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 ...

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

Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

Phase 1

Active, not recruiting

Conditions: Malignant Pleural Disease
Lung Cancer
Metastases
Mesothelioma
Breast Cancer

Interventions: Genetic: iCasp9M28z T cell infusions
Drug: pembrolizumab
Drug: cyclophosphamide

First Posted Date: 2015-04-10

Last Posted Date: 2024-05-17

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 113

Registration Number: NCT02414269

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Consent and Follow-Up), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Consent and Follow-Up), Montvale, New Jersey, United States

and more 3 locations

Study of Pembrolizumab With Chemotherapy in Patients With Advanced Lymphoma (PembroHeme)

Phase 1

Withdrawn

Conditions: Lymphoma
Hodgkin's Lymphoma
Non-hodgkin's Lymphoma

Interventions: Drug: Pembrolizumab
Drug: Brentuximab vedotin
Drug: Etoposide
Drug: Ifosfamide
Drug: Mesna
Drug: Carboplatin
Drug: Rituximab

First Posted Date: 2015-04-03

Last Posted Date: 2017-06-27

Lead Sponsor: Western Regional Medical Center

Registration Number: NCT02408042

Locations: 🇺🇸
Cancer Treatment Center of America @ Western Regional Medical Center, Goodyear, Arizona, United States

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: Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Procedure: Radiation Therapy

First Posted Date: 2015-03-30

Last Posted Date: 2024-11-29

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: Drug: Tamoxifen
Drug: Vorinostat
Drug: Pembrolizumab

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: Drug: Pemigatinib
Drug: Docetaxel
Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Trastuzumab
Drug: Retifanlimab
Drug: Cisplatin

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
Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Nab-paclitaxel

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: Pembrolizumab
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

Active, not recruiting

Conditions: Urothelial Carcinoma
Bladder Cancer

Interventions: Drug: Pembrolizumab
Drug: Gemcitabine
Procedure: Consolidative Surgery
Drug: Cisplatin

First Posted Date: 2015-02-19

Last Posted Date: 2024-02-20

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