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
- -
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-05-20
- Last Posted Date
- 2024-03-25
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 100
- Registration Number
- NCT02779751
- Locations
- 🇫🇷
Hôpital Arnaud de Villeneuve - CHU Montpellier, Montpellier, Hérault, France
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸University of Colorado School of Medicine, Aurora, Colorado, United States
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-05-20
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 47
- Registration Number
- NCT02778685
- Locations
- 🇺🇸
City of Hope Corona, Corona, California, United States
🇺🇸City of Hope Medical Center, Duarte, California, United States
🇺🇸City of Hope Antelope Valley, Lancaster, California, United States
Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
- First Posted Date
- 2016-05-20
- Last Posted Date
- 2016-06-22
- Lead Sponsor
- Prof. Dr. Matthias Preusser
- Target Recruit Count
- 21
- Registration Number
- NCT02779101
- Locations
- 🇦🇹
Dept of Internal Medicine, Vienna, Austria
Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-05-19
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- Dan Zandberg
- Target Recruit Count
- 80
- Registration Number
- NCT02777385
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery
- Conditions
- Interventions
- First Posted Date
- 2016-05-18
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 57
- Registration Number
- NCT02775851
- Locations
- 🇺🇸
Licking Memorial Hospital, Newark, Ohio, United States
🇺🇸Newark Radiation Oncology, Newark, Ohio, United States
🇺🇸Logan Health Medical Center, Kalispell, Montana, United States
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)
- Conditions
- Interventions
- First Posted Date
- 2016-05-17
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 559
- Registration Number
- NCT02775435
Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
- Conditions
- Interventions
- First Posted Date
- 2016-05-13
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- Northside Hospital, Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT02771197
- Locations
- 🇺🇸
Northside Hospital, Atlanta, Georgia, United States
🇺🇸Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck
- Conditions
- Interventions
- First Posted Date
- 2016-05-11
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Assuntina Sacco, M.D.
- Target Recruit Count
- 27
- Registration Number
- NCT02769520
- Locations
- 🇺🇸
University of California Los Angeles, Torrance, California, United States
🇺🇸UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸University of California San Francisco, San Francisco, California, United States
Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-05-11
- Last Posted Date
- 2023-05-22
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 40
- Registration Number
- NCT02768701
- Locations
- 🇺🇸
George Washington University-Medical Faculty Associates, Washington, District of Columbia, United States
🇺🇸Rex Cancer Center, Raleigh, North Carolina, United States
🇺🇸Cone Health Cancer Center, Greensboro, North Carolina, United States
Phase II: Pembrolizumab/Carboplatin/Taxol in Epithelial Ovary Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-05-10
- Last Posted Date
- 2024-02-26
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 29
- Registration Number
- NCT02766582
- Locations
- 🇺🇸
Medical College of Wisconsin and Froedtert Hospital, Milwaukee, Wisconsin, United States
🇺🇸Cleveland Clinic, Cleveland, Ohio, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.