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

Microbiome Immunotherapy Toxicity and Response Evaluation

Recruiting

Conditions: Melanoma
Renal Cancer
Lung Cancer

Interventions: Drug: Nivolumab
Drug: Durvalumab
Drug: Pembrolizumab
Drug: Ipilimumab
Drug: Tremelimumab
Drug: Atezolizumab
Drug: Bevacizumab

First Posted Date: 2019-09-27

Last Posted Date: 2023-02-16

Lead Sponsor: CCTU- Cancer Theme

Target Recruit Count: 1800

Registration Number: NCT04107168

Locations: 🇬🇧
University Hospitals Dorest NHS Foundation Trust, Bournemouth, United Kingdom
🇬🇧
Royal United Hospitals Bath NHS Foundation Trust, Bath, United Kingdom
🇬🇧
Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

and more 10 locations

A Study of MTL-CEBPA in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours (TIMEPOINT)

Phase 1

Active, not recruiting

Conditions: Solid Tumor, Adult

Interventions: Drug: MTL-CEBPA
Drug: Pembrolizumab

First Posted Date: 2019-09-26

Last Posted Date: 2023-06-05

Lead Sponsor: Mina Alpha Limited

Target Recruit Count: 108

Registration Number: NCT04105335

Locations: 🇬🇧
Guys and St Thomas NHS Foundation Trust, London, United Kingdom
🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom
🇬🇧
Freeman Hospital, Newcastle Upn Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom

A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

Phase 2

Recruiting

Conditions: Metastatic Castration Resistant Prostate Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-09-26

Last Posted Date: 2024-03-20

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 30

Registration Number: NCT04104893

Locations: 🇺🇸
Washington DC VA Medical Center, Washington, DC, Washington, District of Columbia, United States
🇺🇸
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States
🇺🇸
Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, Florida, United States

and more 9 locations

A Study of LY3435151 in Participants With Solid Tumors

Phase 1

Terminated

Conditions: Hepatocellular Carcinoma
Gastric Adenocarcinoma
Cervical Carcinoma
Solid Tumor
Triple-negative Breast Cancer
Head and Neck Squamous Cell Carcinoma
Undifferentiated Pleomorphic Sarcoma
Leiomyosarcoma
High Grade Serous Ovarian Carcinoma

Interventions: Drug: LY3435151
Drug: Pembrolizumab

First Posted Date: 2019-09-23

Last Posted Date: 2021-08-31

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 2

Registration Number: NCT04099277

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇯🇵
National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan

Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer

Phase 2

Suspended

Conditions: Triple Negative Breast Cancer
Anthracycline-refractory TNBC

Interventions: Drug: Docetaxel
Drug: Pembrolizumab
Drug: IL-12 gene therapy

First Posted Date: 2019-09-19

Last Posted Date: 2024-02-21

Lead Sponsor: The Methodist Hospital Research Institute

Target Recruit Count: 30

Registration Number: NCT04095689

Locations: 🇺🇸
Houston Methodist Cancer Center, Houston, Texas, United States

Study of CTDNA Response Adaptive Immuno-Chemotherapy in NSCLC

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-09-17

Last Posted Date: 2024-01-24

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 230

Registration Number: NCT04093167

Locations: 🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada
🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇨🇦
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

and more 3 locations

Treatment of PD-1 Inhibitor in AIDS-associated PML

Phase 2

Conditions: Progressive Multifocal Leukoencephalopathy
AIDS

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-09-17

Last Posted Date: 2019-09-20

Lead Sponsor: First Affiliated Hospital of Zhejiang University

Target Recruit Count: 10

Registration Number: NCT04091932

Locations: 🇨🇳
the first affiliated hospital of Zhejiang university school of medicine, Hangzhou, Zhejiang, China

pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Cancer

Interventions: Biological: pTVG-HP
Biological: pTVG-AR
Drug: Pembrolizumab

First Posted Date: 2019-09-16

Last Posted Date: 2024-07-24

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 60

Registration Number: NCT04090528

Locations: 🇺🇸
Washington University Siteman Cancer Center, Saint Louis, Missouri, United States
🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors

Phase 1

Recruiting

Conditions: Malignant Solid Tumor
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Melanoma
Head and Neck Squamous Cell Carcinoma (HNSCC)
Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions: Biological: GEN1042
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-FU
Drug: Gemcitabine
Drug: Nab paclitaxel
Drug: Pemetrexed
Drug: Paclitaxel

First Posted Date: 2019-09-10

Last Posted Date: 2025-01-07

Lead Sponsor: Genmab

Target Recruit Count: 1287

Registration Number: NCT04083599

Locations: 🇺🇸
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
🇺🇸
Cancer & Blood Specialty Clinic, Los Alamitos, California, United States
🇺🇸
Moores Cancer Center at the UC San Diego Health, San Diego, California, United States

and more 72 locations

Pembrolizumab Before Surgery for the Treatment of Mismatch Repair Deficient Locally Advanced Solid Cancers

Phase 2

Completed

Conditions: Locally Advanced Malignant Solid Neoplasm

Interventions: Biological: Pembrolizumab

First Posted Date: 2019-09-09

Last Posted Date: 2024-11-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 35

Registration Number: NCT04082572

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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