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
-

A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

First Posted Date
2017-01-06
Last Posted Date
2024-03-22
Lead Sponsor
ALX Oncology Inc.
Target Recruit Count
174
Registration Number
NCT03013218
Locations
πŸ‡ΊπŸ‡Έ

Seattle Cancer Care Alliance, Seattle, Washington, United States

πŸ‡°πŸ‡·

Seoul National University Hospital, Seoul, Korea, Republic of

πŸ‡°πŸ‡·

Samsung Medical Center, Seoul, Korea, Republic of

and more 7 locations

Pembrolizumab +/- SD-101 in Hormone-NaΓ―ve Oligometastatic Prostate Cancer With RT and iADT

First Posted Date
2017-01-02
Last Posted Date
2024-12-06
Lead Sponsor
David Oh
Target Recruit Count
23
Registration Number
NCT03007732
Locations
πŸ‡ΊπŸ‡Έ

University of California San Francisco, San Francisco, California, United States

Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

First Posted Date
2016-12-30
Last Posted Date
2024-10-08
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
41
Registration Number
NCT03006302
Locations
πŸ‡ΊπŸ‡Έ

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Participants With Selected Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-12-30
Last Posted Date
2021-05-20
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
6
Registration Number
NCT03006887
Locations
πŸ‡―πŸ‡΅

Eisai Trial Site 1, Chuo-ku, Tokyo, Japan

A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade

First Posted Date
2016-12-28
Last Posted Date
2021-11-08
Lead Sponsor
Targovax Oy
Target Recruit Count
21
Registration Number
NCT03003676
Locations
πŸ‡³πŸ‡΄

Oslo University Hospital - The Norwegian Radium Hospital, Oslo, Norway

πŸ‡ΊπŸ‡Έ

University of Maryland Comprehensive Cancer Center, Baltimore, Maryland, United States

πŸ‡ΊπŸ‡Έ

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 1 locations

SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC

First Posted Date
2016-12-28
Last Posted Date
2024-10-15
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
57
Registration Number
NCT03004183
Locations
πŸ‡ΊπŸ‡Έ

Houston Methodist Cancer Center, Houston, Texas, United States

A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2016-12-21
Last Posted Date
2024-11-06
Lead Sponsor
Adrienne G. Waks
Target Recruit Count
50
Registration Number
NCT02999477
Locations
πŸ‡ΊπŸ‡Έ

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

Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2016-12-20
Last Posted Date
2024-05-02
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
42
Registration Number
NCT02998268
Locations
πŸ‡ΊπŸ‡Έ

University of Michigan, Ann Arbor, Michigan, United States

πŸ‡ΊπŸ‡Έ

USC Keck School of Medicine, Norris Cancer Center, Los Angeles, California, United States

πŸ‡ΊπŸ‡Έ

Weill Cornell Medicine, New York, New York, United States

and more 1 locations

Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

First Posted Date
2016-12-20
Last Posted Date
2024-03-20
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
34
Registration Number
NCT02998567
Locations
πŸ‡¬πŸ‡§

Royal Marsden Hospital, Sutton, Surrey, United Kingdom

πŸ‡¬πŸ‡§

UCLH, London, United Kingdom

Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia

First Posted Date
2016-12-19
Last Posted Date
2022-12-28
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
10
Registration Number
NCT02996474
Locations
πŸ‡ΊπŸ‡Έ

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

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