| Also known as | MK-3475, KEYTRUDA®, SCH 900475 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab binds to programmed death receptor 1 (PD-1) on T lymphocytes, blocking interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and antigen-presenting cells. This blockade restores T-cell activation, proliferation, and anti-tumor cytotoxic function, allowing the immune system to recognize and eliminate cancer cells that would otherwise evade immune surveillance.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Urothelial carcinoma
- Gastric cancer
- Cervical cancer
- Renal cell carcinoma
- Hepatocellular carcinoma
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Diarrhea
- Rash
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathy (thyroiditis, adrenalitis)
- Infusion-related reactions
Key clinical trials
- Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (PHASE1)
- Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial (PHASE2)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I) (PHASE1)
- BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma (PHASE1, 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:
- Pembrolizumab IV CI brief — competitive landscape report
- Pembrolizumab IV updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI