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

Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-06-23

Last Posted Date: 2023-06-15

Lead Sponsor: AIO-Studien-gGmbH

Target Recruit Count: 30

Registration Number: NCT03197467

Locations: 🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Germany

Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer

Phase 2

Completed

Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Recurrent Esophageal Carcinoma
Recurrent Gastric Carcinoma
Stage IV Esophageal Cancer AJCC v7
Stage IV Gastric Cancer AJCC v7
Unresectable Esophageal Carcinoma

Interventions: Drug: Epacadostat
Drug: Pembrolizumab

First Posted Date: 2017-06-22

Last Posted Date: 2024-01-23

Lead Sponsor: George Albert Fisher

Target Recruit Count: 3

Registration Number: NCT03196232

Locations: 🇺🇸
Stanford University, School of Medicine, Palo Alto, California, United States

Pembrolizumab Cyclophosphamide and Lenalidomide for Patients With Relapsed Multiple Myeloma

Phase 1

Withdrawn

Conditions: Myeloma Multiple

Interventions: Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Pembrolizumab

First Posted Date: 2017-06-19

Last Posted Date: 2017-08-24

Lead Sponsor: University of Leeds

Registration Number: NCT03191981

Locations: 🇬🇧
University College Hospital, London, United Kingdom
🇬🇧
Queen Elizabeth Hospital, Birmingham, United Kingdom
🇬🇧
Southampton General Hospital, Southampton, United Kingdom

and more 1 locations

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

Phase 2

Completed

Conditions: Endometrial Cancer
Cervical Cancer
Uterine Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiation
Drug: Vitamin D
Drug: Aspirin
Drug: Lansoprazole
Drug: Cyclophosphamide
Dietary Supplement: Curcumin

First Posted Date: 2017-06-19

Last Posted Date: 2021-09-08

Lead Sponsor: University Hospital, Ghent

Target Recruit Count: 43

Registration Number: NCT03192059

Locations: 🇧🇪
Institut Jules Bordet, Brussels, Belgium
🇧🇪
University Hospital Antwerp, Antwerp, Belgium
🇧🇪
University Hospital Gent, Gent, Belgium

and more 1 locations

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

Phase 3

Completed

Conditions: Esophageal Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Placebo
Drug: Cisplatin
Drug: 5-FU

First Posted Date: 2017-06-16

Last Posted Date: 2024-10-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 749

Registration Number: NCT03189719

Locations: 🇿🇦
The Medical Oncology Centre of Rosebank ( Site 2506), Johannesburg, Gauteng, South Africa
🇪🇸
Hospital Universitario Central de Asturias ( Site 0708), Oviedo, Asturias, Spain
🇺🇸
University of Maryland Medical Center ( Site 0013), Baltimore, Maryland, United States

and more 186 locations

Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas

Phase 2

Active, not recruiting

Conditions: Lymphoma
Relapsed
Refractory

Interventions: Drug: Entinostat
Drug: Pembrolizumab

First Posted Date: 2017-06-07

Last Posted Date: 2024-08-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 47

Registration Number: NCT03179930

Locations: 🇺🇸
Roswell Park Cancer Institute (Data Collection Only), Buffalo, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 6 locations

Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Hodgkin Lymphoma

Interventions: Drug: Pembrolizumab
Radiation: Involved Site Radiation Therapy

First Posted Date: 2017-06-07

Last Posted Date: 2024-12-05

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 22

Registration Number: NCT03179917

Locations: 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 6 locations

Special Combination of OBP-301 and Pembrolizumab

Phase 1

Completed

Conditions: Advanced Solid Tumor

Interventions: Biological: OBP-301
Drug: Pembrolizumab

First Posted Date: 2017-06-01

Last Posted Date: 2022-09-28

Lead Sponsor: Toshihiko Doi

Target Recruit Count: 22

Registration Number: NCT03172819

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma

Phase 1

Terminated

Conditions: Neoplasms

Interventions: Drug: Letetresgene autoleucel with pembrolizumab
Drug: Letetresgene autoleucel
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Pembrolizumab

First Posted Date: 2017-05-30

Last Posted Date: 2022-01-11

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 6

Registration Number: NCT03168438

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab and Standard of Care Chemotherapy in Squamous Non-Small Cell Lung Cancer and Extensive Stage Small Cell Lung Cancer

Phase 1

Withdrawn

Conditions: Non Small Cell Lung Cancer
NSCLC
Non-small Cell Lung Cancer
Small Cell Lung Extensive Stage

Interventions: Drug: Pembrolizumab
Biological: NEO-PV-01 vaccine
Procedure: Biopsy
Drug: Poly ICLC
Procedure: Leukapheresis
Procedure: Peripheral blood samples

First Posted Date: 2017-05-25

Last Posted Date: 2019-04-12

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT03166254

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