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

Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)

Early Phase 1

Recruiting

Conditions: Carcinoma, Intraductal, Noninfiltrating

Interventions: Drug: Pembrolizumab
Biological: Intralesional mRNA 2752

First Posted Date: 2016-08-18

Last Posted Date: 2024-06-11

Lead Sponsor: Laura Esserman

Target Recruit Count: 68

Registration Number: NCT02872025

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)

Phase 3

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Pembrolizumab
Drug: Docetaxel

First Posted Date: 2016-08-12

Last Posted Date: 2024-07-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 425

Registration Number: NCT02864394

Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer

Phase 2

Completed

Conditions: Peritoneal Cancer
Ovarian Cancer
Fallopian Tube Cancer

Interventions: Drug: Pembrolizumab
Drug: Pegylated Liposomal Doxorubicin (PLD)

First Posted Date: 2016-08-12

Last Posted Date: 2022-09-13

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 26

Registration Number: NCT02865811

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Northwell Hospital Monter Cancer Center, Lake Success, New York, United States

Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib
Drug: Pembrolizumab

First Posted Date: 2016-08-08

Last Posted Date: 2023-08-30

Lead Sponsor: Melanoma Institute Australia

Target Recruit Count: 60

Registration Number: NCT02858921

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
🇦🇺
Westmead Hospital, Sydney, New South Wales, Australia
🇦🇺
Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia

Stereotactic Radiotherapy and Anti-PD1 Antibody (Pembrolizumab) for Oligometastatic Renal Tumours

Phase 1

Completed

Conditions: Renal Cell Carcinoma

Interventions: Radiation: Stereotactic Ablative Body Radiosurgery (SABR)
Drug: Pembrolizumab

First Posted Date: 2016-08-04

Last Posted Date: 2023-08-03

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 30

Registration Number: NCT02855203

Locations: 🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Trial Of Pembrolizumab And Nintedanib

Phase 1

Recruiting

Conditions: Patients With Any Advanced Solid Tumors

Interventions: Drug: Nintedanib
Drug: Pembrolizumab

First Posted Date: 2016-08-04

Last Posted Date: 2023-04-25

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 221

Registration Number: NCT02856425

Locations: 🇫🇷
Hôpital Bichat, Paris, France
🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
IUCT--O, Toulouse, France

and more 2 locations

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)

Phase 3

Active, not recruiting

Conditions: Renal Cell Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Sunitinib
Drug: Axitinib

First Posted Date: 2016-08-02

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 861

Registration Number: NCT02853331

Special Combination of BBI608 and Pembrolizumab

Phase 1

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Napabucasin
Drug: Pembrolizumab

First Posted Date: 2016-08-01

Last Posted Date: 2021-09-05

Lead Sponsor: Takayuki Yoshino

Target Recruit Count: 55

Registration Number: NCT02851004

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: pembrolizumab
Drug: Azacitadine

First Posted Date: 2016-07-27

Last Posted Date: 2023-03-09

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 67

Registration Number: NCT02845297

Locations: 🇺🇸
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
🇺🇸
University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina, United States

Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors

Phase 1

Completed

Conditions: Malignant Solid Tumour

Interventions: Drug: Pembrolizumab
Biological: NK immunotherapy

First Posted Date: 2016-07-25

Last Posted Date: 2020-05-28

Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Target Recruit Count: 110

Registration Number: NCT02843204

Locations: 🇨🇳
Cancer Institute in Fuda Cancer Hospital, Guangzhou, Guangdong, China

Drug Development Updates

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