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

Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers

Phase 2

Recruiting

Conditions: Adenoid Cystic Carcinoma
Salivary Gland Cancer

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2019-12-24

Last Posted Date: 2024-08-20

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 64

Registration Number: NCT04209660

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Baptist Alliance MCI, Miami, Florida, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 5 locations

A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma Stage III

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2019-12-20

Last Posted Date: 2024-02-14

Lead Sponsor: Melanoma Institute Australia

Target Recruit Count: 21

Registration Number: NCT04207086

Locations: 🇦🇺
Melanoma Institute Australia, North Sydney, New South Wales, Australia

ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors

Phase 1

Active, not recruiting

Conditions: Melanoma
Ovary Cancer
Cancer
Pancreatic Cancer
Solid Tumor

Interventions: Drug: ENB003
Drug: Pembrolizumab

First Posted Date: 2019-12-19

Last Posted Date: 2023-06-15

Lead Sponsor: ENB Therapeutics, Inc

Target Recruit Count: 137

Registration Number: NCT04205227

Locations: 🇦🇺
Kinghorn-St Vincent's Hospital, Darlinghurst, New South Wales, Australia
🇦🇺
Blacktown Oncology, Blacktown, New South Wales, Australia
🇺🇸
Cedars Sinai-The Angeles Clinic, Los Angeles, California, United States

and more 2 locations

Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma

Phase 1

Recruiting

Conditions: Recurrent Glioblastoma

Interventions: Biological: Dendritic Cell Tumor Cell Lysate Vaccine
Other: Placebo Administration
Biological: Pembrolizumab
Drug: Poly ICLC

First Posted Date: 2019-12-17

Last Posted Date: 2024-10-16

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 40

Registration Number: NCT04201873

Locations: 🇺🇸
Quan, Los Angeles, California, United States

Pembrolizumab + Defactinib In Pleural Mesothelioma

Phase 1

Withdrawn

Conditions: Malignant Pleural Mesothelioma

Interventions: Drug: Pembrolizumab
Drug: Defactinib

First Posted Date: 2019-12-17

Last Posted Date: 2020-11-17

Lead Sponsor: Raphael Bueno, MD

Registration Number: NCT04201145

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Pembrolizumab With Axitinib in Recurrent Endometrial Cancer

Phase 2

Withdrawn

Conditions: Recurrent Endometrial Cancer

Interventions: Drug: Pembrolizumab
Drug: Axitinib

First Posted Date: 2019-12-13

Last Posted Date: 2020-11-05

Lead Sponsor: Case Comprehensive Cancer Center

Registration Number: NCT04197219

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)

Phase 3

Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Lenvatinib
Drug: Placebo
Biological: Pembrolizumab

First Posted Date: 2019-12-13

Last Posted Date: 2025-01-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 511

Registration Number: NCT04199104

Locations: 🇨🇦
Princess Margaret Cancer Centre ( Site 0200), Toronto, Ontario, Canada
🇺🇸
University of Connecticut Health Center ( Site 0020), Farmington, Connecticut, United States
🇺🇸
Dana Farber Cancer Institute ( Site 0019), Boston, Massachusetts, United States

and more 149 locations

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Phase 3

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Selpercatinib
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed
Drug: Pembrolizumab

First Posted Date: 2019-12-11

Last Posted Date: 2024-06-20

Lead Sponsor: Loxo Oncology, Inc.

Target Recruit Count: 261

Registration Number: NCT04194944

Locations: 🇨🇳
The First Affiated Hospital Of Guangzhou Medical Collage, Guangzhou, Guangzhou, China
🇦🇷
Alexander Fleming, Ciudad de Buenos Aires, Argentina
🇨🇳
Buddhist Dalin Tzu Chi General Hospital, Dalin Town, Chiayi, Taiwan

and more 191 locations

Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

Phase 2

Active, not recruiting

Conditions: Triple Negative Breast Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Carboplatin
Drug: Olaparib
Drug: Gemcitabine

First Posted Date: 2019-12-09

Last Posted Date: 2024-11-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 462

Registration Number: NCT04191135

Locations: 🇺🇸
University of Chicago ( Site 0159), Chicago, Illinois, United States
🇬🇧
Raigmore Hospital ( Site 0915), Inverness, Highland, United Kingdom
🇺🇦
Zhytomyr Regional Oncology Center ( Site 1515), Zhytomyr, Zhytomyrska Oblast, Ukraine

and more 119 locations

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Phase 3

Active, not recruiting

Conditions: Metastatic Hormone-Sensitive Prostate Cancer

Interventions: Biological: Pembrolizumab
Drug: Enzalutamide
Drug: Androgen Deprivation Therapy (ADT)
Other: Placebo

First Posted Date: 2019-12-09

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1251

Registration Number: NCT04191096

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0241), Los Angeles, California, United States
🇲🇽
Grupo Medico Camino SC ( Site 2613), Mexico City, Mexico
🇩🇪
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210), Muenchen, Bayern, Germany

and more 210 locations

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