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

Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat

Phase 2

Terminated

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Unresectable Head and Neck Squamous Cell Carcinoma

Interventions: Device: ImmunoPulse
Drug: Epacadostat
Drug: Pembrolizumab
Biological: CORVax
Drug: Tavokinogene telseplasmid

First Posted Date: 2019-01-30

Last Posted Date: 2023-05-09

Lead Sponsor: Chase Heaton, MD

Target Recruit Count: 14

Registration Number: NCT03823131

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)

Phase 3

Completed

Conditions: Malignant Melanoma

Interventions: Biological: Pembrolizumab
Drug: Placebo for lenvatinib
Drug: Lenvatinib

First Posted Date: 2019-01-29

Last Posted Date: 2024-12-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 674

Registration Number: NCT03820986

Locations: 🇦🇺
Princess Alexandra Hospital ( Site 0454), Wooloongabba, Queensland, Australia
🇺🇸
University of North Carolina - Cancer Hospital ( Site 0751), Chapel Hill, North Carolina, United States
🇨🇳
Yunnan Cancer Hospital ( Site 0604), Kunming, Yunnan, China

and more 116 locations

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.

Phase 2

Active, not recruiting

Conditions: Advanced Melanoma

Interventions: Biological: Autogene cevumeran
Drug: Pembrolizumab

First Posted Date: 2019-01-24

Last Posted Date: 2024-10-24

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 131

Registration Number: NCT03815058

Locations: 🇺🇸
HonorHealth Research Institute ? Bisgrove, Scottsdale, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
University of California San Diego Moores Cancer Center, La Jolla, California, United States

and more 54 locations

Bevacizumab and Pembrolizumab Combination in Platinum-resistant Recurrent/Metastatic NPC

Phase 1

Active, not recruiting

Conditions: Locally Recurrent Cancer
Metastatic Nasopharyngeal Cancer

Interventions: Drug: pembrolizumab
Drug: bevacizumab

First Posted Date: 2019-01-23

Last Posted Date: 2024-11-22

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 48

Registration Number: NCT03813394

Locations: 🇸🇬
National University Hospital, Singapore, Singapore

Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC

Phase 2

Active, not recruiting

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-01-23

Last Posted Date: 2024-11-12

Lead Sponsor: University College, London

Target Recruit Count: 63

Registration Number: NCT03813836

Locations: 🇬🇧
Aberdeen Royal Infirmary (NHS Grampian), Aberdeen, United Kingdom
🇬🇧
Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust), Bristol, United Kingdom
🇬🇧
Western General Hospital (NHS Lothian), Edinburgh, United Kingdom

and more 9 locations

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer

Phase 1

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma
Non-small Cell Lung Cancer
Melanoma
Gastric Adenocarcinoma
Metastatic Solid Tumors
Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Esophageal Adenocarcinoma
Oropharyngeal Carcinoma

Interventions: Drug: INBRX-105 - PDL1x41BB antibody
Drug: Pembrolizumab

First Posted Date: 2019-01-18

Last Posted Date: 2024-10-23

Lead Sponsor: Inhibrx Biosciences, Inc

Target Recruit Count: 160

Registration Number: NCT03809624

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Washington University, Saint Louis, Missouri, United States
🇺🇸
START Mountain Region, West Valley City, Utah, United States

and more 20 locations

A Study of ASP1951 in Subjects With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Advanced Solid Tumors

Interventions: Drug: ASP1951
Drug: pembrolizumab

First Posted Date: 2019-01-10

Last Posted Date: 2024-11-01

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 119

Registration Number: NCT03799003

Locations: 🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 29 locations

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Phase 2

Completed

Conditions: Advanced Solid Tumors
Triple Negative Breast Cancer
Ovarian Cancer
Gastric Cancer
Colorectal Cancer
Glioblastoma
Biliary Tract Cancers
Pancreatic Cancer

Interventions: Drug: Lenvatinib
Biological: Pembrolizumab

First Posted Date: 2019-01-09

Last Posted Date: 2024-11-15

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 603

Registration Number: NCT03797326

Locations: 🇺🇸
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049), Dallas, Texas, United States
🇦🇺
Sir Charles Gairdner Hospital ( Site 0903), Nedlands, Western Australia, Australia
🇺🇸
City of Hope ( Site 0002), Duarte, California, United States

and more 85 locations

Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

Phase 3

Active, not recruiting

Conditions: Lung Non-Squamous Non-Small Cell Carcinoma
Stage IIIC Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Drug: Pemetrexed
Procedure: Positron Emission Tomography

First Posted Date: 2019-01-04

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 600

Registration Number: NCT03793179

Locations: 🇺🇸
Swedish Covenant Hospital, Chicago, Illinois, United States
🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Advocate Illinois Masonic Medical Center, Chicago, Illinois, United States

and more 1095 locations

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC

Phase 1

Completed

Conditions: Metastatic Castration-resistant Prostate Cancer
Prostate Cancer

Interventions: Drug: acapatamab
Drug: Cytochrome P450 (CYP) Cocktail
Drug: Pembrolizumab
Drug: Etanercept

First Posted Date: 2019-01-03

Last Posted Date: 2024-12-06

Lead Sponsor: Amgen

Target Recruit Count: 212

Registration Number: NCT03792841

Locations: 🇺🇸
City of Hope at Long Beach Elm, Long Beach, California, United States
🇺🇸
El Camino Hospital, Campbell, California, United States
🇺🇸
Indiana University, Indianapolis, Indiana, United States

and more 27 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy