Pembrolizumab
- Generic Name
- Pembrolizumab
- Brand Names
- Keytruda
- Drug Type
- Biotech
- CAS Number
- 1374853-91-4
- Unique Ingredient Identifier
- DPT0O3T46P
- Background
Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.
- Indication
Pembrolizumab is indicated for the following conditions:
For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.
- Associated Conditions
- Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
- Conditions
- MelanomaMelanoma Stage IIIMelanoma (Skin)Melanoma Stage IV
- Interventions
- First Posted Date
- 2025-01-13
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- University of California, Irvine
- Target Recruit Count
- 14
- Registration Number
- NCT06771544
- Locations
- 🇺🇸
Chao Family Comprehensive Cancer Center University of California, Irvine, Orange, California, United States
A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
- Conditions
- Non Small Cell Lung Carcinoma
- Interventions
- First Posted Date
- 2025-01-13
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 172
- Registration Number
- NCT06772623
- Locations
- 🇺🇸
Providence - St. Jude Medical Center /ID# 271414, Fullerton, California, United States
🇺🇸FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450, Oxnard, California, United States
🇺🇸Mid Florida Hematology And Oncology Center /ID# 273777, Orange City, Florida, United States
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
- Conditions
- Non-Muscle Invasive Bladder Urothelial CarcinomaStage I Bladder Cancer AJCC v8Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingOther: Questionnaire AdministrationRadiation: Radiation Therapy
- First Posted Date
- 2025-01-13
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 160
- Registration Number
- NCT06770582
- Locations
- 🇺🇸
Shaw Cancer Center, Edwards, Colorado, United States
🇺🇸University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
🇺🇸Louisiana Hematology Oncology Associates LLC, Baton Rouge, Louisiana, United States
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2025-01-10
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Summit Therapeutics
- Target Recruit Count
- 780
- Registration Number
- NCT06767514
- Locations
- 🇺🇸
Clinical Study Site, Webster, Texas, United States
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
- Conditions
- HER2-positive Gastric CancerGastroesophageal Junction Adenocarcinoma
- Interventions
- First Posted Date
- 2025-01-09
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 840
- Registration Number
- NCT06764875
- Locations
- 🇻🇳
Research Site, Vinh, Vietnam
Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial
- Conditions
- Locally Advanced Bladder Urothelial CarcinomaLocally Advanced Renal Pelvis and Ureter Urothelial CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Renal Pelvis and Ureter Urothelial CarcinomaStage III Bladder Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Stage IV Renal Pelvis and Ureter Cancer AJCC v8
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: CystectomyDrug: Enfortumab VedotinProcedure: Local TherapyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Questionnaire AdministrationProcedure: Ureterectomy
- First Posted Date
- 2025-01-08
- Last Posted Date
- 2025-02-24
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 75
- Registration Number
- NCT06764095
- Locations
- 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
- Conditions
- Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell LungCarcinoma, Non-Small-Cell Lung (NSCLC)
- Interventions
- First Posted Date
- 2025-01-03
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 714
- Registration Number
- NCT06758401
- Locations
- 🇺🇸
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
🇺🇸BRCR Global, Plantation, Florida, United States
🇺🇸Hope and Healing Cancer Services, New Lenox, Illinois, United States
A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
- Conditions
- NSCLC
- Interventions
- First Posted Date
- 2025-01-01
- Last Posted Date
- 2025-01-01
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Target Recruit Count
- 464
- Registration Number
- NCT06754644
Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-12-20
- Last Posted Date
- 2025-05-06
- Target Recruit Count
- 318
- Registration Number
- NCT06745882
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
- Conditions
- Melanoma, Cutaneous Malignant
- Interventions
- First Posted Date
- 2024-12-19
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Immatics US, Inc.
- Target Recruit Count
- 360
- Registration Number
- NCT06743126
- Locations
- 🇺🇸
SCRI Oncology Partners, Nashville, Tennessee, United States
🇺🇸UCLA Hematology/Oncology, Los Angeles, California, United States
🇺🇸Honor Health Research Institute, Scottsdale, Arizona, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.