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

Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer

Phase 1

Withdrawn

Conditions: Carcinoma, Renal Cell
Melanoma

Interventions: Drug: Pembrolizumab
Drug: Interleukin-2

First Posted Date: 2017-04-13

Last Posted Date: 2019-07-12

Lead Sponsor: William Grosh, MD

Registration Number: NCT03111901

Locations: 🇺🇸
University of Virginia Cancer Center, Charlottesville, Virginia, United States

P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
Recurrent Platinum-Resistant Ovarian Carcinoma
Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Interventions: Biological: Modified Vaccinia Virus Ankara Vaccine Expressing p53
Biological: Pembrolizumab

First Posted Date: 2017-04-13

Last Posted Date: 2024-10-08

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 29

Registration Number: NCT03113487

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Pembrolizumab Plus Y90 Radioembolization in HCC Subjects

Early Phase 1

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab
Device: Y90 radioembolization

First Posted Date: 2017-04-04

Last Posted Date: 2023-02-06

Lead Sponsor: Ashwin Somasundaram

Target Recruit Count: 30

Registration Number: NCT03099564

Locations: 🇺🇸
University of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Radium-223
Drug: Pembrolizumab

First Posted Date: 2017-03-28

Last Posted Date: 2024-11-21

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 45

Registration Number: NCT03093428

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Dendritic Cell Vaccination in Patients With Advanced Melanoma

Phase 1

Completed

Conditions: Melanoma

Interventions: Biological: Mature dendritic cell (DC) vaccine
Drug: Cyclophosphamide 300mg/m^2
Drug: Pembrolizumab

First Posted Date: 2017-03-28

Last Posted Date: 2024-12-24

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 5

Registration Number: NCT03092453

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Pembrolizumab in Patients With Leptomeningeal Disease

Phase 2

Terminated

Conditions: Patients With Leptomeningeal Disease

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-03-27

Last Posted Date: 2021-01-26

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 13

Registration Number: NCT03091478

Locations: 🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity

Phase 2

Active, not recruiting

Conditions: Soft Tissue Sarcoma of the Extremity

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-03-27

Last Posted Date: 2023-11-18

Lead Sponsor: Sarcoma Alliance for Research through Collaboration

Target Recruit Count: 126

Registration Number: NCT03092323

Locations: 🇺🇸
The Ohio State University, Columbus, Ohio, United States
🇺🇸
Mayo Clinic- Florida, Jacksonville, Florida, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 17 locations

Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker

Phase 2

Completed

Conditions: Melanoma

Interventions: Diagnostic Test: FDG PET/CT scan
Diagnostic Test: C11-AMT PET scan
Drug: Pembrolizumab
Diagnostic Test: CT scan

First Posted Date: 2017-03-24

Last Posted Date: 2023-11-15

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 27

Registration Number: NCT03089606

Locations: 🇺🇸
UNC Rex Healthcare, Raleigh, North Carolina, United States
🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

Phase 2

Completed

Conditions: Adenoid Cystic Carcinoma

Interventions: Radiation: Radiation
Drug: Pembrolizumab

First Posted Date: 2017-03-22

Last Posted Date: 2022-10-14

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 21

Registration Number: NCT03087019

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Trial of Consolidation Pembrolizumab After Concurrent Chemotherapy and Proton Reirradiation for Thoracic Recurrences of Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-03-22

Last Posted Date: 2024-01-18

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 32

Registration Number: NCT03087760

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Drug Development Updates

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