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 Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma

Phase 1

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiation Therapy
Drug: Cisplatin

First Posted Date: 2016-05-03

Last Posted Date: 2021-03-12

Lead Sponsor: Vinita Takiar

Target Recruit Count: 9

Registration Number: NCT02759575

Locations: 🇺🇸
University of Cincinnati Medical Center, Cincinnati, Ohio, United States

Study of FAK (Defactinib) and PD-1 (Pembrolizumab) Inhibition in Advanced Solid Malignancies (FAK-PD1)

Phase 1

Conditions: Carcinoma, Non-small-cell Lung
Pancreatic Neoplasms
Mesothelioma

Interventions: Drug: Defactinib
Drug: Pembrolizumab

First Posted Date: 2016-05-02

Last Posted Date: 2018-03-19

Lead Sponsor: NHS Greater Glasgow and Clyde

Target Recruit Count: 59

Registration Number: NCT02758587

Locations: 🇬🇧
Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, United Kingdom
🇬🇧
Belfast Health and Social Care Trust, Cancer Centre, Lisburn Road, Belfast, United Kingdom
🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

and more 2 locations

A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Carcinoma Breast Stage IV

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Gemcitabine

First Posted Date: 2016-04-28

Last Posted Date: 2024-06-04

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 87

Registration Number: NCT02755272

Locations: 🇺🇸
Indiana University, Indianapolis, Indiana, United States
🇺🇸
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Washington University in St. Louis, Saint Louis, Missouri, United States

and more 3 locations

Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Nab-Paclitaxel

First Posted Date: 2016-04-27

Last Posted Date: 2024-03-06

Lead Sponsor: NYU Langone Health

Target Recruit Count: 70

Registration Number: NCT02752685

Locations: 🇺🇸
NYU Perlmutter Cancer Center, New York, New York, United States

Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Pembrolizumab
Drug: Ipilimumab

First Posted Date: 2016-04-19

Last Posted Date: 2024-05-14

Lead Sponsor: University of Chicago

Target Recruit Count: 70

Registration Number: NCT02743819

Locations: 🇺🇸
Oncology Specialists S.C., Park Ridge, Illinois, United States
🇺🇸
University of South Alabama, Mobile, Alabama, United States
🇺🇸
Mount Sinai Medical Center of Florida, Miami Beach, Florida, United States

and more 7 locations

Response to Pembrolizumab in Metastatic Melanoma: Computed Tomography Texture Analysis as a Predictive Biomarker

Phase 2

Terminated

Conditions: Metastatic Melanoma

Interventions: Drug: Pembrolizumab
Procedure: CT Scan

First Posted Date: 2016-04-15

Last Posted Date: 2023-08-25

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 9

Registration Number: NCT02740920

Locations: 🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada
🇨🇦
London Regional Cancer Program, London, Ontario, Canada
🇨🇦
Odette Cancer Centre, Toronto, Ontario, Canada

and more 2 locations

Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

Phase 1

Active, not recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Capecitabine

First Posted Date: 2016-04-12

Last Posted Date: 2024-02-22

Lead Sponsor: Providence Health & Services

Target Recruit Count: 29

Registration Number: NCT02734290

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Providence Cancer Center, Portland, Oregon, United States

Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2

Phase 2

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: pembrolizumab

First Posted Date: 2016-04-11

Last Posted Date: 2023-11-29

Lead Sponsor: University of Birmingham

Target Recruit Count: 62

Registration Number: NCT02733159

Locations: 🇬🇧
Maidstone and Tunbridge Wells NHS Trust, Maidstone, Kent, United Kingdom
🇬🇧
Southampton University Hospitals NHS Trust, Southampton, Hampshire, United Kingdom
🇬🇧
The Royal Marsden Hospital, London, United Kingdom

and more 7 locations

Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients

Phase 2

Completed

Conditions: Metastatic Triple Negative
Breast Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy

First Posted Date: 2016-04-06

Last Posted Date: 2022-10-19

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 17

Registration Number: NCT02730130

Locations: 🇺🇸
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic Cancers

Early Phase 1

Completed

Conditions: Gynecologic Neoplasms
Epithelial Ovarian Cancer
Uterine Endometrial Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-04-05

Last Posted Date: 2024-02-21

Lead Sponsor: AA Secord

Target Recruit Count: 39

Registration Number: NCT02728830

Locations: 🇺🇸
Duke Cancer Institute, Durham, North Carolina, United States

Drug Development Updates

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