Pembrolizumab
- Generic Name
- Pembrolizumab
- Brand Names
- Keytruda
- Drug Type
- Biotech
- Chemical Formula
- -
- 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)
- Associated Therapies
- -
Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
- First Posted Date
- 2016-01-06
- Last Posted Date
- 2022-03-31
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 159
- Registration Number
- NCT02646748
- Locations
- 🇺🇸
John Wayne Cancer Institute at Providence Saint John's Health Center, Santa Monica, California, United States
🇺🇸Georgetown University Medical Center Lombardi CCC, Washington, District of Columbia, United States
🇺🇸The Center for Cancer and Blood Disorders (RCCA MD LLC-Maryland Vidision), Bethesda, Maryland, United States
Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers
- First Posted Date
- 2015-12-30
- Last Posted Date
- 2021-11-24
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 16
- Registration Number
- NCT02642809
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2015-12-29
- Last Posted Date
- 2024-08-29
- Lead Sponsor
- Trisha Wise-Draper
- Target Recruit Count
- 96
- Registration Number
- NCT02641093
- Locations
- 🇺🇸
Ohio State University, Columbus, Ohio, United States
🇺🇸MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
- Conditions
- Interventions
- First Posted Date
- 2015-12-22
- Last Posted Date
- 2024-07-12
- Lead Sponsor
- Jonathan Trent, MD, PhD
- Target Recruit Count
- 33
- Registration Number
- NCT02636725
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Interventions
- First Posted Date
- 2015-12-22
- Last Posted Date
- 2024-11-27
- Target Recruit Count
- 124
- Registration Number
- NCT02638090
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Pembrolizumab (MK-3475) in MM Patients With Residual Disease
- First Posted Date
- 2015-12-21
- Last Posted Date
- 2020-04-29
- Lead Sponsor
- PETHEMA Foundation
- Target Recruit Count
- 20
- Registration Number
- NCT02636010
- Locations
- 🇪🇸
Hospital Clinic, Barcelona, Spain
🇪🇸Hospital 12 de octubre, MAdrid, Spain
🇪🇸Hospital Germans Trias i Pujol, Badalona, Spain
Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-12-18
- Last Posted Date
- 2021-04-28
- Lead Sponsor
- Linda R Duska
- Target Recruit Count
- 88
- Registration Number
- NCT02635360
- Locations
- 🇺🇸
Washington University, School of Medicine, Saint Louis, Missouri, United States
🇺🇸Levine Cancer Institute, Charlotte, North Carolina, United States
🇺🇸INOVA Fairfax Hospital, Falls Church, Virginia, United States
Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients
- Conditions
- Interventions
- First Posted Date
- 2015-12-16
- Last Posted Date
- 2024-05-30
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 21
- Registration Number
- NCT02632344
- Locations
- 🇺🇸
NorthShore University HealthSystem, Evanston, Illinois, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
- First Posted Date
- 2015-12-11
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1609
- Registration Number
- NCT02628067
- Locations
- 🇺🇸
Call for Information (Investigational Site 0008), New Brunswick, New Jersey, United States
🇦🇺MSD Australia, North Ryde, Australia
🇧🇷MSD Brasil, Sao Paulo, Brazil
Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients
- Conditions
- Interventions
- First Posted Date
- 2015-12-09
- Last Posted Date
- 2017-09-15
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 32
- Registration Number
- NCT02625337
- Locations
- 🇳🇱
Antoni van Leeuwenhoek ziekenhuis, Amsterdam, NH, Netherlands
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.