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: -

Clinical Trials

A Trial Assessing the Effect of Pembrolizumab Combined with Radiotherapy in Patients with Relapsed, Refractory, Specified Stages of Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF)/Sezary Syndrome (SS)

Phase 2

Active, not recruiting

Conditions: Cutaneous T Cell Lymphoma
Mycosis Fungoides/Sezary Syndrome

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy

First Posted Date: 2017-12-28

Last Posted Date: 2024-12-09

Lead Sponsor: University College, London

Target Recruit Count: 46

Registration Number: NCT03385226

Locations: 🇬🇧
Guy's & St Thomas', London, United Kingdom
🇬🇧
The Christie, Manchester, United Kingdom
🇬🇧
University Hospital Birmingham, Birmingham, United Kingdom

and more 8 locations

Propranolol Hydrochloride and Pembrolizumab in Treating Patients With Stage IIIC-IV Melanoma That Cannot Be Removed by Surgery

Phase 1

Suspended

Conditions: Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IIIC Cutaneous Melanoma AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Drug: Propranolol Hydrochloride

First Posted Date: 2017-12-27

Last Posted Date: 2024-11-12

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 47

Registration Number: NCT03384836

Locations: 🇺🇸
Emory University Hospital/ Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States

and more 1 locations

Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer

Phase 2

Terminated

Conditions: Non Small Cell Lung Cancer

Interventions: Biological: Pegilodecakin
Drug: Pembrolizumab

First Posted Date: 2017-12-26

Last Posted Date: 2021-01-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 101

Registration Number: NCT03382899

Locations: 🇺🇸
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
🇺🇸
The Oncology Institute of Hope and Innovation, Whittier, California, United States
🇺🇸
Orchard Healthcare Research Inc, Skokie, Illinois, United States

and more 71 locations

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma
Tumor
Oral Cancer
Oropharynx Cancer, Stage III
Cancer
Cancer of Head and Neck
Tumor Metastasis
Cancer, Advanced
Cancer, Metastatic
Tumor Recurrence

Interventions: Drug: Pembrolizumab
Radiation: Radiation therapy
Drug: Cisplatin

First Posted Date: 2017-12-26

Last Posted Date: 2024-08-06

Lead Sponsor: Loren Mell, MD

Target Recruit Count: 114

Registration Number: NCT03383094

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States

and more 4 locations

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

Phase 3

Completed

Conditions: UC (Urothelial Cancer)

Interventions: Drug: Pembrolizumab
Drug: Epacadostat
Drug: Placebo

First Posted Date: 2017-12-15

Last Posted Date: 2021-11-30

Lead Sponsor: Incyte Corporation

Target Recruit Count: 84

Registration Number: NCT03374488

Locations: 🇫🇷
Centre de Lutte Contre le Cancer Francois Baclesse, Caen, France
🇫🇷
Clinique Victor Hugo, Le Mans, France
🇫🇷
Centre Leon Berard, Lyon, France

and more 132 locations

Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651)

Phase 1

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Biological: Pembrolizumab
Drug: Binimetinib
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Irinotecan
Drug: 5-Fluorouracil [5-FU]

First Posted Date: 2017-12-15

Last Posted Date: 2024-11-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 116

Registration Number: NCT03374254

Locations: 🇺🇸
Seattle Cancer Care Alliance ( Site 0104), Seattle, Washington, United States
🇺🇸
Rutgers Cancer Institute of New Jersey ( Site 0107), New Brunswick, New Jersey, United States
🇨🇦
Princess Margaret Cancer Centre ( Site 0122), Toronto, Ontario, Canada

and more 11 locations

A Prospective Study of Constructing Immune Repertoire to Monitor the Therapeutic Effect in NSCLC Patients

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: pembrolizumab

First Posted Date: 2017-12-14

Last Posted Date: 2021-03-18

Lead Sponsor: Sichuan University

Target Recruit Count: 60

Registration Number: NCT03373955

Locations: 🇨🇳
West China Hospital, Sichuan University, Chengdu, Sichuan, China

Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer

Phase 1

Completed

Conditions: Small-cell Lung Cancer

Interventions: Drug: Pegzilarginase
Drug: Pembrolizumab

First Posted Date: 2017-12-13

Last Posted Date: 2021-11-04

Lead Sponsor: Aeglea Biotherapeutics

Target Recruit Count: 68

Registration Number: NCT03371979

Locations: 🇺🇸
University of Alabama, Mitchell Cancer Institute, Mobile, Alabama, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States

and more 19 locations