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)

Clinical Trials

Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery

Phase 1

Completed

Conditions: Head and Neck Squamous Cell Carcinoma
Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Recurrent Nasopharynx Carcinoma
Recurrent Salivary Gland Carcinoma
Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
Stage III Major Salivary Gland Carcinoma
Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage III Nasopharyngeal Carcinoma
Stage IV Nasopharyngeal Carcinoma
Stage IVA Major Salivary Gland Carcinoma

Interventions: Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Drug: Vorinostat

First Posted Date: 2015-09-02

Last Posted Date: 2024-11-26

Lead Sponsor: University of Washington

Target Recruit Count: 50

Registration Number: NCT02538510

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma

Phase 1

Terminated

Conditions: Lymphoma, T-Cell, Peripheral

Interventions: Drug: MK-3475
Drug: Copanlisib

First Posted Date: 2015-08-28

Last Posted Date: 2022-07-08

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 17

Registration Number: NCT02535247

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

GSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: GSK3174998
Drug: Pembrolizumab

First Posted Date: 2015-08-19

Last Posted Date: 2021-05-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 141

Registration Number: NCT02528357

Locations: 🇳🇱
GSK Investigational Site, Amsterdam, Netherlands

A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours

Phase 1

Active, not recruiting

Conditions: Solid Tumors

Interventions: Drug: ETC-1922159
Drug: Pembrolizumab

First Posted Date: 2015-08-13

Last Posted Date: 2024-10-08

Lead Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities

Target Recruit Count: 89

Registration Number: NCT02521844

Locations: 🇺🇸
University of Arizona Cancer Center, 3838 N. Campbell Avenue, RM 2111, Site 203, Tucson, Arizona, United States
🇸🇬
National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Site 101, Singapore, Singapore
🇸🇬
National Cancer Centre Singapore, 11 Hospital Drive, Site 102, Singapore, Singapore

and more 8 locations

Pembrolizumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 2

Active, not recruiting

Conditions: Stage III Fallopian Tube Cancer AJCC v7
Stage III Ovarian Cancer AJCC v6 and v7
Stage IIIA Primary Peritoneal Cancer AJCC v7
Stage IIIB Primary Peritoneal Cancer AJCC v7
Stage IV Primary Peritoneal Cancer AJCC v7
Stage III Primary Peritoneal Cancer AJCC v7
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Stage IIIC Primary Peritoneal Cancer AJCC v7

Interventions: Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Biological: Pembrolizumab
Other: Pharmacological Study

First Posted Date: 2015-08-11

Last Posted Date: 2025-05-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 31

Registration Number: NCT02520154

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson in The Woodlands, The Woodlands, Texas, United States
🇺🇸
MD Anderson in Sugar Land, Sugar Land, Texas, United States

and more 2 locations

Safety Study of a Helper Peptide Vaccine Plus Pembrolizumab

Phase 1

Completed

Conditions: Melanoma

Interventions: Biological: 6MHP
Drug: Pembrolizumab

First Posted Date: 2015-08-04

Last Posted Date: 2023-08-25

Lead Sponsor: Craig L Slingluff, Jr

Target Recruit Count: 22

Registration Number: NCT02515227

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

Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)

Phase 1

Completed

Conditions: Breast Neoplasm

Interventions: Drug: Eribulin Mesylate
Drug: Pembrolizumab

First Posted Date: 2015-07-31

Last Posted Date: 2022-05-05

Lead Sponsor: Eisai Inc.

Target Recruit Count: 258

Registration Number: NCT02513472

Locations: 🇺🇸
Facility #2, San Antonio, Texas, United States
🇺🇸
Facility #1, Madison, Wisconsin, United States

A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Oral CC-486
Drug: Romidepsin
Drug: MK-3475

First Posted Date: 2015-07-30

Last Posted Date: 2022-03-22

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 27

Registration Number: NCT02512172

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

Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

Phase 1

Terminated

Conditions: ALK-positive Advanced NSCLC

Interventions: Drug: Crizotinib
Drug: Pembrolizumab

First Posted Date: 2015-07-29

Last Posted Date: 2019-07-01

Lead Sponsor: Pfizer

Target Recruit Count: 9

Registration Number: NCT02511184

Locations: 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 11 locations

Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611

Phase 1

Completed

Conditions: Hepatocellular Carcinoma
Liver Tumors
Cutaneous or Subcutaneous Lymph Node
Liver Metastases

Interventions: Drug: Talimogene Laherparepvec
Drug: Pembrolizumab

First Posted Date: 2015-07-28

Last Posted Date: 2024-08-06

Lead Sponsor: Amgen

Target Recruit Count: 127

Registration Number: NCT02509507

Locations: 🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸
University of California Los Angeles, Santa Monica, California, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 29 locations

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