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

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

Phase 1

Completed

Conditions: Breast Cancer
Gastric Cancer
Fallopian Tube Cancer
Other Solid Tumors
Indolent B-cell Lymphomas
Waldenstrom's Disease
Marginal Zone Lymphoma
Pancreatic Adenocarcinoma
Esophageal Cancer
Primary Peritoneal Cancer

Interventions: Drug: CDX-1140
Drug: CDX-301
Drug: Chemotherapy
Drug: pembrolizumab

First Posted Date: 2017-11-06

Last Posted Date: 2024-03-28

Lead Sponsor: Celldex Therapeutics

Target Recruit Count: 132

Registration Number: NCT03329950

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Houston Methodist, Houston, Texas, United States
🇺🇸
Northside Hospital, Inc., Atlanta, Georgia, United States

and more 8 locations

Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal Cancers

Phase 1

Completed

Conditions: Colorectal Carcinoma
Colon Cancer
Colorectal Cancer
Colon Disease

Interventions: Drug: Pembrolizumab
Drug: Ibrutinib

First Posted Date: 2017-11-06

Last Posted Date: 2022-06-03

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 40

Registration Number: NCT03332498

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck

Phase 2

Withdrawn

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Pembrolizumab
Drug: Epacadostat

First Posted Date: 2017-10-30

Last Posted Date: 2019-04-22

Lead Sponsor: University of Chicago

Registration Number: NCT03325465

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Epacadostat
Drug: Platinum-based chemotherapy
Drug: Placebo

First Posted Date: 2017-10-26

Last Posted Date: 2022-01-24

Lead Sponsor: Incyte Corporation

Target Recruit Count: 233

Registration Number: NCT03322566

Locations: 🇦🇺
Chris OBrien Lifehouse, Camperdown, New South Wales, Australia
🇺🇸
St. Vincent Healthcare Frontier Cancer Center, Billings, Montana, United States
🇭🇺
Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, Hungary

and more 90 locations

Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Epacadostat
Drug: Placebo

First Posted Date: 2017-10-26

Last Posted Date: 2022-01-24

Lead Sponsor: Incyte Corporation

Target Recruit Count: 154

Registration Number: NCT03322540

Locations: 🇺🇸
Anne Arundel Health System Research Institute, Annapolis, Maryland, United States
🇺🇸
Maryland Oncology Hematology, P.A., Rockville, Maryland, United States
🇺🇸
Nebraska Cancer Specialists, Omaha, Nebraska, United States

and more 96 locations

Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence

Phase 2

Active, not recruiting

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-10-26

Last Posted Date: 2024-12-19

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 26

Registration Number: NCT03322267

Locations: 🇨🇳
National Taiwan University Hospital, Taipei City, Taiwan

A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies

Phase 2

Completed

Conditions: Gastric Cancer
GastroEsophageal Cancer

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2017-10-25

Last Posted Date: 2024-03-27

Lead Sponsor: NYU Langone Health

Target Recruit Count: 24

Registration Number: NCT03321630

Locations: 🇺🇸
The Mount Sinai Hospital, New York, New York, United States
🇺🇸
NYU Langone Health, New York, New York, United States

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Phase 1

Active, not recruiting

Conditions: Small Cell Lung Carcinoma

Interventions: Drug: Tarlatamab
Drug: CRS Mitigation Strategies
Drug: Pembrolizumab

First Posted Date: 2017-10-24

Last Posted Date: 2024-12-13

Lead Sponsor: Amgen

Target Recruit Count: 269

Registration Number: NCT03319940

Locations: 🇺🇸
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic, Columbus, Ohio, United States
🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
🇦🇹
Landeskrankenhaus Salzburg, Salzburg, Austria

and more 36 locations

Study of Pembrolizumab and Radiotherapy in Liver Cancer

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab
Radiation: Stereotactic Body Radiotherapy (SBRT)

First Posted Date: 2017-10-20

Last Posted Date: 2024-04-18

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 19

Registration Number: NCT03316872

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Pembrolizumab in Neoplasms or Lymphomas

Phase 2

Suspended

Conditions: Lymphoma
Histiocytic Sarcoma
Follicular Dendritic Cell Sarcoma
Interdigitating Dendritic Cell Sarcoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-10-20

Last Posted Date: 2025-01-03

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 18

Registration Number: NCT03316573

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 1 locations

Drug Development Updates

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