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

A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

Phase 2

Active, not recruiting

Conditions: Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Placebo
Drug: Pembrolizumab

First Posted Date: 2016-07-22

Last Posted Date: 2024-05-13

Lead Sponsor: University of Chicago

Target Recruit Count: 100

Registration Number: NCT02841748

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 1 locations

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

Phase 2

Terminated

Conditions: Penile Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-07-19

Last Posted Date: 2022-06-21

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 6

Registration Number: NCT02837042

Locations: 🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Winship Cancer Institute at Emory University, Atlanta, Georgia, United States

PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Adenocarcinoma
Stage IVA Colorectal Cancer
Colorectal Cancer
Metastatic Carcinoma in the Liver
Stage IVB Colorectal Cancer

Interventions: Radiation: Stereotactic body radiotherapy (SBRT)
Drug: Pembrolizumab

First Posted Date: 2016-07-19

Last Posted Date: 2023-06-12

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 18

Registration Number: NCT02837263

Locations: 🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC).

Phase 2

Terminated

Conditions: Fallopian Tube Cancer
Peritoneum Cancer
Epithelial Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin

First Posted Date: 2016-07-15

Last Posted Date: 2023-11-07

Lead Sponsor: University of Miami

Target Recruit Count: 26

Registration Number: NCT02834975

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Pembrolizumab + Poly-ICLC in MRP Colon Cancer

Phase 1

Completed

Conditions: Metastatic Colon Cancer
Solid Tumor

Interventions: Drug: pembrolizumab
Drug: Poly-ICLC

First Posted Date: 2016-07-15

Last Posted Date: 2024-06-07

Lead Sponsor: Asha Nayak

Target Recruit Count: 42

Registration Number: NCT02834052

Locations: 🇺🇸
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States

Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer

Phase 1

Completed

Conditions: Metastatic Urothelial Cancer

Interventions: Drug: pembrolizumab

First Posted Date: 2016-07-11

Last Posted Date: 2024-07-17

Lead Sponsor: University Hospital, Ghent

Target Recruit Count: 18

Registration Number: NCT02826564

Locations: 🇧🇪
University Hospital Ghent, Ghent, Belgium

Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients

Phase 2

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: BL-8040
Drug: Pembrolizumab
Drug: Chemotherapy

First Posted Date: 2016-07-11

Last Posted Date: 2024-08-28

Lead Sponsor: BioLineRx, Ltd.

Target Recruit Count: 80

Registration Number: NCT02826486

Locations: 🇺🇸
Beth Israel Deaconess Medical Center (BIDMAC), Boston, Massachusetts, United States
🇺🇸
University of Rochester, Rochester, New York, United States
🇮🇱
Sourasky Medical Center, Tel Aviv, Israel

and more 28 locations

Pembrolizumab + CVA21 in Advanced NSCLC

Phase 1

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Biological: CVA21

First Posted Date: 2016-07-07

Last Posted Date: 2021-07-07

Lead Sponsor: Olivia Newton-John Cancer Research Institute

Target Recruit Count: 11

Registration Number: NCT02824965

Locations: 🇦🇺
Austin Health, Heidelberg, Victoria, Australia

X4P-001 and Pembrolizumab in Patients With Advanced Melanoma

Phase 1

Completed

Conditions: Melanoma

Interventions: Drug: X4P-001
Drug: Pembrolizumab

First Posted Date: 2016-07-06

Last Posted Date: 2020-07-07

Lead Sponsor: X4 Pharmaceuticals

Target Recruit Count: 16

Registration Number: NCT02823405

Locations: 🇺🇸
Clinical Site, Salt Lake City, Utah, United States

Neoadjuvant Pembrolizumab

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-06-30

Last Posted Date: 2024-06-18

Lead Sponsor: Neal Ready MD PhD

Target Recruit Count: 35

Registration Number: NCT02818920

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

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