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

Biomarkers in Urothelial Cancer Patients Treated With Pembrolizumab

Phase 2

Conditions: Transitional Cell Carcinoma of the Bladder
Biomarkers

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-08-28

Last Posted Date: 2021-08-20

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 80

Registration Number: NCT03263039

Locations: 🇳🇱
Erasmus MC, Rotterdam, Netherlands

Pembrolizumab in Biliary Tract Cancer

Phase 2

Completed

Conditions: Biliary Tract Cancer
Metastatic Cancer
Advanced Cancer
Gallbladder Cancer

Interventions: Drug: Pembrolizumab
Drug: Cisplatin
Drug: Gemcitabine

First Posted Date: 2017-08-24

Last Posted Date: 2023-11-03

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 50

Registration Number: NCT03260712

Locations: 🇬🇧
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, United Kingdom
🇪🇸
Hospital Universitario 12 De Octubre, Madrid, Spain
🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom

and more 4 locations

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumors

Interventions: Drug: ASP8374
Drug: Pembrolizumab

First Posted Date: 2017-08-24

Last Posted Date: 2024-11-13

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 169

Registration Number: NCT03260322

Locations: 🇮🇹
Site IT39005, Monza, Italy
🇮🇹
Site IT39011, Negrar, Italy
🇺🇸
University of Kansas Cancer Center, Fairway, Kansas, United States

and more 51 locations

Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

Phase 3

Active, not recruiting

Conditions: Renal Cell Carcinoma (RCC)

Interventions: Drug: Sunitinib
Drug: Pembrolizumab
Drug: Epacadostat
Drug: Pazopanib

First Posted Date: 2017-08-24

Last Posted Date: 2024-04-11

Lead Sponsor: Incyte Corporation

Target Recruit Count: 129

Registration Number: NCT03260894

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇨🇦
Sunnybrook Health Sciences, Odette Cancer Centre, Toronto, Ontario, Canada

and more 137 locations