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

Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer

Conditions: Advanced Colorectal Carcinoma

First Posted Date: 2021-02-25

Last Posted Date: 2021-02-25

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 100

Registration Number: NCT04771715

Locations: 🇨🇳
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma

Phase 2

Terminated

Conditions: Locally Advanced Unresectable or Metastatic Melanoma

Interventions: Drug: Selinexor
Drug: Pembrolizumab

First Posted Date: 2021-02-24

Last Posted Date: 2024-08-23

Lead Sponsor: Karyopharm Therapeutics Inc

Target Recruit Count: 15

Registration Number: NCT04768881

Locations: 🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Minnesota Oncology Hematology, Minneapolis, Minnesota, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 10 locations

FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer

Phase 2

Completed

Conditions: Gastric Cancer

Interventions: Drug: FLX475
Drug: Pembrolizumab

First Posted Date: 2021-02-24

Last Posted Date: 2023-12-26

Lead Sponsor: Hanmi Pharmaceutical Company Limited

Target Recruit Count: 20

Registration Number: NCT04768686

Locations: 🇰🇷
The Catholic University of Korea St. Vincent Hospital, Suwon-si,, Gyeonggi-do, Korea, Republic of
🇰🇷
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
🇰🇷
Hanllym University Medical Center, Anyang-si, Gyeonggi-do, Korea, Republic of

and more 7 locations

Study of Pembrolizumab With Single Agent Chemotherapy in Elderly Patients With Advanced NSCLC

Phase 2

Withdrawn

Conditions: Non Small Cell Lung Cancer
Advanced Lung Non-Small Cell Carcinoma
PD-L1 Gene Mutation

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Paclitaxel
Other: Laboratory Biomarker Analysis
Drug: Nab-paclitaxel

First Posted Date: 2021-02-15

Last Posted Date: 2022-03-29

Lead Sponsor: Shirish Gadgeel

Registration Number: NCT04754815

Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.

Phase 2

Recruiting

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Cisplatin
Drug: Irinotecan
Drug: Capecitabine
Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2021-02-15

Last Posted Date: 2024-08-23

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 38

Registration Number: NCT04753879

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

Phase 2

Conditions: Nonsquamous Non-small Cell Lung Cancer

Interventions: Drug: HX008
Drug: Pembrolizumab
Drug: pemetrexed
Drug: cisplatin/carboplatin

First Posted Date: 2021-02-11

Last Posted Date: 2021-02-11

Lead Sponsor: Taizhou Hanzhong biomedical co. LTD

Target Recruit Count: 700

Registration Number: NCT04750083

Locations: 🇨🇳
Xiangya Hospital Central South University, Changsha, Hunan, China
🇨🇳
Liaoning Cancer Hospital & Insititute, Shenyang, Liaoning, China
🇨🇳
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China

and more 7 locations

A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

Phase 3

Active, not recruiting

Conditions: Non-small Cell Lung Cancer
NSCLC

Interventions: Drug: Tislelizumab
Drug: Pembrolizumab
Drug: Ociperlimab
Drug: Placebo

First Posted Date: 2021-02-10

Last Posted Date: 2024-10-26

Lead Sponsor: BeiGene

Target Recruit Count: 662

Registration Number: NCT04746924

Locations: 🇺🇸
Virginia Cancer Specialists, Fairfax, Virginia, United States
🇺🇸
Providence Medical Foundation St Jude Heritage Healthcare, Fullerton, California, United States
🇺🇸
Valkyrie Clinical Trials, Los Angeles, California, United States

and more 32 locations

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers

Phase 3

Recruiting

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Pembrolizumab
Radiation: Loco-regional radiotherapy
Drug: Chemotherapy

First Posted Date: 2021-02-10

Last Posted Date: 2024-10-26

Lead Sponsor: UNICANCER

Target Recruit Count: 102

Registration Number: NCT04747054

Locations: 🇫🇷
Institut Jean Godinot, Reims, France
🇫🇷
Centre Henri Becquerel, Rouen, France
🇫🇷
Institut de Cancérologie Strasbourg-Europe, Strasbourg, France

and more 23 locations

An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib with Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients with Gastric Cancer

Phase 2

Active, not recruiting

Conditions: Gastric Cancer

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib 20mg
Drug: Lenvatinib 8mg
Drug: Docetaxel
Drug: Oxaliplatin
Drug: Levofolinate
Drug: Fluorouracil

First Posted Date: 2021-02-09

Last Posted Date: 2024-11-15

Lead Sponsor: National Cancer Center Hospital East

Target Recruit Count: 43

Registration Number: NCT04745988

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

Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)

Phase 2

Active, not recruiting

Conditions: Advanced Hepatocellular Carcinoma

Interventions: Biological: Pembrolizumab/Quavonlimab
Drug: Lenvatinib
Biological: Pembrolizumab

First Posted Date: 2021-02-05

Last Posted Date: 2023-11-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 110

Registration Number: NCT04740307

Locations: 🇺🇸
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013), Baltimore, Maryland, United States
🇨🇭
CHUV (centre hospitalier universitaire vaudois) ( Site 0333), Lausanne, Vaud, Switzerland
🇪🇸
Hospital Universitario Central de Asturias-Hepatology ( Site 0309), Oviedo, Asturias, Spain

and more 37 locations

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