Pembrolizumab

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

• KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.ICD-10: C43.9

• None. None.contraindicated

Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) MPM: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) cHL or PMBCL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) Urothelial Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) MSI-H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) MSI-H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) HCC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) BTC: 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.2 ) MCC: 200 mg every 3 weeks or 400 mg every 6 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. ( 2.2 ) RCC: 200 mg every 3 weeks or 400 mg every 6 weeks as a single agent in the adjuvant setting, or in the advanced setting with either: axitinib 5 mg orally twice daily or lenvatinib 20 mg orally once daily.

Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue KEYTRUDA based on the severity of reaction. ( 5.2 ) Complications of allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. ( 5.4 ) Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception.

The following clinically significant adverse reactions are described elsewhere in the labeling. Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] . Infusion-related reactions [see Warnings and Precautions (5.2) ]. Most common adverse reactions (reported in ≥20% of patients) were: KEYTRUDA as a single agent: fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism. ( 6.1 ) KEYTRUDA in combination with chemotherapy or chemoradiotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain. ( 6.1 ) KEYTRUDA in combination with chemotherapy and bevacizumab: peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, decreased appetite, pyrexia, epistaxis, decreased white blood cell count, and stomatitis.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. There are no available human data informing the risk of embryo-fetal toxicity. In animal models, the PD-1/PD-L1 signaling pathway is important in the maintenance of pregnancy through induction of maternal immune tolerance to fetal tissue (see Data ) . Human IgG4 (immunoglobulins) are known to cross the placenta; therefore, pembrolizumab has the potential to be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with KEYTRUDA to evaluate its effect on reproduction and fetal development. A literature-based assessment of the effects of the PD-1 pathway on reproduction demonstrated that a central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.

Metabolism

The pharmacokinetics (PK) of pembrolizumab was characterized using a population PK analysis with concentration data collected from 2993 patients with various cancers who received pembrolizumab doses of 1 to 10 mg/kg every 2 weeks, 2 to 10 mg/kg every 3 weeks, or 200 mg every 3 weeks. Steady-state concentrations of pembrolizumab were reached by 16 weeks of repeated dosing with an every 3-week regimen and the systemic accumulation was 2.1-fold.

• Sep 4, 2014BLABLA125514Merck Sharp Dohme
• Sep 19, 2025BLABLA761467Merck Sharp Dohme

1. 1Malignant Neoplasm Progression11,56212%
2. 2Death5,7185.7%
3. 3Diarrhoea5,4875.5%
4. 4Fatigue4,9284.9%
5. 5Off Label Use4,6234.6%
6. 6Pyrexia3,7453.7%
7. 7Rash3,5543.5%
8. 8Product Use In Unapproved Indication3,4683.5%
9. 9Nausea3,4493.4%
10. 10Decreased Appetite3,2163.2%
11. 11Hypertension3,1033.1%
12. 12Hypothyroidism2,7992.8%
13. 13Asthenia2,6882.7%
14. 14Drug Ineffective2,4982.5%
15. 15Product Use Issue2,4942.5%

The 10 most recently updated of 2,884 ClinicalTrials.gov registrations naming Pembrolizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
  Recruiting · Phase 2 · Interventional · 130 enrolled · Merck Sharp & Dohme LLC
  NCT07252739updated 2026-06-12
• A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
  Recruiting · Phase 1 · Phase 2 · Interventional · 230 enrolled · Merck Sharp & Dohme LLC
  NCT05319730updated 2026-06-12
• Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)
  Recruiting · Phase 2 · Interventional · 10 enrolled · M.D. Anderson Cancer Center
  NCT07187778updated 2026-06-12
• A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
  Not yet recruiting · Phase 3 · Interventional · 400 enrolled · Hoffmann-La Roche
  NCT07541170updated 2026-06-12
• Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
  Recruiting · Phase 1 · Phase 2 · Interventional · 298 enrolled · Merck Sharp & Dohme LLC
  NCT06780111updated 2026-06-12
• Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
  Active not recruiting · Phase 3 · Interventional · 739 enrolled · National Cancer Institute (NCI)
  NCT03244384updated 2026-06-12
• A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
  Terminated · Phase 1 · Interventional · 132 enrolled · Vividion Therapeutics, Inc.
  NCT06188208updated 2026-06-12
• A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
  Active not recruiting · Observational · 1,000 enrolled · Harbin Medical University
  NCT07645209updated 2026-06-12
• Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
  Recruiting · Phase 3 · Interventional · 3,500 enrolled · Merck Sharp & Dohme LLC
  NCT03486873updated 2026-06-12
• Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
  Recruiting · Phase 3 · Interventional · 1,210 enrolled · National Cancer Institute (NCI)
  NCT04267848updated 2026-06-12

Frequently asked questions

How does Pembrolizumab work?

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

What is Pembrolizumab used for?

According to FDA labeling, Pembrolizumab carries indications including: KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pembrolizumab?

Pembrolizumab is classified as PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors, Programmed Death Receptor-1 Blocking Antibody, Programmed Death Receptor-1-directed Antibody Interactions, Cellular Proliferation Alteration, Decreased Cytokine Production.

What are the brand names for Pembrolizumab?

Pembrolizumab is marketed under brand names including Keytruda, Keytruda Qlex.

What are the contraindications for Pembrolizumab?

Pembrolizumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.