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

CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)

Phase 1

Conditions: Solid Tumors
GI Cancer

Interventions: Drug: CGX1321
Drug: encorafenib
Drug: Pembrolizumab
Drug: cetuximab

First Posted Date: 2016-02-05

Last Posted Date: 2022-01-26

Lead Sponsor: Curegenix Inc.

Target Recruit Count: 72

Registration Number: NCT02675946

Locations: 🇺🇸
Edward H. Kaplan MD and Associates, Skokie, Illinois, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Memorial Care, Long Beach, California, United States

and more 22 locations

Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma

Phase 2

Active, not recruiting

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-02-03

Last Posted Date: 2024-03-26

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 39

Registration Number: NCT02673333

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Michigan (Data or Specimen Analysis Only), Ann Arbor, Michigan, United States

A Study of Anti-PD-1 (Pembrolizumab) Therapy in Metastatic Melanoma (ADAPTeM)

Phase 2

Withdrawn

Conditions: Advanced Melanoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-01-26

Last Posted Date: 2017-08-01

Lead Sponsor: Royal Marsden NHS Foundation Trust

Registration Number: NCT02663258

Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer

Phase 2

Active, not recruiting

Conditions: Bladder Cancer

Interventions: Drug: Pembrolizumab
Drug: Cisplatin
Radiation: Radiotherapy

First Posted Date: 2016-01-25

Last Posted Date: 2023-10-31

Lead Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Target Recruit Count: 28

Registration Number: NCT02662062

Locations: 🇦🇺
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
🇦🇺
Royal North Shore Hospital, St Leonards, New South Wales, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

and more 4 locations

A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Phase 1

Withdrawn

Conditions: Urothelial Cancer
Small Cell Lung Cancer
Non Small Cell Lung Cancer
Advanced Triple Negative Breast Cancer
Mesothelioma
Malignant Melanoma

Interventions: Drug: Pembrolizumab
Biological: CDX-1401
Biological: Poly-ICLC

First Posted Date: 2016-01-22

Last Posted Date: 2016-12-07

Lead Sponsor: Case Comprehensive Cancer Center

Registration Number: NCT02661100

Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions, in Previously Treated Patients With Stage IV NSCLC

Phase 2

Completed

Conditions: Stage IV Non-Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Radiation: Single Fraction Radiation Therapy

First Posted Date: 2016-01-18

Last Posted Date: 2024-05-03

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 13

Registration Number: NCT02658097

Locations: 🇺🇸
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-01-18

Last Posted Date: 2020-11-12

Lead Sponsor: Lynn Feun, MD

Target Recruit Count: 29

Registration Number: NCT02658019

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype

Not Applicable

Active, not recruiting

Conditions: Glioma
Recurrent Malignant Glioma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-01-18

Last Posted Date: 2024-12-06

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 27

Registration Number: NCT02658279

Locations: 🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 12 locations