MedPath

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
-

Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma

Phase 2
Active, not recruiting
Conditions
Glioblastoma
Interventions
Drug: Pembrolizumab
Drug: Bevacizumab
Radiation: Re-irradiation
First Posted Date
2018-09-07
Last Posted Date
2024-07-03
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
60
Registration Number
NCT03661723
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Columbia University / Herbert Irving Comprehensive Cancer Center, New York, New York, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 2 locations

PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr)

Phase 1
Completed
Conditions
Metastatic Castration Resistant Prostate Cancer
Interventions
Drug: Pembrolizumab
Drug: 177Lu-PSMA
First Posted Date
2018-09-05
Last Posted Date
2023-07-28
Lead Sponsor
Peter MacCallum Cancer Centre, Australia
Target Recruit Count
37
Registration Number
NCT03658447
Locations
🇦🇺

Box Hill Hospital, Melbourne, Victoria, Australia

🇦🇺

Chris O'Brien Lifehouse, Sydney, New South Wales, Australia

🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

and more 1 locations

Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

Phase 1
Active, not recruiting
Conditions
Colorectal Cancer
Colorectal Cancer Metastatic
Interventions
First Posted Date
2018-09-05
Last Posted Date
2024-10-10
Lead Sponsor
University of Southern California
Target Recruit Count
75
Registration Number
NCT03657641
Locations
🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Phase 1
Active, not recruiting
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
Drug: Ramucirumab
Drug: Pembrolizumab
Procedure: Peripheral blood
Other: EORTC QLQ-30
Other: FACT H&N
First Posted Date
2018-08-29
Last Posted Date
2024-12-27
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
43
Registration Number
NCT03650764
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Ph I/II Trial of Systemic VSV-IFNβ-NIS in Combination with Checkpoint Inhibitor Therapy in Patients with Select Solid Tumors

Phase 1
Recruiting
Conditions
Solid Tumor
Non Small Cell Lung Cancer
Neuroendocrine Carcinoma
Renal Cell Carcinoma (RCC)
Interventions
Biological: VSV-IFNβ-NIS
Biological: ipilimumab + nivolumab
Biological: Pembrolizumab
First Posted Date
2018-08-27
Last Posted Date
2024-12-27
Lead Sponsor
Vyriad, Inc.
Target Recruit Count
86
Registration Number
NCT03647163
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Phase 2
Recruiting
Conditions
Squamous Cell Carcinoma of the Head and Neck
Metastatic Melanoma
Non-small Cell Lung Cancer
Interventions
Biological: LN-145
Biological: Lifileucel
Biological: LN-145-S1
Drug: Pembrolizumab
Drug: Ipilimumab
Drug: Nivolumab
First Posted Date
2018-08-24
Last Posted Date
2024-04-08
Lead Sponsor
Iovance Biotherapeutics, Inc.
Target Recruit Count
178
Registration Number
NCT03645928
Locations
🇺🇸

University of Colorado, Denver, Colorado, United States

🇬🇧

The Royal Marsden NHS Foundation Trust, London, England, United Kingdom

🇺🇸

University of Southern California, Los Angeles, California, United States

and more 42 locations

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer

Phase 2
Active, not recruiting
Conditions
Triple-negative Breast Cancer
Interventions
First Posted Date
2018-08-21
Last Posted Date
2024-04-11
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
120
Registration Number
NCT03639948
Locations
🇺🇸

The University of Kansas Cancer Center, Overland Park Clinic, Overland Park, Kansas, United States

🇺🇸

Texas Oncology- Baylor, Dallas, Texas, United States

🇺🇸

The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States

and more 6 locations

Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study

Phase 2
Recruiting
Conditions
Stage I Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
Stage IIA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Lung Non-Small Cell Carcinoma
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IB Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Interventions
Biological: Pembrolizumab
Other: Quality-of-Life Assessment
Procedure: Computed Tomography
Procedure: Biospecimen Collection
First Posted Date
2018-08-16
Last Posted Date
2024-12-12
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
48
Registration Number
NCT03634241
Locations
🇺🇸

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine

Phase 1
Completed
Conditions
Non-small Cell Lung Cancer
Urothelial Carcinoma
Squamous Cell Carcinoma of the Head and Neck
Cutaneous Melanoma
Renal Cell Carcinoma
Interventions
Biological: GEN-009 Adjuvanted Vaccine
Drug: Nivolumab
Drug: Pembrolizumab
First Posted Date
2018-08-16
Last Posted Date
2022-04-19
Lead Sponsor
Genocea Biosciences, Inc.
Target Recruit Count
24
Registration Number
NCT03633110
Locations
🇺🇸

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

John Wayne Cancer Institute - Providence Saint John's Health Center, Santa Monica, California, United States

🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 8 locations

A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer

Phase 2
Active, not recruiting
Conditions
HER2+ Breast Cancer
Breast Cancer
Interventions
Biological: Pembrolizumab
Biological: VRP-HER2
First Posted Date
2018-08-16
Last Posted Date
2024-12-11
Lead Sponsor
Herbert Lyerly
Target Recruit Count
8
Registration Number
NCT03632941
Locations
🇺🇸

Duke University, Durham, North Carolina, United States

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