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 ...

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
-

ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-12-25
Last Posted Date
2024-04-02
Lead Sponsor
Advaxis, Inc.
Target Recruit Count
50
Registration Number
NCT02325557
Locations
🇺🇸

Recruiting, Providence, Rhode Island, United States

🇺🇸

Recrutiing, Philadelphia, Pennsylvania, United States

🇺🇸

University of Colorado Health Sciences Center (UCHSC), Aurora, Colorado, United States

and more 1 locations

Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer

First Posted Date
2014-12-17
Last Posted Date
2019-10-21
Lead Sponsor
Western Regional Medical Center
Target Recruit Count
16
Registration Number
NCT02318901
Locations
🇺🇸

Western Regional Medical Center/Cancer Treatment Center of America, Goodyear, Arizona, United States

Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer

First Posted Date
2014-12-12
Last Posted Date
2024-02-02
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
51
Registration Number
NCT02316002
Locations
🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas

First Posted Date
2014-12-10
Last Posted Date
2023-10-23
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
32
Registration Number
NCT02313272
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma

First Posted Date
2014-12-03
Last Posted Date
2019-06-20
Lead Sponsor
St. Louis University
Target Recruit Count
10
Registration Number
NCT02306850
Locations
🇺🇸

Saint Louis University Hospital, Saint Louis, Missouri, United States

Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer

First Posted Date
2014-12-02
Last Posted Date
2021-08-13
Lead Sponsor
Craig L Slingluff, Jr
Target Recruit Count
68
Registration Number
NCT02305186
Locations
🇺🇸

Hartford HealthCare, Hartford, Connecticut, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Mayo Clinic Cancer Center, Phoenix, Arizona, United States

and more 3 locations

RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers

First Posted Date
2014-12-01
Last Posted Date
2021-05-12
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
59
Registration Number
NCT02303990
Locations
🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-11-25
Last Posted Date
2020-09-29
Lead Sponsor
Sarcoma Alliance for Research through Collaboration
Target Recruit Count
144
Registration Number
NCT02301039
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 9 locations

Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer

First Posted Date
2014-11-24
Last Posted Date
2024-12-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
78
Registration Number
NCT02298959
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

🇨🇦

University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

🇺🇸

National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States

and more 6 locations

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM

First Posted Date
2014-11-10
Last Posted Date
2024-12-05
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
56
Registration Number
NCT02287428
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

© Copyright 2024. All Rights Reserved by MedPath