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

Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

Phase 2

Active, not recruiting

Conditions: Head and Neck Cancer
Cancer of Head and Neck
Cancer of Neck
Head and Neck Squamous Cell Carcinoma
Head and Neck Carcinoma
Head and Neck Cancer Stage III
Head and Neck Cancer Stage IV
Cancer
Head and Neck Cancer Metastatic
Cancer, Metastatic

Interventions: Drug: Pembrolizumab
Drug: Tadalafil

First Posted Date: 2019-06-20

Last Posted Date: 2024-11-18

Lead Sponsor: University of California, San Diego

Target Recruit Count: 7

Registration Number: NCT03993353

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States

Pembrolizumab for Patients With PD-L1 Diffuse Large B Cell Lymphoma (DLBCL)

Phase 2

Active, not recruiting

Conditions: Diffuse Large B Cell Lymphoma
Lymphoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-06-19

Last Posted Date: 2024-07-11

Lead Sponsor: University of Chicago

Target Recruit Count: 5

Registration Number: NCT03990961

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

Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Non-small Cell Carcinoma

Interventions: Drug: Binimetinib
Drug: Pembrolizumab

First Posted Date: 2019-06-19

Last Posted Date: 2024-07-16

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 40

Registration Number: NCT03991819

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada

Study of Pembrolizumab in Metastatic HER2-negative Breast Cancer Patients With APOBEC3B Mutation

Phase 2

Active, not recruiting

Conditions: HER2-Negative Breast Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-06-18

Last Posted Date: 2024-12-18

Lead Sponsor: University of Malaya

Target Recruit Count: 44

Registration Number: NCT03989089

Locations: 🇲🇾
University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia
🇸🇬
National University Hospital, Singapore, Singapore

A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Trastuzumab Biosimilar ABP 980
Drug: Pertuzumab

First Posted Date: 2019-06-17

Last Posted Date: 2023-05-15

Lead Sponsor: West German Study Group

Target Recruit Count: 46

Registration Number: NCT03988036

Locations: 🇩🇪
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg Zentrum für Frauenheilkunde und Abteilung für Senologie, Georgsmarienhütte, Lower Saxony, Germany
🇩🇪
Mammazentrum Hamburg, Hamburg, Germany
🇩🇪
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Bavaria, Germany

and more 9 locations

Palliative RT & Anti-PD-1/PD-L1 Checkpoint Blockade in Metastatic Merkel Cell Carcinoma

Phase 2

Terminated

Conditions: Merkel Cell Carcinoma

Interventions: Drug: Pembrolizumab
Radiation: Radiation Therapy

First Posted Date: 2019-06-17

Last Posted Date: 2021-08-09

Lead Sponsor: Stanford University

Target Recruit Count: 1

Registration Number: NCT03988647

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Window of Opportunity Study in Colorectal Cancer

Phase 2

Recruiting

Conditions: Colorectal Cancer

Interventions: Drug: Capecitabine/ 5-FU
Drug: CAPEOX
Drug: CAPEOX/Pembrolizumab
Drug: Pembrolizumab alone
Drug: Pembrolizumab
Procedure: Surgical resection

First Posted Date: 2019-06-13

Last Posted Date: 2024-10-14

Lead Sponsor: National Cancer Centre, Singapore

Target Recruit Count: 50

Registration Number: NCT03984578

Locations: 🇸🇬
National Cancer Centre Singapore, Singapore, Singapore
🇸🇬
Singapore General Hospital, Singapore, Singapore
🇸🇬
Sengkang General Hospital, Singapore, Singapore

CMP-001 for Relapsed and Refractory Lymphoma

Phase 1

Active, not recruiting

Conditions: Lymphoma

Interventions: Drug: CMP-001
Drug: Pembrolizumab

First Posted Date: 2019-06-12

Last Posted Date: 2024-11-21

Lead Sponsor: Umar Farooq

Target Recruit Count: 39

Registration Number: NCT03983668

Locations: 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

Phase 1

Terminated

Conditions: Metastatic Breast Cancer

Interventions: Device: Epicutaneous cryoimmunotherapy
Drug: Topical imiquimod
Drug: Pembrolizumab
Other: Dermatologic Quality of Life Index
Other: Functional Assessment of Cancer Therapy
Drug: Intra-lesional GM-CSF
Device: Cry-AC
Procedure: Cutaneous tumor biopsy
Procedure: Peripheral blood draw for research

First Posted Date: 2019-06-11

Last Posted Date: 2021-06-21

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 1

Registration Number: NCT03982004

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer

Phase 2

Active, not recruiting

Conditions: Bladder Cancer

Interventions: Drug: Pembrolizumab
Drug: Entinostat

First Posted Date: 2019-06-07

Last Posted Date: 2024-02-05

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 20

Registration Number: NCT03978624

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

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