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

Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform

Recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Diagnostic Test: Whole Genome Sequencing
Diagnostic Test: RNA-Sequencing
Diagnostic Test: Microbiome analysis
Diagnostic Test: ctDNA analysis
Diagnostic Test: TCR-β repertoire sequencing
Diagnostic Test: PBMCs phenotyping
Drug: Pembrolizumab
Drug: Chemotherapy

First Posted Date: 2023-06-23

Last Posted Date: 2023-06-23

Lead Sponsor: Vall d'Hebron Institute of Oncology

Target Recruit Count: 100

Registration Number: NCT05916755

Locations: 🇪🇸
Vall d'Hebron Institute of Oncology, Barcelona, Spain

GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Metastatic Melanoma
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: GB1211
Drug: Pembrolizumab
Drug: Placebo

First Posted Date: 2023-06-22

Last Posted Date: 2024-04-09

Lead Sponsor: Providence Health & Services

Target Recruit Count: 92

Registration Number: NCT05913388

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

Phase 3

Recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: gemcitabine
Drug: disitamab vedotin
Drug: pembrolizumab
Drug: cisplatin
Drug: carboplatin

First Posted Date: 2023-06-22

Last Posted Date: 2024-11-13

Lead Sponsor: Seagen Inc.

Target Recruit Count: 700

Registration Number: NCT05911295

Locations: 🇺🇸
Inova Schar Cancer Institute, Fairfax, Virginia, United States
🇧🇷
Hospital de Cancer de Barretos - Fundacao Pio XII, Barretos, Other, Brazil
🇧🇷
Centro de Oncologia da Bahia, Salvador, Other, Brazil

and more 113 locations

Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer

Phase 2

Not yet recruiting

Conditions: Colorectal Cancer

Interventions: Drug: Influenza vaccine
Drug: Pembrolizumab

First Posted Date: 2023-06-18

Last Posted Date: 2023-06-18

Lead Sponsor: Zealand University Hospital

Target Recruit Count: 21

Registration Number: NCT05909423

Locations: 🇩🇰
Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Zealand, Denmark

Pembrolizumab in Combination With Lenvatinib in Pts With Recurrent, Persistent, Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy

Phase 2

Not yet recruiting

Conditions: Recurrent Vulvar Cancer
Persistent Vulvar Cancer
Metastatic Vulva Cancer
Locally Advanced Vulvar Cancer

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2023-06-15

Last Posted Date: 2024-08-09

Lead Sponsor: AGO Research GmbH

Target Recruit Count: 42

Registration Number: NCT05903833

Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers

Phase 1

Withdrawn

Conditions: Urothelial Carcinoma

Interventions: Drug: Naptumomab Estafenatox
Drug: Pembrolizumab
Drug: Obinutuzumab

First Posted Date: 2023-06-08

Last Posted Date: 2024-04-12

Lead Sponsor: Weill Medical College of Cornell University

Registration Number: NCT05894447

Locations: 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States

Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Phase 1

Recruiting

Conditions: Carcinoma of Unknown Primary
Solid Tumors, Adult
Pancreatic Cancer
Cervical Cancer
Breast Cancer
Non Small Cell Lung Cancer
Endometrial Cancer

Interventions: Drug: TNG260
Drug: Pembrolizumab

First Posted Date: 2023-06-02

Last Posted Date: 2024-08-13

Lead Sponsor: Tango Therapeutics, Inc.

Target Recruit Count: 126

Registration Number: NCT05887492

Locations: 🇺🇸
NEXT Oncology Virginia, Fairfax, Virginia, United States
🇺🇸
UCLA Hematology/Oncology, Santa Monica, California, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States

and more 6 locations