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 And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Phase 1

Recruiting

Conditions: Brain Metastases
Metastatic Breast Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-02-28

Last Posted Date: 2024-05-22

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 41

Registration Number: NCT03449238

Locations: 🇺🇸
Brooklyn Methodist Hospital - NewYork Presbyterian, New York, New York, United States
🇺🇸
Weill Cornell Medicine, New York, New York, United States
🇺🇸
New York Presbyterian Hospital - Queens, New York, New York, United States

Pembrolizumab in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors.

Phase 2

Conditions: Non Small Cell Lung Cancer (NSCLC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-02-27

Last Posted Date: 2021-06-09

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 65

Registration Number: NCT03447678

Locations: 🇮🇹
National Cancer Institute, Milan, Italy

Study of a Combination of GSK1795091 and Immunotherapies in Subjects With Advanced Solid Tumors

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: GSK1795091
Drug: GSK3359609
Drug: GSK3174998
Drug: Pembrolizumab

First Posted Date: 2018-02-27

Last Posted Date: 2023-05-03

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 54

Registration Number: NCT03447314

Locations: 🇪🇸
GSK Investigational Site, Barcelona, Spain

Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults

Early Phase 1

Completed

Conditions: Childhood Lymphoma
Relapsed Cancer
Refractory Cancer
Adult Lymphoma
Childhood Solid Tumor
Adult Solid Tumor

Interventions: Drug: Pembrolizumab
Drug: Decitabine
Radiation: Hypofractionated Index Site Radiation

First Posted Date: 2018-02-26

Last Posted Date: 2024-07-10

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 22

Registration Number: NCT03445858

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

PembRolIzuMab and Stereotactic Body Radiotherapy In Metastatic Non-small-cell lunG Cancer Patients

Phase 1

Terminated

Conditions: Metastatic Non-small-cell lunG Cancer

Interventions: Radiation: Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)
Radiation: Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#)
Radiation: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose
Drug: Pembrolizumab

First Posted Date: 2018-02-19

Last Posted Date: 2022-09-09

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 2

Registration Number: NCT03436056

Locations: 🇬🇧
Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

Pembrolizumab with Intratumoral Injection of Clostridium Novyi-NT

Phase 1

Active, not recruiting

Conditions: Malignant Neoplasm of Breast
Malignant Neoplasms of Digestive Organs
Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
Malignant Neoplasms of Female Genital Organs
Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites
Malignant Neoplasms of Independent (primary) Multiple Sites
Malignant Neoplasms of Lip Oral Cavity and Pharynx
Malignant Neoplasms of Male Genital Organs
Malignant Neoplasms of Mesothelial and Soft Tissue
Malignant Neoplasms of Respiratory and Intrathoracic Organs

Interventions: Drug: Pembrolizumab
Biological: Clostridium Novyi-NT
Drug: Doxycycline

First Posted Date: 2018-02-19

Last Posted Date: 2024-10-31

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT03435952

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer

Phase 2

Active, not recruiting

Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-02-13

Last Posted Date: 2023-01-30

Lead Sponsor: University College, London

Target Recruit Count: 28

Registration Number: NCT03430700

Locations: 🇬🇧
UCLH, London, United Kingdom
🇬🇧
Churchill Hospital, Oxford, United Kingdom
🇬🇧
Barts, London, United Kingdom

and more 1 locations

Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma

Phase 1

Completed

Conditions: Glioblastoma
GBM
Brain Tumor

Interventions: Drug: Pembrolizumab
Drug: Vorinostat
Drug: Temozolomide
Radiation: Radiotherapy

First Posted Date: 2018-02-08

Last Posted Date: 2023-07-19

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 21

Registration Number: NCT03426891

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer

Phase 2

Active, not recruiting

Conditions: Clear Cell Tumor
Gynecologic Cancer
Advanced Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-02-07

Last Posted Date: 2024-04-12

Lead Sponsor: University College, London

Target Recruit Count: 48

Registration Number: NCT03425565

Locations: 🇬🇧
University College Hospital, London, United Kingdom
🇬🇧
Western General Hospital, Edinburgh, United Kingdom
🇬🇧
The Christie Hospital, Manchester, United Kingdom

and more 2 locations

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

Phase 3

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Biological: Pembrolizumab
Drug: Placebo
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed

First Posted Date: 2018-02-07

Last Posted Date: 2024-12-03

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 797

Registration Number: NCT03425643

Locations: 🇺🇸
UPMC Hillman Cancer Centers ( Site 0041), Pittsburgh, Pennsylvania, United States
🇺🇸
PPG-Oncology ( Site 0043), Fort Wayne, Indiana, United States
🇺🇸
Ingalls Memorial Hospital ( Site 0044), Harvey, Illinois, United States

and more 224 locations

Drug Development Updates

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