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

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

Phase 3

Completed

Conditions: UC (Urothelial Cancer)

Interventions: Drug: Pembrolizumab
Drug: Epacadostat
Drug: Placebo

First Posted Date: 2017-12-05

Last Posted Date: 2021-12-16

Lead Sponsor: Incyte Corporation

Target Recruit Count: 93

Registration Number: NCT03361865

Locations: 🇺🇸
University of California Irvine Medical Center, Orange, California, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
University of Tennessee Medical Center Knoxville, Knoxville, Tennessee, United States

and more 140 locations

Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma

Phase 1

Active, not recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Rituximab
Biological: Neo Vax
Drug: Pembrolizumab

First Posted Date: 2017-12-05

Last Posted Date: 2024-03-19

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 20

Registration Number: NCT03361852

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

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumors

Interventions: Drug: INCB001158
Drug: Epacadostat
Drug: Pembrolizumab

First Posted Date: 2017-12-04

Last Posted Date: 2020-05-21

Lead Sponsor: Incyte Corporation

Target Recruit Count: 5

Registration Number: NCT03361228

Locations: 🇺🇸
University of Alabama, Birmingham, Alabama, United States
🇺🇸
The University of Chicago Medicine, Chicago, Illinois, United States

Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors

Phase 2

Suspended

Conditions: Thyroid Cancer
Salivary Gland Cancer

Interventions: Drug: Pembrolizumab
Drug: Docetaxel

First Posted Date: 2017-12-04

Last Posted Date: 2024-07-31

Lead Sponsor: University of Chicago

Target Recruit Count: 46

Registration Number: NCT03360890

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

Phase 3

Active, not recruiting

Conditions: Head and Neck Cancer

Interventions: Drug: Pembrolizumab
Drug: Cetuximab
Drug: Epacadostat
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-Fluorouracil

First Posted Date: 2017-11-30

Last Posted Date: 2024-06-28

Lead Sponsor: Incyte Corporation

Target Recruit Count: 89

Registration Number: NCT03358472

Locations: 🇺🇸
U of Kansas Cancer Center, Westwood, Kansas, United States
🇦🇺
Royal Brisbane & Women s Hospital, Herston, Queensland, Australia
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

and more 70 locations

Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC

Phase 1

Completed

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: Regorafenib(Stivarga, BAY73-4506)
Drug: Pembrolizumab

First Posted Date: 2017-11-20

Last Posted Date: 2023-07-25

Lead Sponsor: Bayer

Target Recruit Count: 58

Registration Number: NCT03347292

Locations: 🇺🇸
USC Norris Hospital and Clinics, Los Angeles, California, United States
🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇩🇪
Universitätsklinikum Köln, Köln, Nordrhein-Westfalen, Germany

and more 4 locations

Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Phase 1

Completed

Conditions: Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Interventions: Drug: Blinatumomab
Drug: Pembrolizumab

First Posted Date: 2017-11-14

Last Posted Date: 2024-10-17

Lead Sponsor: Amgen

Target Recruit Count: 31

Registration Number: NCT03340766

Locations: 🇪🇸
Research Site, Madrid, Spain

Pembrolizumab as Neoadjuvant Treatment in HCC

Phase 2

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-11-09

Last Posted Date: 2017-11-09

Lead Sponsor: Kindai University

Target Recruit Count: 50

Registration Number: NCT03337841

A Phase II Study to Determine Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Hodgkin Lymphoma

Interventions: Drug: pembrolizumab

First Posted Date: 2017-11-06

Last Posted Date: 2023-08-21

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 27

Registration Number: NCT03331731

Locations: 🇦🇺
Concord Hospital, Concord, New South Wales, Australia
🇦🇺
Linear Clinical Research, Nedlands, Perth, Australia
🇦🇺
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

and more 3 locations

A SU2C Catalyst® Trial of a PD1 Inhibitor With or Without a Vitamin D Analog for the Maintenance of Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Cancer
Pancreas Adenocarcinoma
Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Pembrolizumab
Drug: paricalcitol
Drug: placebo

First Posted Date: 2017-11-06

Last Posted Date: 2022-12-27

Lead Sponsor: Translational Genomics Research Institute

Target Recruit Count: 24

Registration Number: NCT03331562

Locations: 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸
The University of Kansas Cancer Center, Westwood, Kansas, United States

and more 3 locations

Drug Development Updates

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