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

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

Phase 1

Completed

Conditions: Cervical Cancer
Advanced Solid Tumors
EGFR Positive Solid Tumor
Hepatocellular Carcinoma
Renal Cell Carcinoma
NSCLC
Urothelial Carcinoma
Colorectal Cancer
Small Cell Lung Cancer
Melanoma

Interventions: Drug: FT500
Drug: Cyclophosphamide
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Atezolizumab
Drug: Fludarabine
Drug: IL-2

First Posted Date: 2019-02-15

Last Posted Date: 2023-05-01

Lead Sponsor: Fate Therapeutics

Target Recruit Count: 37

Registration Number: NCT03841110

Locations: 🇺🇸
Hackensack University Medical Center/John Theurer Cancer Center, Hackensack, New Jersey, United States
🇺🇸
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 1 locations

A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)

Phase 2

Active, not recruiting

Conditions: Endometrial Cancer

Interventions: Drug: Pembrolizumab
Drug: IMGN853

First Posted Date: 2019-02-11

Last Posted Date: 2024-11-08

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 18

Registration Number: NCT03835819

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Northwell Cancer Institute, Lake Success, New York, United States
🇺🇸
University of Massachusetts, Worcester, Massachusetts, United States

Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma
Bladder Cancer
Microsatellite Instability-High
Ovarian Cancer
Non-small Cell Lung Cancer

Interventions: Other: DPX-Survivac
Drug: Pembrolizumab
Drug: Cyclophosphamide

First Posted Date: 2019-02-11

Last Posted Date: 2022-03-31

Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Target Recruit Count: 184

Registration Number: NCT03836352

Locations: 🇺🇸
Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton, Florida, United States
🇨🇦
William Osler Health System, Brampton, Ontario, Canada
🇨🇦
Sunnybrook Research Institute, Toronto, Ontario, Canada

and more 20 locations

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

Phase 3

Completed

Conditions: Prostatic Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Docetaxel
Drug: Placebo
Drug: Prednisone
Drug: Dexamethasone

First Posted Date: 2019-02-08

Last Posted Date: 2024-07-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1030

Registration Number: NCT03834506

Locations: 🇨🇦
Lakeridge Health ( Site 0117), Oshawa, Ontario, Canada
🇨🇦
Sunnybrook Research Institute ( Site 0108), Toronto, Ontario, Canada
🇺🇸
Mount Sinai Hospital Medical Center ( Site 0042), Chicago, Illinois, United States

and more 212 locations

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

Phase 3

Completed

Conditions: Prostatic Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Abiraterone acetate
Drug: Olaparib
Drug: Prednisone
Drug: Enzalutamide
Drug: Prednisolone

First Posted Date: 2019-02-08

Last Posted Date: 2025-01-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 793

Registration Number: NCT03834519

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0081), Los Angeles, California, United States
🇨🇦
Princess Margaret Cancer Centre ( Site 0107), Toronto, Ontario, Canada
🇺🇸
Beth Israel Deaconess Medical Ctr. ( Site 0093), Boston, Massachusetts, United States

and more 190 locations

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

Phase 3

Active, not recruiting

Conditions: Prostatic Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Placebo
Drug: Enzalutamide

First Posted Date: 2019-02-08

Last Posted Date: 2024-12-20

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1244

Registration Number: NCT03834493

Locations: 🇺🇸
St. Joseph Heritage Healthcare ( Site 0069), Fullerton, California, United States
🇺🇸
Georgia Cancer Center at Augusta University ( Site 0026), Augusta, Georgia, United States
🇺🇸
Gabrail Cancer Center-Research ( Site 0096), Canton, Ohio, United States

and more 255 locations

Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)

Phase 1

Terminated

Conditions: Advanced/Metastatic Solid Tumors

Interventions: Drug: Selumetinib
Drug: Pembrolizumab

First Posted Date: 2019-02-07

Last Posted Date: 2024-11-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 32

Registration Number: NCT03833427

Locations: 🇨🇦
Princess Margaret Cancer Centre ( Site 0014), Toronto, Ontario, Canada
🇺🇸
City of Hope National Medical Center ( Site 0004), Duarte, California, United States
🇺🇸
START Midwest ( Site 0001), Grand Rapids, Michigan, United States

and more 3 locations

Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors

Early Phase 1

Active, not recruiting

Conditions: Solid Tumors
Identified by NGS, PCR or IHC

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-02-06

Last Posted Date: 2024-04-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 17

Registration Number: NCT03832569

Locations: 🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States

and more 4 locations

Pembrolizumab-Epacadostat Combination to Treat Muscle-invasive Bladder UrotheLIAl canceR: PECULIAR Study

Phase 2

Withdrawn

Conditions: Muscle-invasive Bladder Cancer

Interventions: Drug: Pembrolizumab
Drug: Epacadostat

First Posted Date: 2019-02-06

Last Posted Date: 2021-02-26

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Registration Number: NCT03832673

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma

Phase 1

Recruiting

Conditions: Advanced Cancer
Solid Tumor
Lymphoma

Interventions: Drug: NUC-7738
Drug: Pembrolizumab

First Posted Date: 2019-02-04

Last Posted Date: 2024-11-11

Lead Sponsor: NuCana plc

Target Recruit Count: 135

Registration Number: NCT03829254

Locations: 🇬🇧
Freeman Hospital, Newcastle, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom
🇬🇧
The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

and more 2 locations

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