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Placebo to Pembrolizumab
Placebo to Pembrolizumab is a PD-1 inhibitor Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma. Also known as: Normal Saline or Dextrose solution.
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, allowing the immune system to recognize and attack cancer cells.
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, allowing the immune system to recognize and attack cancer cells. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma.
At a glance
| Generic name | Placebo to Pembrolizumab |
|---|---|
| Also known as | Normal Saline or Dextrose solution |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab binds to programmed death receptor-1 (PD-1) on T lymphocytes, preventing interaction with its ligands (PD-L1 and PD-L2) on tumor cells and antigen-presenting cells. This blockade releases the 'brakes' on T-cell-mediated immunity, restoring anti-tumor immune responses. The drug is being evaluated in this Phase 3 trial as a comparison to placebo control.
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
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Diarrhea
- Rash
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathy
Key clinical trials
- A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010) (PHASE3)
- Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer (PHASE3)
- 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)
- A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer (PHASE3)
- A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) (PHASE2)
- A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) (PHASE3)
- A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) (PHASE3)
- Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo to Pembrolizumab CI brief — competitive landscape report
- Placebo to Pembrolizumab updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Placebo to Pembrolizumab
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic melanoma
- Indication: Drugs for Non-small cell lung cancer (NSCLC)
- Indication: Drugs for Head and neck squamous cell carcinoma
- Also known as: Normal Saline or Dextrose solution
- Compare: Placebo to Pembrolizumab vs similar drugs
- Pricing: Placebo to Pembrolizumab cost, discount & access