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

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Phase 3

Recruiting

Conditions: Solid Tumors
Hematologic Malignancies

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib
Drug: Standard of Care (SOC)

First Posted Date: 2018-04-03

Last Posted Date: 2024-12-30

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 3500

Registration Number: NCT03486873

Locations: 🇧🇷
Lacks - Oncologia E Hematologia ( Site 1026), Pelotas, Rio Grande Do Sul, Brazil
🇨🇦
McGill University Health Centre ( Site 2818), Montreal, Quebec, Canada
🇨🇳
The Fifth Medical Center Of The Chinese PLA General Hospital (South) ( Site 3465), Beijing, Beijing, China

and more 613 locations

Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

Phase 2

Recruiting

Conditions: Colorectal Neoplasms
Exocrine Pancreatic Cancer
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell of Head and Neck

Interventions: Drug: tisotumab vedotin
Drug: pembrolizumab
Drug: carboplatin
Drug: cisplatin

First Posted Date: 2018-04-02

Last Posted Date: 2024-11-13

Lead Sponsor: Seagen Inc.

Target Recruit Count: 692

Registration Number: NCT03485209

Locations: 🇺🇸
Shands Cancer Center / University of Florida, Gainesville, Florida, United States
🇺🇸
Mayo Clinic Florida, Jacksonville, Florida, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

and more 69 locations

Anti-PD-1 Antibody With HD IL-2 in Metastatic Melanoma

Phase 2

Terminated

Conditions: Melanoma

Interventions: Drug: Pembrolizumab
Drug: Interleukin-2

First Posted Date: 2018-03-23

Last Posted Date: 2024-10-02

Lead Sponsor: Ralph Hauke

Target Recruit Count: 1

Registration Number: NCT03476174

Locations: 🇺🇸
Nebraska Cancer Specialists, Omaha, Nebraska, United States

Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Colorectal Cancer
Metastatic Cancer

Interventions: Drug: Pembrolizumab
Drug: Bevacizumab
Drug: Binimetinib

First Posted Date: 2018-03-23

Last Posted Date: 2024-02-28

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 53

Registration Number: NCT03475004

Locations: 🇺🇸
Universtiy of Colorado, Aurora, Colorado, United States

UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade

Phase 1

Recruiting

Conditions: Metastatic Melanoma
Head and Neck Squamous Cell Carcinoma
Metastatic Renal Cell Carcinoma
Non Small Cell Lung Cancer

Interventions: Drug: IL-2
Drug: Pembrolizumab
Radiation: Radiotherapy

First Posted Date: 2018-03-22

Last Posted Date: 2023-04-10

Lead Sponsor: Megan Daly, MD

Target Recruit Count: 45

Registration Number: NCT03474497

Locations: 🇺🇸
UC Davis Medical Center, Sacramento, California, United States
🇺🇸
University of California Davis Medical Center, Sacramento, California, United States

Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma

Phase 2

Conditions: Kaposi Sarcoma
Progression, Disease

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-03-19

Last Posted Date: 2019-10-21

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 17

Registration Number: NCT03469804

Locations: 🇫🇷
Saint-Louis Hospital, Paris, France

Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Head and Neck Carcinoma
Paranasal Sinus Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7

Interventions: Drug: Cabozantinib
Biological: Pembrolizumab

First Posted Date: 2018-03-16

Last Posted Date: 2024-12-27

Lead Sponsor: Emory University

Target Recruit Count: 36

Registration Number: NCT03468218

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States

Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy

Phase 2

Terminated

Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Epacadostat

First Posted Date: 2018-03-13

Last Posted Date: 2020-01-27

Lead Sponsor: University of Chicago

Target Recruit Count: 2

Registration Number: NCT03463161

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

Pembrolizumab and Sunitinib Malate in Treating Participants with Refractory Metastatic or Unresectable Thymic Cancer

Phase 2

Recruiting

Conditions: Thymic Carcinoma

Interventions: Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Drug: Sunitinib Malate

First Posted Date: 2018-03-13

Last Posted Date: 2024-11-04

Lead Sponsor: Dwight Owen

Target Recruit Count: 30

Registration Number: NCT03463460

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Indiana University, Indianapolis, Indiana, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition

Completed

Conditions: Metastatic Cancer

Interventions: Radiation: Radiotherapy
Drug: Nivolumab
Drug: Ipilimumab
Drug: Pembrolizumab

First Posted Date: 2018-03-05

Last Posted Date: 2023-02-16

Lead Sponsor: University of Erlangen-Nürnberg Medical School

Target Recruit Count: 150

Registration Number: NCT03453892

Locations: 🇩🇪
Department of Radiation Oncology, Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany

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