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

Pembrolizumab (immunotherapy Drug) in Combination with Guadecitabine and Mocetinostat (epigenetic Drugs) for Patients with Advanced Lung Cancer.

Phase 1

Active, not recruiting

Conditions: Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Guadecitabine
Drug: Mocetinostat

First Posted Date: 2017-07-18

Last Posted Date: 2024-12-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT03220477

Locations: 🇺🇸
John Hopkins Medical Center, Baltimore, Maryland, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

Phase 3

Active, not recruiting

Conditions: Gastric Cancer
Gastroesophageal Junction Cancer

Interventions: Drug: Placebo
Biological: Pembrolizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Capecitabine
Drug: Oxaliplatin
Drug: 5-fluorouracil
Drug: Leucovorin

First Posted Date: 2017-07-18

Last Posted Date: 2024-10-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1007

Registration Number: NCT03221426

Locations: 🇺🇸
Fox Chase Cancer Center ( Site 0006), Philadelphia, Pennsylvania, United States
🇨🇦
Cross Cancer Institute ( Site 0033), Edmonton, Alberta, Canada
🇨🇦
Jewish General Hospital ( Site 0034), Montreal, Quebec, Canada

and more 168 locations

A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.

Phase 1

Recruiting

Conditions: Lymphocytic Leukemia

Interventions: Drug: NeoVax
Drug: Cyclophosphamide
Drug: Pembrolizumab

First Posted Date: 2017-07-17

Last Posted Date: 2024-04-23

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 15

Registration Number: NCT03219450

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Procedure: Surgery (Non-interventional, standard of care)
Radiation: stereotactic radiation therapy (SRT)

First Posted Date: 2017-07-13

Last Posted Date: 2024-10-23

Lead Sponsor: Sue Yom

Target Recruit Count: 12

Registration Number: NCT03217071

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Study Evaluating Neoadjuvant Pembrolizumab Monotherapy in Patients With Muscle-Invasive Bladder Cancer to Explore in Vivo the Mechanisms of Action of Pembrolizumab

Phase 2

Completed

Conditions: Bladder Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-07-11

Last Posted Date: 2023-01-20

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 41

Registration Number: NCT03212651

Locations: 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France

Pembrolizumab and External Beam Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Recurrent Aggressive Non-Hodgkin Lymphoma
Recurrent T-Cell Non-Hodgkin Lymphoma
Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Recurrent Non-Hodgkin Lymphoma
Refractory Aggressive Non-Hodgkin Lymphoma
Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Refractory T-Cell Non-Hodgkin Lymphoma
Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions: Radiation: External Beam Radiation Therapy
Biological: Pembrolizumab

First Posted Date: 2017-07-07

Last Posted Date: 2024-11-14

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT03210662

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 2

Active, not recruiting

Conditions: Leukemia, Chronic Lymphatic
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphocytic Leukemia, Chronic, B Cell
Lymphocytic Leukemia, Chronic, B-Cell
B-Cell Chronic Lymphocytic Leukemia
B-Lymphocytic Leukemia, Chronic
Chronic Lymphocytic Leukemia
Leukemia, Chronic Lymphocytic, B-Cell
Leukemia, Lymphocytic, Chronic

Interventions: Drug: Ibrutinib
Drug: Fludarabine
Drug: Pembrolizumab

First Posted Date: 2017-06-29

Last Posted Date: 2023-11-28

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 15

Registration Number: NCT03204188

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Pembrolizumab and Standard Therapy in Treating Patients with Glioblastoma

Phase 2

Active, not recruiting

Conditions: Glioblastoma
Gliosarcoma
Supratentorial Glioblastoma

Interventions: Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Radiation: Radiation Therapy
Drug: Temozolomide
Procedure: Therapeutic Conventional Surgery

First Posted Date: 2017-06-23

Last Posted Date: 2024-10-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 52

Registration Number: NCT03197506

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States