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 in Intermediate Risk Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

Phase 1

Terminated

Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-05-25

Last Posted Date: 2020-07-31

Lead Sponsor: University of Oxford

Target Recruit Count: 6

Registration Number: NCT03167151

Locations: 🇬🇧
University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, United Kingdom
🇬🇧
Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom
🇬🇧
Royal Surrey County Hospital NHS Foundation Trust, Guildford, Surrey, United Kingdom

Pembrolizumab in Advanced Hepatocellular Carcinoma as Second-line Treatment After Failure of Sorafenib

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-05-23

Last Posted Date: 2022-08-08

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 60

Registration Number: NCT03163992

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Blinatumomab and Pembrolizumab for Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia With High Marrow Lymphoblasts

Phase 1

Active, not recruiting

Conditions: B-Cell Acute Lymphoblastic Leukemia, Adult

Interventions: Drug: blinatumomab
Drug: pembrolizumab

First Posted Date: 2017-05-19

Last Posted Date: 2023-08-24

Lead Sponsor: University of California, San Diego

Target Recruit Count: 16

Registration Number: NCT03160079

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
UCSF Comprehensive Cancer Center, San Francisco, California, United States
🇺🇸
UCSF Fresno Community Cancer Institute, Clovis, California, United States

and more 1 locations

Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Afatinib
Drug: pembrolizumab

First Posted Date: 2017-05-17

Last Posted Date: 2021-02-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 24

Registration Number: NCT03157089

Locations: 🇫🇷
HOP Côte de Nacre, Caen, France
🇫🇷
HOP Le Mans, Le Mans, France
🇺🇸
Baptist Health Medical Group, Lexington, Kentucky, United States

and more 10 locations

Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma

Interventions: Drug: Ibrutinib
Drug: Pembrolizumab

First Posted Date: 2017-05-15

Last Posted Date: 2024-11-19

Lead Sponsor: Joshua Brody

Target Recruit Count: 23

Registration Number: NCT03153202

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas

Early Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Cyclophosphamide
Drug: GVAX Pancreas Vaccine (GVAX)
Drug: Pembrolizumab
Drug: IMC-CS4

First Posted Date: 2017-05-15

Last Posted Date: 2024-11-29

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 12

Registration Number: NCT03153410

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

Phase 2

Active, not recruiting

Conditions: Metastatic Melanoma

Interventions: Drug: Pembrolizumab
Drug: Dabrafenib
Drug: Trametinib

First Posted Date: 2017-05-11

Last Posted Date: 2024-03-21

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 16

Registration Number: NCT03149029

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts general Hospital, Boston, Massachusetts, United States

Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma

Phase 1

Active, not recruiting

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Cabozantinib
Drug: Pembrolizumab

First Posted Date: 2017-05-11

Last Posted Date: 2024-02-06

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 45

Registration Number: NCT03149822

Locations: 🇺🇸
University of Colorado Denver, Aurora, Colorado, United States
🇺🇸
Highlands Ranch Hospital, Highlands Ranch, Colorado, United States
🇺🇸
Memorial Hospital Central, Colorado Springs, Colorado, United States

and more 2 locations

A Trial Using ctDNA Blood Tests to Detect Cancer Cells After Standard Treatment to Trigger Additional Treatment in Early Stage Triple Negative Breast Cancer Patients

Phase 2

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-05-09

Last Posted Date: 2022-02-24

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 208

Registration Number: NCT03145961

Locations: 🇬🇧
Royal Marsden Hospital, Sutton, Sutton, Surrey, United Kingdom
🇬🇧
St Bartholomew's Hospital, London, United Kingdom
🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

and more 14 locations

Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)

Phase 3

Active, not recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Placebo
Biological: Pembrolizumab

First Posted Date: 2017-05-05

Last Posted Date: 2024-11-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 994

Registration Number: NCT03142334

Locations: 🇦🇺
Fiona Stanley Hospital ( Site 0702), Murdoch, Western Australia, Australia
🇺🇸
Weinberg Cancer Institute at Franklin Square ( Site 0046), Baltimore, Maryland, United States
🇺🇸
Beth Israel Deaconess Medical Ctr. ( Site 0044), Boston, Massachusetts, United States

and more 248 locations

Drug Development Updates

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