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
- -
Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial Cancer
- First Posted Date
- 2023-03-09
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 60
- Registration Number
- NCT05761951
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors
- Conditions
- Well-Differentiated Neuroendocrine CarcinomaHigh Grade Neuroendocrine Carcinoma, Any SiteNeuroendocrine Tumors
- Interventions
- First Posted Date
- 2023-02-27
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 29
- Registration Number
- NCT05746208
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites
- First Posted Date
- 2023-02-27
- Last Posted Date
- 2023-08-24
- Lead Sponsor
- China Medical University Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT05745233
- Locations
- 🇨🇳
China Medical University Hospital, Taichung, Please Select, Taiwan
PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma
- Conditions
- Advanced Head and Neck Squamous Cell Carcinoma
- Interventions
- First Posted Date
- 2023-02-24
- Last Posted Date
- 2023-05-18
- Lead Sponsor
- Canadian Cancer Trials Group
- Registration Number
- NCT05743777
Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Metastatic Triple-Negative Breast CarcinomaRefractory Triple-Negative Breast CarcinomaUnresectable Triple-Negative Breast Carcinoma
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyBiological: PembrolizumabDrug: PropranololOther: Questionnaire Administration
- First Posted Date
- 2023-02-23
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 25
- Registration Number
- NCT05741164
- Locations
- 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
- First Posted Date
- 2023-02-17
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Tango Therapeutics, Inc.
- Target Recruit Count
- 225
- Registration Number
- NCT05732831
- Locations
- 🇺🇸
Stanford University, Palo Alto, California, United States
🇺🇸Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸University Chicago Medicine, Chicago, Illinois, United States
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- First Posted Date
- 2023-02-13
- Last Posted Date
- 2023-02-21
- Lead Sponsor
- Oslo University Hospital
- Target Recruit Count
- 40
- Registration Number
- NCT05725200
- Locations
- 🇳🇴
Oslo University Hospital, Oslo, Norway
Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC
- Conditions
- Head and Neck Squamous Cell CarcinomaResectable Head and Neck Squamous Cell CarcinomaHead and Neck CancerRecurrent Head and Neck Squamous Cell Carcinoma
- Interventions
- First Posted Date
- 2023-02-13
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 28
- Registration Number
- NCT05726370
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Metastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaStage IV Laryngeal Cancer AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Metastatic Head and Neck Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell Carcinoma
- Interventions
- Drug: CarboplatinDrug: CisplatinProcedure: Computed TomographyDrug: FluorouracilProcedure: Magnetic Resonance ImagingDrug: PaclitaxelBiological: PembrolizumabProcedure: Positron Emission TomographyOther: Quality-of-Life AssessmentRadiation: Radiation Therapy
- First Posted Date
- 2023-02-10
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Target Recruit Count
- 290
- Registration Number
- NCT05721755
- Locations
- 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸Carle Physician Group-Effingham, Effingham, Illinois, United States
🇺🇸Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2023-02-10
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 377
- Registration Number
- NCT05722015
- Locations
- 🇭🇺
Törökbálinti Tüdőgyógyintézet ( Site 2105), Törökbálint, Pest, Hungary
🇨🇳Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207), Kaohsiung, Taiwan
🇺🇸St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023), Phoenix, Arizona, United States
Drug Development Updates
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