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 + Paclitaxel in Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Non-luminal (by PAM50) Advanced Breast Cancer After Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Progression

Phase 2

Terminated

Conditions: Metastatic Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel

First Posted Date: 2020-01-31

Last Posted Date: 2024-06-07

Lead Sponsor: SOLTI Breast Cancer Research Group

Target Recruit Count: 20

Registration Number: NCT04251169

Locations: 🇪🇸
Hospital Quiron Salud Sagrado Corazon Sevilla, Sevilla, Spain
🇪🇸
Fundación Instituto Valenciano de Oncología, Valencia, Spain
🇪🇸
Hospital Clinic de Barcelona, Barcelona, Spain

and more 4 locations

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: Oral Placebo
Drug: Lenvatinib
Drug: IV Placebo
Biological: Pembrolizumab
Procedure: TACE

First Posted Date: 2020-01-29

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 450

Registration Number: NCT04246177

Locations: 🇺🇸
University of Cincinnati Medical Center ( Site 0791), Cincinnati, Ohio, United States
🇺🇸
The Ohio State University Wexner Medical Center ( Site 0759), Columbus, Ohio, United States
🇨🇳
Anhui Provincial Hospital ( Site 0092), Heifei, Anhui, China

and more 204 locations

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

Phase 3

Active, not recruiting

Conditions: Urinary Bladder Neoplasms

Interventions: Drug: Pembrolizumab
Radiation: Conventional Radiotherapy (Bladder only)
Radiation: Conventional Radiotherapy (Bladder and pelvic nodes)
Radiation: Hypofractionated Radiotherapy (Bladder only)
Drug: Cisplatin
Drug: Mitomycin C (MMC)
Drug: Fluorouracil (5-FU)
Drug: Placebo to Pembrolizumab
Drug: Gemcitabine

First Posted Date: 2020-01-27

Last Posted Date: 2024-11-25

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 520

Registration Number: NCT04241185

Locations: 🇭🇺
Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga ( Site 0095), Budapest, Hungary
🇺🇸
Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041), Washington, District of Columbia, United States
🇺🇸
Bay Pines VA Medical Center ( Site 0055), Bay Pines, Florida, United States

and more 123 locations

Carboplatin-Paclitaxel-Pembrolizumab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

Phase 2

Conditions: Locally Advanced Cervical Cancer

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Taxol

First Posted Date: 2020-01-23

Last Posted Date: 2021-08-27

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 45

Registration Number: NCT04238988

Locations: 🇮🇹
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

Phase 1

Terminated

Conditions: Melanoma
Thyroid Cancer
Renal Cell Carcinoma
Non Small Cell Lung Cancer
Small-cell Lung Cancer
Bladder Cancer
Merkel Cell Carcinoma
Skin Squamous Cell Carcinoma
Microsatellite Instability High
Triple Negative Breast Cancer

Interventions: Drug: Nanrilkefusp alfa
Drug: Pembrolizumab

First Posted Date: 2020-01-21

Last Posted Date: 2025-01-08

Lead Sponsor: SOTIO Biotech AG

Target Recruit Count: 115

Registration Number: NCT04234113

Locations: 🇫🇷
Institut Gustave Roussy, Paris, France
🇪🇸
University Hospital Sanchinarro, Madrid, Spain
🇫🇷
Hôpitaux Universitaires de Marseille Timone, Marseille, France

and more 9 locations

Sacituzumab Govitecan In TNBC

Phase 2

Recruiting

Conditions: ER-Negative Breast Cancer
HER2-negative Breast Cancer
Invasive Breast Cancer
Triple Negative Breast Cancer
PR-Negative Breast Cancer

Interventions: Drug: Sacituzumab Govitecan
Drug: Pembrolizumab

First Posted Date: 2020-01-18

Last Posted Date: 2024-03-19

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 260

Registration Number: NCT04230109

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital - North Shore Cancer Center, Danvers, Massachusetts, United States

and more 2 locations

Pembrolizumab in Early Stage Colon Cancer

Phase 2

Withdrawn

Conditions: Colon Cancer

Interventions: Procedure: Surgery
Drug: Pembrolizumab

First Posted Date: 2020-01-18

Last Posted Date: 2024-07-31

Lead Sponsor: University of Chicago

Registration Number: NCT04231526

Locations: 🇺🇸
University Of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Decatur Memorial Hospital, Decatur, Illinois, United States

Consolidation Pembrolizumab After Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Phase 2

Recruiting

Conditions: Nasopharyngeal Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Placebo

First Posted Date: 2020-01-13

Last Posted Date: 2024-05-30

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 112

Registration Number: NCT04227509

Locations: 🇰🇷
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, Republic of

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Phase 2

Active, not recruiting

Conditions: Locally Advanced or Metastatic Malignant Solid Tumors

Interventions: Drug: enfortumab vedotin
Drug: pembrolizumab

First Posted Date: 2020-01-13

Last Posted Date: 2024-12-09

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 320

Registration Number: NCT04225117

Locations: 🇯🇵
Site JP81004, Nagoya, Aichi, Japan
🇯🇵
Site JP81001, Kashiwa, Chiba, Japan
🇯🇵
Site JP81005, Chuo-ku, Osaka, Japan

and more 34 locations

Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer

Phase 2

Completed

Conditions: Penile Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Standard of care therapy

First Posted Date: 2020-01-13

Last Posted Date: 2024-03-13

Lead Sponsor: Latin American Cooperative Oncology Group

Target Recruit Count: 37

Registration Number: NCT04224740

Locations: 🇧🇷
ICC - Instituto do Câncer do Ceará, Fortaleza, Ceará, Brazil
🇧🇷
Oncocentro Ceará (Rede D'or), Fortaleza, Ceará, Brazil
🇧🇷
ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil

and more 8 locations

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