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

ATL001 in Patients with Advanced Unresectable or Metastatic NSCLC

Phase 1

Terminated

Conditions: Advanced Non Small Cell Lung Cancer

Interventions: Biological: ATL001
Drug: Pembrolizumab

First Posted Date: 2019-07-25

Last Posted Date: 2024-11-01

Lead Sponsor: Achilles Therapeutics UK Limited

Target Recruit Count: 27

Registration Number: NCT04032847

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 16 locations

LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Terminated

Conditions: Adenocarcinoma of Lung
Non-Small Cell Lung Cancer
Lung Cancer

Interventions: Drug: LMB-100
Drug: pembrolizumab
Diagnostic Test: Mesothelin Expression
Diagnostic Test: TrueSight Oncology 500

First Posted Date: 2019-07-22

Last Posted Date: 2024-04-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6

Registration Number: NCT04027946

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

Dual PD-1 and JAK2 Inhibition in Hematological Malignancies

Phase 2

Withdrawn

Conditions: Cancer
Hematological Malignancy

Interventions: Drug: Pembrolizumab
Drug: Ruxolitinib

First Posted Date: 2019-07-11

Last Posted Date: 2020-05-27

Lead Sponsor: NYU Langone Health

Registration Number: NCT04016116

Locations: 🇺🇸
New York University School of Medicine, New York, New York, United States

Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

Phase 2

Completed

Conditions: Recurrent Glioblastoma

Interventions: Drug: Pembrolizumab
Drug: SurVaxM
Drug: Sargramostim
Drug: Montanide ISA 51

First Posted Date: 2019-07-10

Last Posted Date: 2024-08-28

Lead Sponsor: David Peereboom

Target Recruit Count: 41

Registration Number: NCT04013672

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Biomarkers for Neoadjuvant Pembrolizumab in Non-Metastatic Prostate Cancer Positive by 18FDG-PET Scanning

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-07-08

Last Posted Date: 2024-07-01

Lead Sponsor: CHU de Quebec-Universite Laval

Target Recruit Count: 30

Registration Number: NCT04009967

Locations: 🇨🇦
CHU de Québec-Université Laval, Québec, Canada

Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

Phase 2

Terminated

Conditions: Unresectable Urothelial Carcinoma
Metastatic Urothelial Carcinoma

Interventions: Drug: Pemigatinib
Drug: Gemcitabine
Drug: Pembrolizumab
Drug: Carboplatin

First Posted Date: 2019-07-01

Last Posted Date: 2022-05-26

Lead Sponsor: Incyte Corporation

Target Recruit Count: 7

Registration Number: NCT04003610

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States
🇺🇸
The University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
Mount Sinai School of Medicine, New York, New York, United States

and more 76 locations

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

Phase 3

Active, not recruiting

Conditions: Biliary Tract Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Gemcitabine
Drug: Placebo
Drug: Cisplatin

First Posted Date: 2019-07-01

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1069

Registration Number: NCT04003636

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0014), Los Angeles, California, United States
🇺🇸
Hartford Hospital ( Site 0057), Hartford, Connecticut, United States
🇺🇸
Winship Cancer Institute of Emory University ( Site 0013), Atlanta, Georgia, United States

and more 182 locations

Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149

Phase 2

Terminated

Conditions: Adenocarcinoma
Gastroesophageal Cancer

Interventions: Drug: Pembrolizumab
Drug: Abemaciclib

First Posted Date: 2019-06-25

Last Posted Date: 2024-02-20

Lead Sponsor: Nataliya Uboha

Target Recruit Count: 3

Registration Number: NCT03997448

Locations: 🇺🇸
Rutgers Cancer Institute of NewJjersey, New Brunswick, New Jersey, United States
🇺🇸
Univerisy of Iowa Hospital and Clinics, Iowa City, Iowa, United States
🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

and more 1 locations

Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases

Phase 1

Terminated

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)
Drug: Pembrolizumab

First Posted Date: 2019-06-24

Last Posted Date: 2024-10-10

Lead Sponsor: Bayer

Target Recruit Count: 8

Registration Number: NCT03996473

Locations: 🇺🇸
Ccare San Marcos Cancer Center & Urology, San Marcos, California, United States
🇳🇱
Nederlands Kanker Instituut, Amsterdam, Netherlands
🇧🇪
UZ Gent, Gent, Belgium

and more 3 locations

Pembrolizumab in Combination With Chemotherapy for Patients With Untreated B Cell Lymphoma

Phase 2

Recruiting

Conditions: B Cell Lymphoma
Diffuse Large B Cell Lymphoma
Lymphoma
High-grade B-cell Lymphoma
Lymphoma, B-Cell

Interventions: Drug: Pembrolizumab
Drug: R-CHOP Protocol

First Posted Date: 2019-06-21

Last Posted Date: 2024-01-29

Lead Sponsor: University of Chicago

Target Recruit Count: 51

Registration Number: NCT03995147

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

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