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 Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma
- Conditions
- Interventions
- First Posted Date
- 2016-12-13
- Last Posted Date
- 2022-08-24
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Target Recruit Count
- 144
- Registration Number
- NCT02991482
- Locations
- ๐จ๐ญ
Kantonsspital Aarau, Aarau, Switzerland
๐จ๐ญKantonsspital Winterthur, Winterthur, Switzerland
๐จ๐ญCentre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in NSCLC
- Conditions
- Interventions
- First Posted Date
- 2016-12-09
- Last Posted Date
- 2022-12-19
- Lead Sponsor
- Nathan Pennell, MD, PhD
- Target Recruit Count
- 9
- Registration Number
- NCT02987998
- Locations
- ๐บ๐ธ
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
HDCRT Plus Pembrolizumab in Advanced Malignancies
- Conditions
- Interventions
- First Posted Date
- 2016-12-08
- Last Posted Date
- 2020-12-16
- Lead Sponsor
- James Larner, MD
- Target Recruit Count
- 21
- Registration Number
- NCT02987166
- Locations
- ๐บ๐ธ
University of Virginia, Charlottesville, Virginia, United States
Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2024-07-09
- Lead Sponsor
- HiberCell, Inc.
- Target Recruit Count
- 64
- Registration Number
- NCT02981303
- Locations
- ๐บ๐ธ
John Wayne Cancer Institute, Santa Monica, California, United States
๐บ๐ธArizona Center for Cancer Care, Avondale, Arizona, United States
๐บ๐ธSarah Cannon Research Institute, Nashville, Tennessee, United States
Pilot Study of Pembrolizumab Treatment for Disease Relapse After Allogeneic Stem Cell Transplantation
- Conditions
- Interventions
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2024-04-22
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 12
- Registration Number
- NCT02981914
- Locations
- ๐บ๐ธ
University of Chicago, Chicago, Illinois, United States
Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2021-02-10
- Target Recruit Count
- 17
- Registration Number
- NCT02981524
- Locations
- ๐บ๐ธ
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron
- Conditions
- Interventions
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2022-02-16
- Lead Sponsor
- Aiwu Ruth He, MD
- Target Recruit Count
- 4
- Registration Number
- NCT02982720
- Locations
- ๐บ๐ธ
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)
- Conditions
- Interventions
- First Posted Date
- 2016-11-23
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 111
- Registration Number
- NCT02972034
- Locations
- ๐จ๐ฆ
Merck Canada, Kirkland, Quebec, Canada
๐บ๐ธCall for Information (Investigational Site 0002), Grand Rapids, Michigan, United States
๐บ๐ธCall for Information (Investigational Site 0001), Nashville, Tennessee, United States
Pembrolizumab in Refractory Advanced Esophageal Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-11-23
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 49
- Registration Number
- NCT02971956
- Locations
- ๐บ๐ธ
Massachusetts General Hospital, Boston, Massachusetts, United States
๐บ๐ธBeth Israel Deaconess Medical Center, Boston, Massachusetts, United States
๐บ๐ธDana Farber Cancer Institute, Boston, Massachusetts, United States
Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
- First Posted Date
- 2016-11-23
- Last Posted Date
- 2024-07-17
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 37
- Registration Number
- NCT02971748
- Locations
- ๐บ๐ธ
M D Anderson Cancer Center, Houston, Texas, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.