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: -

Clinical Trials

Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma

Phase 2

Recruiting

Conditions: Liver Cancer, Pediatric
Liver Cancer
Hepatocellular Carcinoma, Childhood
Fibrolamellar Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-10-22

Last Posted Date: 2024-12-16

Lead Sponsor: Allison O'Neill, MD

Target Recruit Count: 18

Registration Number: NCT04134559

Locations: 🇺🇸
Baylor College of Medicine, Houston, Texas, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸
Cincinnati Children's Medical Center, Cincinnati, Ohio, United States

and more 2 locations

Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

First Posted Date: 2019-10-22

Last Posted Date: 2020-09-04

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Registration Number: NCT04135092

Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma

Early Phase 1

Active, not recruiting

Conditions: Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma

Interventions: Biological: Nivolumab
Biological: Pembrolizumab

First Posted Date: 2019-10-22

Last Posted Date: 2024-12-03

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 10

Registration Number: NCT04134325

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, North Carolina, United States

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 3

Terminated

Conditions: Neoplasms, Head and Neck

Interventions: Drug: feladilimab
Drug: Pembrolizumab
Drug: Placebo

First Posted Date: 2019-10-16

Last Posted Date: 2024-07-10

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 315

Registration Number: NCT04128696

Locations: 🇬🇧
GSK Investigational Site, Sutton, United Kingdom

NovoTTF-200A + Pembrolizumab In Melanoma Brain Metastasis

Phase 1

Not yet recruiting

Conditions: Metastatic Melanoma
Melanoma Brain Metastasis

Interventions: Device: NovoTTF-200A
Drug: Pembrolizumab

First Posted Date: 2019-10-16

Last Posted Date: 2024-11-25

Lead Sponsor: Brown University

Target Recruit Count: 30

Registration Number: NCT04129515

Locations: 🇺🇸
Lifespan Cancer Institute, Providence, Rhode Island, United States

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

Phase 1

Active, not recruiting

Conditions: Glioblastoma

Interventions: Drug: Olaptesed pegol
Drug: Temozolomide (TMZ)
Radiation: Radiotherapy
Drug: Bevacizumab
Drug: Pembrolizumab

First Posted Date: 2019-10-10

Last Posted Date: 2023-06-22

Lead Sponsor: TME Pharma AG

Target Recruit Count: 27

Registration Number: NCT04121455

Locations: 🇩🇪
Klinik und Poliklinik für Neurologie Schwerpunkt Klinische Neuroonkologie, Bonn, Germany
🇩🇪
Klinik für Strahlentherapie und Radioonkologie, Mannheim, Germany
🇩🇪
Klinik für Neurologie, Essen, Germany

and more 2 locations

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Phase 2

Active, not recruiting

Conditions: Solid Tumors

Interventions: Drug: Olaparib
Biological: Pembrolizumab

First Posted Date: 2019-10-10

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 300

Registration Number: NCT04123366

Locations: 🇦🇺
Monash Medical Centre ( Site 2205), Clayton, Victoria, Australia
🇦🇷
CEMIC ( Site 2701), Buenos Aires, Argentina
🇩🇪
Universitaetsklinik Koeln ( Site 0903), Koeln, Nordrhein-Westfalen, Germany

and more 132 locations

Abemaciclib + Pembrolizumab In Glioblastoma

Phase 2

Withdrawn

Conditions: Glioblastoma

Interventions: Drug: Pembrolizumab
Drug: Abemaciclib

First Posted Date: 2019-10-07

Last Posted Date: 2021-12-14

Lead Sponsor: Dana-Farber Cancer Institute

Registration Number: NCT04118036

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States