MedPath

Pembrolizumab

Generic Name
Pembrolizumab
Brand Names
Keytruda
Drug Type
Biotech
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)

A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)

Phase 1
Completed
Conditions
Advanced Solid Tumors
Interventions
First Posted Date
2014-07-02
Last Posted Date
2019-02-08
Lead Sponsor
Pfizer
Target Recruit Count
23
Registration Number
NCT02179918
Locations
🇺🇸

Research Administration Office, Los Angeles, California, United States

🇺🇸

Ronald Reagan UCLA Medical Center, Drug Information Center, Los Angeles, California, United States

🇺🇸

UCLA Hematology-Oncology Clinic, Los Angeles, California, United States

and more 6 locations

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Phase 1
Completed
Conditions
Microsatellite-instability (MSI) High Colorectal Cancer (CRC)
Head and Neck Cancer
Melanoma
Endometrial Cancer
Lung Cancer
Renal Cell Carcinoma (RCC)
Bladder Cancer
Gastric Cancer
Ovarian Cancer
Lymphoma
Interventions
First Posted Date
2014-07-01
Last Posted Date
2022-02-14
Lead Sponsor
Incyte Corporation
Target Recruit Count
444
Registration Number
NCT02178722
Locations
🇺🇸

University of Connecticut Health Center Carole And Ray Neag Comprehensive Cancer Center, Farmington, Connecticut, United States

🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

Greater Baltimore Cancer Center, Baltimore, Maryland, United States

and more 21 locations

A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Phase 1
Completed
Conditions
Renal Cell Carcinoma
Interventions
First Posted Date
2014-05-08
Last Posted Date
2021-07-28
Lead Sponsor
Pfizer
Target Recruit Count
52
Registration Number
NCT02133742
Locations
🇺🇸

Brigham & Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

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

and more 16 locations

Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2014-05-02
Last Posted Date
2019-02-15
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
58
Registration Number
NCT02129556
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

🇧🇪

Jules Bordet Institute, Brussels, Belgium

🇧🇪

CHU Sart Tilman, Liège, Belgium

and more 8 locations

Treatment of Advanced Melanoma With MK-3475 and Peginterferon

Phase 1
Completed
Conditions
Melanoma
Interventions
First Posted Date
2014-04-11
Last Posted Date
2021-05-05
Lead Sponsor
Hassane M. Zarour, MD
Target Recruit Count
43
Registration Number
NCT02112032
Locations
🇺🇸

Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

MK-3475 in Melanoma and NSCLC Patients With Brain Metastases

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Brain Metastases
Melanoma
Interventions
First Posted Date
2014-03-12
Last Posted Date
2021-03-24
Lead Sponsor
Yale University
Target Recruit Count
65
Registration Number
NCT02085070
Locations
🇺🇸

Smilow Cancer Center at Yale New Haven Hospital, New Haven, Connecticut, United States

A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)

Phase 1
Completed
Conditions
Carcinoma, Non-small Cell Lung
Interventions
First Posted Date
2014-03-06
Last Posted Date
2020-09-11
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
142
Registration Number
NCT02079636
Locations
🇺🇸

Highlands Oncology Group, Fayetteville, Arkansas, United States

🇺🇸

Indiana Cancer Pavilion, Indianapolis, Indiana, United States

🇺🇸

The West Clinic, Germantown, Tennessee, United States

and more 7 locations

Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

Phase 1
Completed
Conditions
Metastatic Melanoma
Stage III Melanoma
Stage IV Melanoma
Interventions
First Posted Date
2014-02-27
Last Posted Date
2020-06-05
Lead Sponsor
NewLink Genetics Corporation
Target Recruit Count
132
Registration Number
NCT02073123
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

🇺🇸

Penn State Hershey Cancer Institue, Hershey, Pennsylvania, United States

🇺🇸

Augusta University, Augusta, Georgia, United States

and more 3 locations

Immunotherapy Study for Patients With Stage IV Melanoma

Phase 2
Terminated
Conditions
Stage IV Melanoma
Metastatic Melanoma
Interventions
Drug: HyperAcute®-Melanoma (HAM) Immunotherapy
First Posted Date
2014-02-04
Last Posted Date
2023-04-18
Lead Sponsor
NewLink Genetics Corporation
Target Recruit Count
47
Registration Number
NCT02054520
Locations
🇺🇸

University of Tennessee Medical Center, Knoxville, Tennessee, United States

🇺🇸

University of Kansas Cancer Center, Westwood, Kansas, United States

🇺🇸

Oncology Specialists, Niles, Illinois, United States

and more 2 locations
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