MedPath

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)

Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer

Phase 1
Active, not recruiting
Conditions
Extensive Stage Small Cell Lung Carcinoma
Limited Stage Small Cell Lung Carcinoma
Neuroendocrine Neoplasm
Interventions
Other: Laboratory Biomarker Analysis
Procedure: Radiation Therapy
First Posted Date
2015-03-30
Last Posted Date
2025-05-15
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
83
Registration Number
NCT02402920
Locations
🇺🇸

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

Reversing Therapy Resistance With Epigenetic-Immune Modification

Phase 2
Terminated
Conditions
Breast Neoplasms
Interventions
First Posted Date
2015-03-23
Last Posted Date
2020-07-07
Lead Sponsor
University of California, San Francisco
Target Recruit Count
38
Registration Number
NCT02395627
Locations
🇺🇸

University of California, San Francisco Medical Center, San Francisco, California, United States

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Phase 1
Terminated
Conditions
UC
MPN
Lung Cancer
Solid Tumor
Gastric Cancer
Urothelial Cancer
Endometrial Cancer
Multiple Myeloma
Myeloproliferative Neoplasms
Breast Cancer
Interventions
First Posted Date
2015-03-19
Last Posted Date
2023-01-06
Lead Sponsor
Incyte Corporation
Target Recruit Count
201
Registration Number
NCT02393248
Locations
🇺🇸

Ohio State University - Wexner Medical Center, Columbus, Ohio, United States

🇺🇸

South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States

🇺🇸

University of Michigan Health System, Ann Arbor, Michigan, United States

and more 17 locations

Safety Study of SEA-CD40 in Cancer Patients

Phase 1
Terminated
Conditions
Neoplasms, Squamous Cell
Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer Metastatic
Melanoma
Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Neoplasm
Pancreatic Adenocarcinoma
Carcinoma, Squamous Cell
Lymphoma, Large B-Cell, Diffuse
Non-small Cell Carcinoma
Interventions
Drug: Intravenous (IV) SEA-CD40
Drug: Subcutaneous (SC) SEA-CD40
First Posted Date
2015-03-03
Last Posted Date
2023-05-01
Lead Sponsor
Seagen Inc.
Target Recruit Count
159
Registration Number
NCT02376699
Locations
🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

🇺🇸

MD Anderson Cancer Center / University of Texas, Houston, Texas, United States

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 16 locations

Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
Drug: mFOLFOX6
First Posted Date
2015-03-02
Last Posted Date
2022-02-16
Lead Sponsor
Hoosier Cancer Research Network
Target Recruit Count
30
Registration Number
NCT02375672
Locations
🇺🇸

Emory University: Winship Cancer Institute, Atlanta, Georgia, United States

🇺🇸

The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

Indiana University Simon Cancer Center, Indianapolis, Indiana, United States

Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects

Phase 1
Completed
Conditions
Urothelial Carcinoma
Bladder Cancer
Interventions
First Posted Date
2015-02-19
Last Posted Date
2025-03-18
Lead Sponsor
Jason R. Brown
Target Recruit Count
83
Registration Number
NCT02365766
Locations
🇺🇸

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

🇺🇸

Community Regional Cancer Care, Indianapolis, Indiana, United States

🇺🇸

IU Health Central Indiana Cancer Center, Indianapolis, Indiana, United States

and more 6 locations

Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib

Phase 1
Completed
Conditions
Recurrent Non-Small Cell Lung Carcinoma
Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Stage IIIA Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-02-18
Last Posted Date
2024-10-16
Lead Sponsor
Jonathan Riess
Target Recruit Count
11
Registration Number
NCT02364609
Locations
🇺🇸

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

Phase 2
Conditions
Thymic Carcinoma
Thymus Cancer
Thymus Neoplasms
Interventions
First Posted Date
2015-02-16
Last Posted Date
2019-12-13
Lead Sponsor
Georgetown University
Target Recruit Count
45
Registration Number
NCT02364076
Locations
🇺🇸

Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL

Phase 2
Completed
Conditions
Diffuse Large B Cell Lymphoma
Hodgkin Lymphoma
Peripheral T-Cell Lymphoma
Interventions
First Posted Date
2015-02-13
Last Posted Date
2023-07-27
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
82
Registration Number
NCT02362997
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 3 locations

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Phase 1
Active, not recruiting
Conditions
CLL
Small Lymphocytic Lymphoma (SLL)
Burkitt Lymphoma
Mediastinal Large B Cell Lymphoma
Richter's Syndrome
Waldenström Macroglobulinemia
Follicular Lymphoma (FL)
Indolent Non Hodgkin Lymphoma
Multiple Myeloma
Marginal Zone Lymphomas
Interventions
First Posted Date
2015-02-12
Last Posted Date
2025-03-12
Lead Sponsor
Acerta Pharma BV
Target Recruit Count
161
Registration Number
NCT02362035
Locations
🇺🇸

Research Site, Yakima, Washington, United States

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