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

Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers

Phase 1

Active, not recruiting

Conditions: Advanced Cancer

Interventions: Drug: personalized vaccine
Drug: Pembrolizumab

First Posted Date: 2018-06-26

Last Posted Date: 2024-11-13

Lead Sponsor: Ezra Cohen

Target Recruit Count: 30

Registration Number: NCT03568058

Locations: 🇺🇸
UCSD Medical Center, San Diego, California, United States

Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)

Phase 1

Active, not recruiting

Conditions: Neoplasms

Interventions: Biological: MK-4830A
Drug: MK-4830
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Lenvatinib
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin

First Posted Date: 2018-06-21

Last Posted Date: 2024-11-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 442

Registration Number: NCT03564691

Locations: 🇨🇦
Princess Margaret Cancer Centre ( Site 0033), Toronto, Ontario, Canada
🇺🇸
Seattle Cancer Care Alliance ( Site 0010), Seattle, Washington, United States
🇺🇸
University of California at San Francisco ( Site 0004), San Francisco, California, United States

and more 34 locations

A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumors

Interventions: Drug: ASP1948
Drug: nivolumab
Drug: pembrolizumab

First Posted Date: 2018-06-21

Last Posted Date: 2024-11-01

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 190

Registration Number: NCT03565445

Locations: 🇺🇸
UPMC- Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Virginia Cancer Care Specialist, PC, Fairfax, Virginia, United States
🇺🇸
Mary Crowley Cancer Research Center, Dallas, Texas, United States

and more 39 locations

Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: Stage IV Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Carboplatin
Drug: Rucaparib

First Posted Date: 2018-06-15

Last Posted Date: 2024-10-02

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 25

Registration Number: NCT03559049

Locations: 🇺🇸
The University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

Phase 3

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Other: Placebo

First Posted Date: 2018-06-12

Last Posted Date: 2024-11-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 976

Registration Number: NCT03553836

Locations: 🇺🇸
The Angeles Clinic and Research Institute ( Site 0029), Los Angeles, California, United States
🇺🇸
Winship Cancer Institute of Emory University ( Site 0046), Atlanta, Georgia, United States
🇺🇸
UCLA Hematology & Oncology ( Site 0130), Los Angeles, California, United States

and more 156 locations

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

Phase 2

Recruiting

Conditions: Metastatic Urothelial Cancer

Interventions: Drug: Sacituzumab Govitecan-hziy
Drug: Zimberelimab
Drug: Cisplatin
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Domvanalimab
Drug: Avelumab
Drug: Gemcitabine
Drug: Enfortumab Vedotin

First Posted Date: 2018-06-06

Last Posted Date: 2024-12-11

Lead Sponsor: Gilead Sciences

Target Recruit Count: 643

Registration Number: NCT03547973

Locations: 🇺🇸
The University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 132 locations

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions: Drug: Pembrolizumab
Radiation: Stereotactic Body Radiation Therapy (SBRT)

First Posted Date: 2018-06-06

Last Posted Date: 2023-06-02

Lead Sponsor: RTOG Foundation, Inc.

Target Recruit Count: 102

Registration Number: NCT03546582

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
🇺🇸
University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States
🇺🇸
Ohio State University, Columbus, Ohio, United States

and more 18 locations

Pembrolizumab Plus Autologous Dendritic Cell Vaccine in Patients With PD-L1 Negative Advanced Mesothelioma Who Have Failed Prior Therapies

Phase 1

Active, not recruiting

Conditions: Mesothelioma, Malignant
PD-L1 Negative
Advanced Cancer
Progressive Disease

Interventions: Drug: Pembrolizumab
Biological: Autologous dendritic cells
Drug: Interleukin-2

First Posted Date: 2018-06-06

Last Posted Date: 2024-10-01

Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Target Recruit Count: 18

Registration Number: NCT03546426

Locations: 🇮🇹
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, FC, Italy

Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Procedure: Core Biopsy/Cryoablation
Procedure: Breast Surgery
Drug: Ipilimumab
Drug: Nivolumab

First Posted Date: 2018-06-06

Last Posted Date: 2024-07-24

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 80

Registration Number: NCT03546686

Locations: 🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States
🇺🇸
Providence Cancer Institute, Portland, Oregon, United States

and more 1 locations

Pembrolizumab for Nasopharyngeal Carcinoma Patients With Detectable Plasma Epstein-Barr Virus DNA

Phase 2

Terminated

Conditions: Nasopharyngeal Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-06-01

Last Posted Date: 2023-04-11

Lead Sponsor: National Health Research Institutes, Taiwan

Target Recruit Count: 2

Registration Number: NCT03544099

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇨🇳
Changhua Christian Hospital, Changhua, Taiwan
🇨🇳
Chang Gung Memorial Hospital, Linkou, Taiwan

and more 5 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy