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

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

Phase 2

Recruiting

Conditions: Bladder Cancer

Interventions: Biological: Pembrolizumab
Biological: Pembrolizumab/vibostolimab coformulation
Biological: Favezelimab/pembrolizumab coformulation

First Posted Date: 2015-12-09

Last Posted Date: 2024-11-25

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 320

Registration Number: NCT02625961

Locations: 🇺🇸
Call for Information (Investigational Site 0083), Los Angeles, California, United States
🇺🇸
Call for Information (Investigational Site 0021), Orange, California, United States
🇺🇸
Call for Information (Investigational Site 0085), Chicago, Illinois, United States

and more 22 locations

Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

Phase 1

Completed

Conditions: Pancreatic Adenocarcinoma

First Posted Date: 2015-12-03

Last Posted Date: 2018-09-13

Lead Sponsor: Oncolytics Biotech

Target Recruit Count: 11

Registration Number: NCT02620423

Locations: 🇺🇸
Cancer Therapy & Research Center at UTHSCSA, San Antonio, Texas, United States

A Prospective Randomized and Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab

Phase 2

Suspended

Conditions: Melanoma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Biological: young TIL
Drug: Pembrolizumab

First Posted Date: 2015-12-03

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT02621021

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder

Phase 2

Active, not recruiting

Conditions: Muscle-invasive Urothelial Cancer of the Bladder

Interventions: Biological: Pembrolizumab
Procedure: Transurethral Resection of Bladder Tumor
Drug: Gemcitabine
Radiation: External Beam Radiation Therapy

First Posted Date: 2015-12-03

Last Posted Date: 2024-10-28

Lead Sponsor: NYU Langone Health

Target Recruit Count: 60

Registration Number: NCT02621151

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
NYU Perlmutter Cancer Center, New York, New York, United States
🇺🇸
Memorial Sloan Kettering, New York, New York, United States

and more 2 locations

Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma

Phase 1

Completed

Conditions: Renal Cell Carcinoma
Urinary Bladder Neoplasms

Interventions: Drug: Pembrolizumab
Drug: Vorinostat

First Posted Date: 2015-12-02

Last Posted Date: 2024-11-18

Lead Sponsor: Nabil Adra

Target Recruit Count: 52

Registration Number: NCT02619253

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Indiana University Hospital, Indianapolis, Indiana, United States
🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

and more 1 locations

Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma

Phase 2

Active, not recruiting

Conditions: Metastatic Malignant Melanoma

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2015-12-01

Last Posted Date: 2021-02-18

Lead Sponsor: Wilson Miller

Target Recruit Count: 30

Registration Number: NCT02617849

Locations: 🇨🇦
Jewish General Hospital, Montreal, Quebec, Canada
🇨🇦
Hopital Notre-Dame, Montreal, Quebec, Canada

A Study of Pembrolizumab With Standard Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2015-11-20

Last Posted Date: 2022-03-23

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 21

Registration Number: NCT02608684

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin

Phase 2

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: Pembrolizumab
Radiation: Intensity Modulated Radiation Therapy

First Posted Date: 2015-11-20

Last Posted Date: 2024-11-05

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 29

Registration Number: NCT02609503

Locations: 🇺🇸
John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States