Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

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)

Clinical Trials

ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 1

Completed

Conditions: Prostate Cancer
Cancer

Interventions: Drug: ADXS31-142
Drug: Pembrolizumab

First Posted Date: 2014-12-25

Last Posted Date: 2024-04-02

Lead Sponsor: Advaxis, Inc.

Target Recruit Count: 50

Registration Number: NCT02325557

Locations: 🇺🇸
Recruiting, Providence, Rhode Island, United States
🇺🇸
Recrutiing, Philadelphia, Pennsylvania, United States
🇺🇸
University of Colorado Health Sciences Center (UCHSC), Aurora, Colorado, United States

and more 1 locations

Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer

Phase 1

Terminated

Conditions: Breast Cancer
Advanced Cancer
Colorectal Cancer
Gastric Cancer
Esophageal Cancer

Interventions: Drug: Pembrolizumab
Drug: ado-trastuzumab emtansine
Drug: Cetuximab
Drug: Trastuzumab

First Posted Date: 2014-12-17

Last Posted Date: 2019-10-21

Lead Sponsor: Western Regional Medical Center

Target Recruit Count: 16

Registration Number: NCT02318901

Locations: 🇺🇸
Western Regional Medical Center/Cancer Treatment Center of America, Goodyear, Arizona, United States

Radiation Therapy and MK-3475 for Patients With Recurrent/Metastatic Head and Neck Cancer, Renal Cell Cancer, Melanoma, and Lung Cancer

Phase 1

Completed

Conditions: Metastatic Renal Cell Cancer
Recurrent Renal Cell Carcinoma
Stage IV Lung Cancer
Head and Neck Squamous Cell Carcinoma
Stage III Renal Cell Cancer
Stage IV Skin Melanoma
Recurrent Head and Neck Carcinoma
Recurrent Lung Carcinoma
Recurrent Skin Carcinoma

Interventions: Radiation: Radiation Therapy (RT)
Drug: MK-3475

First Posted Date: 2014-12-17

Last Posted Date: 2025-05-15

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 41

Registration Number: NCT02318771

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Oligometastatic Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2014-12-12

Last Posted Date: 2025-01-22

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 51

Registration Number: NCT02316002

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab for Recurrent High Grade Gliomas

Phase 1

Completed

Conditions: Malignant Glioma

Interventions: Radiation: Hypofractionated Stereotactic Irradiation (HFSRT)
Drug: Pembrolizumab
Drug: Bevacizumab

First Posted Date: 2014-12-10

Last Posted Date: 2023-10-23

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

Target Recruit Count: 32

Registration Number: NCT02313272

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

Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide

Phase 2

Active, not recruiting

Conditions: Recurrent Prostate Carcinoma
Hormone-Resistant Prostate Cancer
Stage IV Prostate Adenocarcinoma Cancer AJCC v8
Castration-Resistant Prostate Carcinoma
PSA Progression

Interventions: Drug: Enzalutamide
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab

First Posted Date: 2014-12-09

Last Posted Date: 2025-03-13

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 58

Registration Number: NCT02312557

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma

Phase 2

Completed

Conditions: Melanoma
Unresectable Malignant Neoplasm
Metastatic Melanoma
Stage IV Melanoma
Stage III Melanoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2014-12-03

Last Posted Date: 2019-06-20

Lead Sponsor: St. Louis University

Target Recruit Count: 10

Registration Number: NCT02306850

Locations: 🇺🇸
Saint Louis University Hospital, Saint Louis, Missouri, United States

Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer

Phase 1

Conditions: Pancreatic Cancer

Interventions: Drug: Pembrolizumab
Radiation: Neoadjuvant Chemoradiation

First Posted Date: 2014-12-02

Last Posted Date: 2021-08-13

Lead Sponsor: Craig L Slingluff, Jr

Target Recruit Count: 68

Registration Number: NCT02305186

Locations: 🇺🇸
Hartford HealthCare, Hartford, Connecticut, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Mayo Clinic Cancer Center, Phoenix, Arizona, United States

and more 3 locations