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
-

Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-09-11
Last Posted Date
2023-02-16
Lead Sponsor
Celgene
Target Recruit Count
100
Registration Number
NCT02546986
Locations
πŸ‡ΊπŸ‡Έ

Palo Verde Hematology Oncology, Glendale, Arizona, United States

πŸ‡ΊπŸ‡Έ

UCLA Hematology Oncology, Los Angeles, California, United States

πŸ‡ΊπŸ‡Έ

University Cancer and Blood Center, LLC, Athens, Georgia, United States

and more 30 locations

GSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-08-19
Last Posted Date
2021-05-18
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
141
Registration Number
NCT02528357
Locations
πŸ‡³πŸ‡±

GSK Investigational Site, Amsterdam, Netherlands

A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-08-13
Last Posted Date
2024-10-08
Lead Sponsor
EDDC (Experimental Drug Development Centre), A*STAR Research Entities
Target Recruit Count
89
Registration Number
NCT02521844
Locations
πŸ‡ΊπŸ‡Έ

University of Arizona Cancer Center, 3838 N. Campbell Avenue, RM 2111, Site 203, Tucson, Arizona, United States

πŸ‡ΈπŸ‡¬

National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Site 101, Singapore, Singapore

πŸ‡ΈπŸ‡¬

National Cancer Centre Singapore, 11 Hospital Drive, Site 102, Singapore, Singapore

and more 8 locations

Safety Study of a Helper Peptide Vaccine Plus Pembrolizumab

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-08-04
Last Posted Date
2023-08-25
Lead Sponsor
Craig L Slingluff, Jr
Target Recruit Count
22
Registration Number
NCT02515227
Locations
πŸ‡ΊπŸ‡Έ

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-07-31
Last Posted Date
2022-05-05
Lead Sponsor
Eisai Inc.
Target Recruit Count
258
Registration Number
NCT02513472
Locations
πŸ‡ΊπŸ‡Έ

Facility #2, San Antonio, Texas, United States

πŸ‡ΊπŸ‡Έ

Facility #1, Madison, Wisconsin, United States

Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

First Posted Date
2015-07-29
Last Posted Date
2019-07-01
Lead Sponsor
Pfizer
Target Recruit Count
9
Registration Number
NCT02511184
Locations
πŸ‡ΊπŸ‡Έ

City of Hope National Medical Center, Duarte, California, United States

πŸ‡ΊπŸ‡Έ

Emory University Hospital, Atlanta, Georgia, United States

πŸ‡ΊπŸ‡Έ

University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 11 locations

Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

First Posted Date
2015-07-28
Last Posted Date
2024-08-06
Lead Sponsor
Amgen
Target Recruit Count
127
Registration Number
NCT02509507
Locations
πŸ‡ΊπŸ‡Έ

HonorHealth Research Institute, Scottsdale, Arizona, United States

πŸ‡ΊπŸ‡Έ

University of California Los Angeles, Santa Monica, California, United States

πŸ‡ΊπŸ‡Έ

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 29 locations
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