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
- -
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
- Conditions
- Interventions
- First Posted Date
- 2016-11-08
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 46
- Registration Number
- NCT02957968
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸University of Virginia, Charlottesville, Virginia, United States
🇺🇸St. Elizabeth Healthcare, Edgewood, Kentucky, United States
Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-11-04
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- Joel Neal
- Target Recruit Count
- 25
- Registration Number
- NCT02955758
- Locations
- 🇺🇸
Stanford University, School of Medicine, Palo Alto, California, United States
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-11-04
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 1155
- Registration Number
- NCT02954874
- Locations
- 🇺🇸
Southern Cancer Center PC-Daphne, Daphne, Alabama, United States
🇺🇸Southern Cancer Center PC-Mobile, Mobile, Alabama, United States
🇺🇸Southern Cancer Center PC-Providence, Mobile, Alabama, United States
Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-11-03
- Last Posted Date
- 2023-03-16
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 37
- Registration Number
- NCT02954536
- Locations
- 🇺🇸
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors
- First Posted Date
- 2016-11-02
- Last Posted Date
- 2019-07-19
- Lead Sponsor
- Seagen Inc.
- Target Recruit Count
- 47
- Registration Number
- NCT02952989
- Locations
- 🇺🇸
University of Colorado Hospital / University of Colorado, Aurora, Colorado, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
A Study of Pembrolizumab in Patients With Neuroendocrine Tumors
- First Posted Date
- 2016-10-20
- Last Posted Date
- 2021-03-09
- Lead Sponsor
- Fox Chase Cancer Center
- Target Recruit Count
- 21
- Registration Number
- NCT02939651
- Locations
- 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸MD Anderson Cancer Center, Houston, Texas, United States
Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents
- Conditions
- Interventions
- First Posted Date
- 2016-10-18
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 28
- Registration Number
- NCT02936752
- Locations
- 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸University of Kansas Clinical Research Center, Fairway, Kansas, United States
🇺🇸Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
- First Posted Date
- 2016-10-14
- Last Posted Date
- 2022-01-26
- Lead Sponsor
- Targovax ASA
- Target Recruit Count
- 6
- Registration Number
- NCT02933944
- Locations
- 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Australia
🇦🇺Royal Brisbane & Women's Hospital (RBWH), Brisbane, Australia
🇳🇿Christchurch Hospital, Christchurch, New Zealand
Ph 1B B-701 in Combination With Pembrolizumab in Metastatic Transitional Cell Carcinoma of the Urothelial Tract
- First Posted Date
- 2016-10-06
- Last Posted Date
- 2017-06-27
- Lead Sponsor
- Mark Pomerantz, MD
- Target Recruit Count
- 1
- Registration Number
- NCT02925533
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
The Drug Rediscovery Protocol (DRUP Trial)
- Conditions
- Interventions
- Drug: PanitumumabDrug: OlaparibDrug: CrizotinibDrug: ErlotinibDrug: AlectinibDrug: Ipilimumab and nivolumabDrug: SunitinibDrug: Trastuzumab and Pertuzumab (combination treatment)Drug: Vemurafenib and Cobimetinib (combination treatment)Drug: NivolumabDrug: Dabrafenib and trametinibDrug: SelpercatinibDrug: TepotinibDrug: AbemaciclibDrug: ErdafitinibDrug: Atezolizumab and BevacizumabDrug: DacomitinibDrug: DabrafenibDrug: NilotinibDrug: TrametinibDrug: VismodegibDrug: RegorafenibDrug: AfatinibDrug: RibociclibDrug: LenvatinibDrug: PembrolizumabDrug: DurvalumabDrug: RucaparibDrug: AxitinibDrug: PalbociclibDrug: CabozantinibDrug: EntrectinibDrug: TalazoparibDrug: LorlatinibDrug: AlpelisibDrug: NiraparibDrug: Pemigatinib
- First Posted Date
- 2016-10-05
- Last Posted Date
- 2024-01-24
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 1550
- Registration Number
- NCT02925234
- Locations
- 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱Amsterdam UMC, locatie AMC, Amsterdam, Netherlands
Drug Development Updates
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