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 Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)

Phase 3

Active, not recruiting

Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Neoplasms

Interventions: Drug: Placebo for pembrolizumab
Biological: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Olaparib
Drug: Placebo for olaparib
Biological: Bevacizumab
Drug: Docetaxel

First Posted Date: 2018-11-14

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1367

Registration Number: NCT03740165

Locations: 🇺🇸
The Bing Cancer Center ( Site 0044), Columbus, Ohio, United States
🇺🇸
Parkland Hospital ( Site 0081), Dallas, Texas, United States
🇺🇸
UT Southwestern Medical Center ( Site 0046), Dallas, Texas, United States

and more 224 locations

A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer

Phase 1

Terminated

Conditions: Gastroesophageal Junction Adenocarcinoma
Carcinoma, Squamous Cell of Head and Neck
Gastric Adenocarcinoma
Non-small Cell Lung Cancer

Interventions: Biological: ilixadencel
Drug: Pembrolizumab

First Posted Date: 2018-11-08

Last Posted Date: 2022-03-16

Lead Sponsor: Mendus

Target Recruit Count: 21

Registration Number: NCT03735290

Locations: 🇺🇸
Site 1010, Coral Gables, Florida, United States
🇺🇸
Site 1006, Iowa City, Iowa, United States
🇺🇸
Site 1011, Louisville, Kentucky, United States

and more 2 locations

Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer

Phase 1

Recruiting

Conditions: Ovarian Cancer Recurrent

Interventions: Drug: Rintatolimod
Drug: Pembrolizumab
Drug: Cisplatin

First Posted Date: 2018-11-08

Last Posted Date: 2024-06-05

Lead Sponsor: Robert Edwards

Target Recruit Count: 45

Registration Number: NCT03734692

Locations: 🇺🇸
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer

Phase 2

Active, not recruiting

Conditions: NPC

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-11-08

Last Posted Date: 2024-02-07

Lead Sponsor: CCTU

Target Recruit Count: 46

Registration Number: NCT03734809

Locations: 🇸🇬
National Cancer Centre of Singapore, Singapore, Singapore
🇭🇰
Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, Hong Kong

Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type

Phase 2

Active, not recruiting

Conditions: NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis)
NK/T-Cell Lymphoma of Nasopharynx (Diagnosis)

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-11-02

Last Posted Date: 2024-12-13

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 19

Registration Number: NCT03728972

Locations: 🇺🇸
Md Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Hackensack Meridian Health, Hackensack, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 7 locations

Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma

Phase 2

Recruiting

Conditions: Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Pembrolizumab
Drug: Defactinib

First Posted Date: 2018-11-01

Last Posted Date: 2024-01-24

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 36

Registration Number: NCT03727880

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
Samuel Oschin Cancer Center at Cedars-Sinai, Los Angeles, California, United States

Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India (MK-3475-593/KEYNOTE-593)

Phase 4

Completed

Conditions: Carcinoma, Non-Small-Cell Lung
Melanoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-10-23

Last Posted Date: 2024-08-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 150

Registration Number: NCT03715205

Locations: 🇮🇳
Indraprastha Apollo Hospitals ( Site 0008), New Delhi, Delhi, India
🇮🇳
All India Institute of Medical Sciences ( Site 0012), New Delhi, Delhi, India
🇮🇳
Nizam's Institute of Medical Sciences ( Site 0011), Hyderabad, Andhra Pradesh, India

and more 5 locations

Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

Phase 3

Completed

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: lenvatinib
Drug: saline placebo
Biological: pembrolizumab

First Posted Date: 2018-10-22

Last Posted Date: 2024-10-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 794

Registration Number: NCT03713593

Locations: 🇺🇸
Emory University Winship Cancer Institute ( Site 0639), Atlanta, Georgia, United States
🇺🇸
Beth Israel Deaconess Medical Center ( Site 0716), Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital ( Site 0603), Boston, Massachusetts, United States

and more 169 locations

Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Trial

Phase 3

Active, not recruiting

Conditions: Pathologic Stage I Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage II Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8

Interventions: Procedure: Biospecimen Collection
Other: Best Practice
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Radiation: Radiation Therapy

First Posted Date: 2018-10-19

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 280

Registration Number: NCT03712605

Locations: 🇺🇸
MGC Hematology Oncology-Union, Union, South Carolina, United States
🇺🇸
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
🇺🇸
Illinois CancerCare-Carthage, Carthage, Illinois, United States

and more 554 locations

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Phase 3

Active, not recruiting

Conditions: High-risk Non-muscle Invasive Bladder Cancer

Interventions: Biological: BCG
Biological: Pembrolizumab

First Posted Date: 2018-10-18

Last Posted Date: 2024-12-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1397

Registration Number: NCT03711032

Locations: 🇯🇵
Institute of Science Tokyo Hospital ( Site 0409), Tokyo, Japan
🇺🇸
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083), Anchorage, Alaska, United States
🇺🇸
Mayo Clinic in Arizona - Phoenix ( Site 1094), Phoenix, Arizona, United States

and more 203 locations

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