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)

Safety and Efficacy Study of Pazopanib and MK 3475 in Advanced Renal Cell Carcinoma (RCC; KEYNOTE-018)

Phase 1
Completed
Conditions
Carcinoma, Renal Cell
Interventions
First Posted Date
2013-12-18
Last Posted Date
2020-03-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
42
Registration Number
NCT02014636
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab

Phase 1
Completed
Conditions
Esophageal Neoplasms
Adenocarcinoma of the Gastroesophageal Junction
Gastroesophageal Cancer
Squamous Cell Carcinoma
Gastric Adenocarcinoma
Interventions
Drug: DKN-01 150 mg
Drug: DKN-01 300 mg
First Posted Date
2013-12-17
Last Posted Date
2023-11-01
Lead Sponsor
Leap Therapeutics, Inc.
Target Recruit Count
151
Registration Number
NCT02013154
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

CTRC @ The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

and more 7 locations

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

Phase 1
Completed
Conditions
Prostate Cancer
Pancreatic Carcinoma
Solid Tumors
Breast Cancer
Melanoma
Renal Cell Carcinoma
Non-small Cell Lung Carcinoma
Ovarian Cancer
Colorectal Carcinoma
Interventions
Drug: Gemcitabine/carboplatin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Drug: gemcitabine/nab-paclitaxel
First Posted Date
2013-12-12
Last Posted Date
2024-11-15
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
353
Registration Number
NCT02009449
Locations
🇺🇸

UCLA Medical Hematology & Oncology, Los Angeles, California, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States

and more 7 locations

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

Phase 2
Completed
Conditions
Metastatic Melanoma
Interventions
First Posted Date
2013-11-25
Last Posted Date
2023-01-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
33
Registration Number
NCT01993719
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)

Phase 2
Completed
Conditions
MSI Positive Colorectal Cancer
MSI Negative Colorectal Cancer
MSI Positive Non-Colorectal Cancers
Interventions
First Posted Date
2013-06-12
Last Posted Date
2020-02-06
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
113
Registration Number
NCT01876511
Locations
🇺🇸

Providence Portland Medical Center, Portland, Oregon, United States

🇺🇸

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

🇺🇸

Stanford University, Stanford, California, United States

and more 4 locations

3rd Generation GD-2 Chimeric Antigen Receptor and ICaspase Suicide Safety Switch, Neuroblastoma, GRAIN

Phase 1
Active, not recruiting
Conditions
Neuroblastoma
Interventions
Genetic: iC9-GD2 T Cells - frozen
Genetic: iC9-GD2 T Cells - fresh
Genetic: iC9-GD2 T cells
First Posted Date
2013-04-02
Last Posted Date
2025-02-24
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
11
Registration Number
NCT01822652
Locations
🇺🇸

Texas Children's Hospital, Houston, Texas, United States

🇺🇸

Houston Methodist Hospital, Houston, Texas, United States

Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer

Phase 1
Completed
Conditions
Triple Negative Breast Cancer
Advanced or Metastatic Breast Cancer
Interventions
First Posted Date
2012-08-31
Last Posted Date
2022-09-21
Lead Sponsor
Jo Chien
Target Recruit Count
32
Registration Number
NCT01676753
Locations
🇺🇸

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

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

Phase 2
Recruiting
Conditions
Metastatic Colorectal Cancer
Metastatic Pancreatic Cancer
Metastatic Ovarian Cancer
Metastatic Breast Carcinoma
Metastatic Endocrine Tumors/ Neuroendocrine Tumors
Interventions
First Posted Date
2010-08-03
Last Posted Date
2025-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
332
Registration Number
NCT01174121
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Phase 2
Recruiting
Conditions
HER2-negative Breast Cancer
Hormone Receptor Positive Tumor
Angiosarcoma
TNBC - Triple-Negative Breast Cancer
Breast Neoplasms
Breast Tumors
HER2-positive Breast Cancer
Hormone Receptor Negative Tumor
Breast Cancer
Early-stage Breast Cancer
Interventions
First Posted Date
2010-01-05
Last Posted Date
2024-10-22
Lead Sponsor
QuantumLeap Healthcare Collaborative
Target Recruit Count
5000
Registration Number
NCT01042379
Locations
🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

University of Texas, Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

University of Kansas, Westwood, Kansas, United States

and more 33 locations
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