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Pembrolizumab with Optional Crossover Period
Pembrolizumab blocks PD-1 on immune cells to release the brakes on anti-tumor immunity, allowing T cells to recognize and attack cancer cells.
Pembrolizumab blocks PD-1 on immune cells to release the brakes on anti-tumor immunity, allowing T cells to recognize and attack cancer cells. Used for Melanoma (advanced or metastatic), Non-small cell lung cancer (advanced or metastatic), Head and neck squamous cell carcinoma.
At a glance
| Generic name | Pembrolizumab with Optional Crossover Period |
|---|---|
| Sponsor | Iovance Biotherapeutics, Inc. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab is a humanized monoclonal antibody that binds to programmed death receptor-1 (PD-1) on T cells, preventing interaction with its ligands PD-L1 and PD-L2 expressed on tumor cells and immune cells. This blockade restores T cell activation, proliferation, and effector function, enabling the immune system to mount an anti-tumor response. The optional crossover period in this trial design allows control-arm patients to receive pembrolizumab if the primary endpoint is met.
Approved indications
- Melanoma (advanced or metastatic)
- Non-small cell lung cancer (advanced or metastatic)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma (relapsed or refractory)
- Urothelial carcinoma (advanced or metastatic)
- Gastric or gastroesophageal junction adenocarcinoma
- Cervical cancer (advanced or recurrent)
- Renal cell carcinoma (advanced)
- Hepatocellular carcinoma
- Microsatellite instability-high or mismatch repair-deficient 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)
- Immune-mediated nephritis
Key clinical trials
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
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