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 Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Phase 3

Recruiting

Conditions: Cancer

Interventions: Drug: Atezolizumab
Drug: Cobimetinib
Drug: Bevacizumab
Drug: Vemurafenib
Drug: Alectinib
Drug: Pembrolizumab
Drug: FAP IL2V
Drug: Sunitinib
Drug: Venetoclax
Drug: Enzalutamide
Drug: Paclitaxel
Drug: Niraparib
Drug: Cabozantinib
Drug: Pemetrexed
Drug: Emactuzumab
Drug: Rucaparib

First Posted Date: 2018-12-07

Last Posted Date: 2024-12-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1000

Registration Number: NCT03768063

Locations: 🇺🇸
Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr, Birmingham, Alabama, United States
🇺🇸
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network, Scottsdale, Arizona, United States
🇺🇸
University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock, Arkansas, United States

and more 199 locations

An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma

Phase 2

Completed

Conditions: Melanoma

Interventions: Drug: Entinostat
Drug: Pembrolizumab

First Posted Date: 2018-12-05

Last Posted Date: 2024-01-10

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 11

Registration Number: NCT03765229

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

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

Phase 1

Completed

Conditions: Acute Myelogenous Leukemia
Ovarian Cancer
Colorectal Cancer
Triple-negative Breast Cancer
Small-cell Lung Cancer

Interventions: Biological: galinpepimut-S
Biological: pembrolizumab
Other: Montanide
Biological: GM-CSF

First Posted Date: 2018-12-03

Last Posted Date: 2024-11-19

Lead Sponsor: Sellas Life Sciences Group

Target Recruit Count: 26

Registration Number: NCT03761914

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
🇺🇸
Innovative Clinical Research Institute (ICRI), Whittier, California, United States

and more 3 locations

Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)

Phase 1

Recruiting

Conditions: Mesotheliomas Pleural

Interventions: Drug: Pembrolizumab
Procedure: Indocyanine Green (ICG) Image-Guided Surgery
Drug: Cisplatin
Drug: Pemetrexed

First Posted Date: 2018-11-30

Last Posted Date: 2024-07-16

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 20

Registration Number: NCT03760575

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

Neoadjuvant PD-1 Blockade in Patients With Stage IIB/C Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Pembrolizumab
Procedure: Wide Excision and Sentinel Lymph Node (SLN) Biopsy

First Posted Date: 2018-11-29

Last Posted Date: 2024-07-31

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 63

Registration Number: NCT03757689

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
University of Louisville, Louisville, Kentucky, United States
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)

Phase 2

Completed

Conditions: Hepatocellular Carcinoma (HCC)

Interventions: Drug: Pembrolizumab
Procedure: Radio Frequency Ablation (RFA)
Procedure: Microwave Ablation (MWA)
Radiation: Brachytherapy
Drug: Transarterial Chemoembolisation (TACE)

First Posted Date: 2018-11-27

Last Posted Date: 2024-07-22

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Target Recruit Count: 30

Registration Number: NCT03753659

Locations: 🇩🇪
Hannover Medical School, Hannover, Niedersachsen, Germany

Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

Phase 2

Conditions: Prostate Cancer

Interventions: Drug: Pembrolizumab
Drug: Enzalutamide

First Posted Date: 2018-11-26

Last Posted Date: 2022-04-20

Lead Sponsor: Mark Garzotto, MD

Target Recruit Count: 32

Registration Number: NCT03753243

Locations: 🇺🇸
VA Portland Healthcare System, Portland, Oregon, United States

Trial of Pembrolizumab in Cancer of Unknown Primary

Phase 2

Active, not recruiting

Conditions: Cancer of Unknown Primary Site

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-11-26

Last Posted Date: 2023-12-06

Lead Sponsor: Imperial College London

Target Recruit Count: 77

Registration Number: NCT03752333

Locations: 🇬🇧
Hammersmith Hospital, London, United Kingdom

Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

Phase 1

Terminated

Conditions: Other Skin

Interventions: Biological: Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR
Drug: Avelumab
Biological: Pembrolizumab
Biological: Interferon Gamma-1b

First Posted Date: 2018-11-20

Last Posted Date: 2024-10-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 7

Registration Number: NCT03747484

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

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab

Phase 2

Active, not recruiting

Conditions: Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Paclitaxel
Drug: Trastuzumab
Drug: Pertuzumab
Drug: Pembrolizumab

First Posted Date: 2018-11-20

Last Posted Date: 2024-12-27

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 138

Registration Number: NCT03747120

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
New Mexico Cancer Center, Albuquerque, New Mexico, United States

and more 2 locations

Drug Development Updates

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