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

Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma

Phase 2

Recruiting

Conditions: Locally Advanced Bladder Urothelial Carcinoma
Locally Advanced Renal Pelvis Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Locally Advanced Urethral Urothelial Carcinoma
Locally Advanced Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Propranolol Hydrochloride
Drug: Nivolumab
Drug: Avelumab

First Posted Date: 2021-04-19

Last Posted Date: 2024-06-10

Lead Sponsor: Emory University

Target Recruit Count: 24

Registration Number: NCT04848519

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer
Breast Cancer

Interventions: Drug: Capecitabine
Drug: Talazoparib
Drug: Pembrolizumab
Drug: Inavolisib

First Posted Date: 2021-04-19

Last Posted Date: 2023-11-13

Lead Sponsor: Bryan Schneider, MD

Target Recruit Count: 197

Registration Number: NCT04849364

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Georgetown University, Washington, District of Columbia, United States
🇺🇸
Memorial Healthcare System, Hollywood, Florida, United States

and more 10 locations

Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer

Phase 2

Recruiting

Conditions: Gastroesophageal Junction (GEJ) Cancers
Advanced HNSCC

Interventions: Drug: N-803
Drug: Pembrolizumab
Biological: PD-L1 t-haNK

First Posted Date: 2021-04-19

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT04847466

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

Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: Tumor, Solid

Interventions: Drug: BDB018
Drug: Pembrolizumab

First Posted Date: 2021-04-12

Last Posted Date: 2024-02-01

Lead Sponsor: Eikon Therapeutics

Target Recruit Count: 1

Registration Number: NCT04840394

Locations: 🇺🇸
START MidWest, Grand Rapids, Michigan, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
START, San Antonio, Texas, United States

A Trial of Tigilanol Tiglate in Combination With Pembrolizumab in Stage IIIB to IV M1c-melanoma

Phase 1

Terminated

Conditions: Melanoma

Interventions: Drug: tigilanol tiglate
Drug: pembrolizumab

First Posted Date: 2021-04-08

Last Posted Date: 2023-04-18

Lead Sponsor: QBiotics Group Limited

Target Recruit Count: 3

Registration Number: NCT04834973

Locations: 🇦🇺
Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia
🇦🇺
Cairns and Hinterland Hospital and Health Service, Cairns, Queensland, Australia

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen

Phase 1

Completed

Conditions: Advanced Malignancies
Advanced Cancer

Interventions: Drug: ASP7517
Drug: Pembrolizumab

First Posted Date: 2021-04-08

Last Posted Date: 2024-11-13

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 24

Registration Number: NCT04837196

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
University of Iowa Hospitals, Iowa City, Iowa, United States

and more 1 locations

Electroporation Potentiated Immunotherapy in Cancer

Phase 2

Active, not recruiting

Conditions: Pancreas Cancer, Metastatic

Interventions: Drug: Pembrolizumab
Device: Irreversible electroporation

First Posted Date: 2021-04-08

Last Posted Date: 2022-03-09

Lead Sponsor: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

Target Recruit Count: 8

Registration Number: NCT04835402

Locations: 🇩🇰
Department of Oncology, Aalborg, North Denmark Region, Denmark

Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma - ARTISTRY-6

Phase 2

Recruiting

Conditions: Cutaneous Melanoma
Mucosal Melanoma

Interventions: Drug: Nemvaleukin Alfa Subcutaneous
Drug: Nemvaleukin Alfa Intravenous
Drug: Nemvaleukin Alfa Intravenous Less Frequent Dosing
Drug: Pembrolizumab

First Posted Date: 2021-04-02

Last Posted Date: 2024-07-01

Lead Sponsor: Mural Oncology, Inc

Target Recruit Count: 180

Registration Number: NCT04830124

Locations: 🇨🇳
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
🇺🇸
UT Southwestern Medical Center of Dallas, Dallas, Texas, United States
🇪🇸
Hospital Clinic Barcelona, Barcelona, Spain

and more 40 locations

Futibatinib and Pembrolizumab for Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

Phase 2

Active, not recruiting

Conditions: Advanced Hepatocellular Carcinoma
BCLC Stage A Hepatocellular Carcinoma
BCLC Stage B Hepatocellular Carcinoma
BCLC Stage C Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma