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

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

Phase 3

Recruiting

Conditions: Metastatic Non-small Cell Lung Cancer

Interventions: Drug: Volrustomig
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed

First Posted Date: 2023-08-09

Last Posted Date: 2024-12-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 900

Registration Number: NCT05984277

Locations: 🇬🇧
Research Site, Truro, United Kingdom

TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Head and Neck Neoplasms

Interventions: Drug: TransCon TLR7/8 Agonist
Drug: Pembrolizumab
Drug: TransCon IL-2 β/γ

First Posted Date: 2023-08-08

Last Posted Date: 2024-12-04

Lead Sponsor: Ascendis Pharma Oncology Division A/S

Target Recruit Count: 27

Registration Number: NCT05980598

Locations: 🇨🇳
Ascendis Investigational Site, Taoyuan, Taiwan
🇺🇸
Ascendis Pharma Investigational Site, Canton, Ohio, United States
🇪🇸
Ascendis Investigational Site II, Madrid, Spain

A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: STI-7349
Drug: Pembrolizumab
Drug: Standard treatment（SoC）

First Posted Date: 2023-08-07

Last Posted Date: 2024-01-31

Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Target Recruit Count: 124

Registration Number: NCT05978102

Locations: 🇨🇳
The Fourth Affiliated Hospital of Zhejiang University School of Medicine., Yiwu, Zhejiang, China

Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma

Phase 2

Recruiting

Conditions: Metastatic Head-and-neck Squamous-cell Carcinoma
Metastatic Head and Neck Cancer
HNSCC
Recurrent Head and Neck Cancer
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Carcinoma

Interventions: Drug: Ramucirumab
Drug: Pembrolizumab

First Posted Date: 2023-08-07

Last Posted Date: 2024-01-30

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 72

Registration Number: NCT05980000

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: IO102-103

First Posted Date: 2023-08-07

Last Posted Date: 2024-02-13

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 15

Registration Number: NCT05977907

Locations: 🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Providence Cancer Institute, Portland, Oregon, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 2 locations