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 RGX-104 in Patients With Advanced Lung & Endometrial Cancer
- First Posted Date
- 2016-10-04
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- Inspirna, Inc.
- Target Recruit Count
- 146
- Registration Number
- NCT02922764
- Locations
- 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
🇺🇸Sarah Cannon Research Institute, Denver, Colorado, United States
Pembrolizumab in Metastatic Anal Cancer
- First Posted Date
- 2016-09-30
- Last Posted Date
- 2023-06-12
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 38
- Registration Number
- NCT02919969
- Locations
- 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Perioperative Chemo and Pembrolizumab in Gastric Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-09-28
- Last Posted Date
- 2024-02-15
- Lead Sponsor
- Gulam Manji
- Target Recruit Count
- 49
- Registration Number
- NCT02918162
- Locations
- 🇺🇸
Haesong Park, Saint Louis, Missouri, United States
🇺🇸Weill Cornell Medical College/ NewYork-Presbyterian, New York, New York, United States
🇺🇸Brown University, Providence, Rhode Island, United States
Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- First Posted Date
- 2016-09-21
- Last Posted Date
- 2022-01-25
- Lead Sponsor
- Syndax Pharmaceuticals
- Target Recruit Count
- 30
- Registration Number
- NCT02909452
- Locations
- 🇺🇸
The START Center for Cancer Care, San Antonio, Texas, United States
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
- First Posted Date
- 2016-09-21
- Last Posted Date
- 2023-03-02
- Lead Sponsor
- Royal Free Hospital NHS Foundation Trust
- Target Recruit Count
- 25
- Registration Number
- NCT02909348
- Locations
- 🇬🇧
The Royal Cornwall Hospital, Treliske, Truro, United Kingdom
🇬🇧Royal Free London NHS Foundation Trust, London, United Kingdom
Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM)
- Conditions
- Interventions
- First Posted Date
- 2016-09-20
- Last Posted Date
- 2023-08-22
- Lead Sponsor
- Hackensack Meridian Health
- Target Recruit Count
- 12
- Registration Number
- NCT02906332
- Locations
- 🇺🇸
John Theurer Cancer Center-Hackensack Meridian Health, Hackensack, New Jersey, United States
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
- First Posted Date
- 2016-09-16
- Last Posted Date
- 2023-02-24
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 260
- Registration Number
- NCT02903914
- Locations
- 🇺🇸
Johns Hopkins, Baltimore, Maryland, United States
🇺🇸BIDMC, Boston, Massachusetts, United States
🇺🇸MD Anderson, Houston, Texas, United States
JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2016-09-16
- Last Posted Date
- 2023-07-03
- Lead Sponsor
- Jounce Therapeutics, Inc.
- Target Recruit Count
- 242
- Registration Number
- NCT02904226
- Locations
- 🇺🇸
The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Pembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-09-15
- Last Posted Date
- 2021-04-06
- Lead Sponsor
- Yonsei University
- Target Recruit Count
- 41
- Registration Number
- NCT02901301
- Locations
- 🇰🇷
Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of
Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
- Conditions
- Interventions
- First Posted Date
- 2016-09-15
- Last Posted Date
- 2021-02-16
- Lead Sponsor
- Prof. Dr. med. Dirk Schadendorf
- Target Recruit Count
- 16
- Registration Number
- NCT02902042
- Locations
- 🇩🇪
University Hospital Essen, Department of Dermatology, Skin Cancer Center, Essen, North Rhine-Westphalia, Germany
🇩🇪HELIOS Klinikum Krefeld, Krefeld, North Rhine-Westphalia, Germany
🇩🇪Universitätsklinikum Gießen und Marburg GmbH, Klinik für Dermatologie und Allergologie, Gießen, Hessen, Germany
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.