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
-

Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM)

First Posted Date
2016-09-20
Last Posted Date
2023-08-22
Lead Sponsor
Hackensack Meridian Health
Target Recruit Count
12
Registration Number
NCT02906332
Locations
🇺🇸

John Theurer Cancer Center-Hackensack Meridian Health, Hackensack, New Jersey, United States

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

First Posted Date
2016-09-16
Last Posted Date
2023-02-24
Lead Sponsor
Incyte Corporation
Target Recruit Count
260
Registration Number
NCT02903914
Locations
🇺🇸

Johns Hopkins, Baltimore, Maryland, United States

🇺🇸

BIDMC, Boston, Massachusetts, United States

🇺🇸

MD Anderson, Houston, Texas, United States

and more 16 locations

JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors

First Posted Date
2016-09-16
Last Posted Date
2023-07-03
Lead Sponsor
Jounce Therapeutics, Inc.
Target Recruit Count
242
Registration Number
NCT02904226
Locations
🇺🇸

The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

and more 13 locations

Pembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer

First Posted Date
2016-09-15
Last Posted Date
2021-04-06
Lead Sponsor
Yonsei University
Target Recruit Count
41
Registration Number
NCT02901301
Locations
🇰🇷

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

First Posted Date
2016-09-15
Last Posted Date
2021-02-16
Lead Sponsor
Prof. Dr. med. Dirk Schadendorf
Target Recruit Count
16
Registration Number
NCT02902042
Locations
🇩🇪

University Hospital Essen, Department of Dermatology, Skin Cancer Center, Essen, North Rhine-Westphalia, Germany

🇩🇪

HELIOS Klinikum Krefeld, Krefeld, North Rhine-Westphalia, Germany

🇩🇪

Universitätsklinikum Gießen und Marburg GmbH, Klinik für Dermatologie und Allergologie, Gießen, Hessen, Germany

and more 8 locations

Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2016-09-14
Last Posted Date
2024-04-08
Lead Sponsor
Yale University
Target Recruit Count
25
Registration Number
NCT02899793
Locations
🇺🇸

Yale New Haven Hospital, New Haven, Connecticut, United States

Palbociclib and Pembrolizumab in Central Nervous System Metastases

First Posted Date
2016-09-12
Last Posted Date
2024-11-21
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
45
Registration Number
NCT02896335
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Pembrolizumab in HNSCC With Residual Disease After Radiation

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-09-08
Last Posted Date
2023-12-28
Lead Sponsor
Yale University
Target Recruit Count
9
Registration Number
NCT02892201
Locations
🇺🇸

Yale Cancer Center, New Haven, Connecticut, United States

🇺🇸

University of Texas Southwestern Medical Center (UTSW), Dallas, Texas, United States

Pembrolizumab In Central Nervous System Metastases

First Posted Date
2016-09-01
Last Posted Date
2024-03-12
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
101
Registration Number
NCT02886585
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Priscilla Brastianos, Boston, Massachusetts, United States

Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-08-30
Last Posted Date
2021-01-13
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
57
Registration Number
NCT02883556
Locations
🇫🇷

Hôpital Avicenne, Bobigny, France

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