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

Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer

Phase 3

Active, not recruiting

Conditions: Locally Advanced Ureter Urothelial Carcinoma
Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
Stage II Ureter Cancer AJCC v7
Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
Localized Renal Pelvis and Ureter Urothelial Carcinoma
Locally Advanced Bladder Urothelial Carcinoma
Stage III Ureter Cancer AJCC v7
Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma
Stage II Renal Pelvis and Ureter Cancer AJCC v7
Stage III Renal Pelvis and Ureter Cancer AJCC v7

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Other: Clinical Observation
Procedure: CT Urography
Procedure: Cystoscopy
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2017-08-09

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 739

Registration Number: NCT03244384

Locations: 🇺🇸
Saint Anthony Regional Hospital, Carroll, Iowa, United States
🇺🇸
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
🇺🇸
Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States

and more 917 locations

Pembrolizumab in Combination With Platinum-Based Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Targetable Genetic Alterations, Previously Treated With Appropriate Targeted Agents, With Progressive Disease

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2017-08-08

Last Posted Date: 2024-02-28

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 33

Registration Number: NCT03242915

Locations: 🇺🇸
The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Henry Ford Cancer Institute/Henry Ford Hospital, Detroit, Michigan, United States
🇺🇸
Sarah Cannon, Nashville, Tennessee, United States

and more 4 locations

Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL

Phase 1

Recruiting

Conditions: CTCL
PTCL

Interventions: Drug: Pembrolizumab
Drug: Pralatrexate
Drug: Decitabine

First Posted Date: 2017-08-07

Last Posted Date: 2024-05-20

Lead Sponsor: University of Virginia

Target Recruit Count: 37

Registration Number: NCT03240211

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States
🇺🇸
Allegheny Health Network, Pittsburgh, Pennsylvania, United States

PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-08-04

Last Posted Date: 2024-02-13

Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Target Recruit Count: 13

Registration Number: NCT03239899

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

Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer

Phase 2

Completed

Conditions: Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Abraxane

First Posted Date: 2017-08-04

Last Posted Date: 2023-08-31

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 36

Registration Number: NCT03240016

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Phase 2

Withdrawn

Conditions: Head and Neck Cancer

Interventions: Drug: Pembrolizumab
Drug: epacadostat

First Posted Date: 2017-08-03

Last Posted Date: 2018-01-04

Lead Sponsor: University of Chicago

Registration Number: NCT03238638

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: Pembrolizumab
Drug: Trebananib

First Posted Date: 2017-08-03

Last Posted Date: 2024-03-20

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 60

Registration Number: NCT03239145

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Phase Ib of L-NMMA and Pembrolizumab

Phase 1

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer
DNA Repair-Deficiency Disorders
Urothelial Carcinoma Bladder
Malignant Melanoma
Classical Hodgkin Lymphoma
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: L-NMMA
Drug: Pembrolizumab

First Posted Date: 2017-08-02

Last Posted Date: 2024-08-12

Lead Sponsor: The Methodist Hospital Research Institute

Target Recruit Count: 12

Registration Number: NCT03236935

Locations: 🇺🇸
Houston Methodist Cancer Center, Houston, Texas, United States

Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer

Phase 1

Terminated

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Device: High-intensity focused ultrasound (HIFU)

First Posted Date: 2017-08-02

Last Posted Date: 2022-09-13

Lead Sponsor: Patrick Dillon, MD

Target Recruit Count: 13

Registration Number: NCT03237572

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States

Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas

Phase 1

Terminated

Conditions: Lung Cancer
Carcinoma, Non-Small-Cell Lung
Carcinoma, Esophageal
Non-Small Cell Lung Cancer
Malignant Pleural Mesotheliomas

Interventions: Drug: Decitabine (DAC)
Drug: Tetrahydrouridine (THU)
Drug: Pembrolizumab

First Posted Date: 2017-07-31

Last Posted Date: 2023-05-31

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT03233724

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

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