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

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Phase 1

Suspended

Conditions: Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma
Unresectable Triple-Negative Breast Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Decitabine and Cedazuridine
Procedure: Magnetic Resonance Imaging
Drug: Paclitaxel
Biological: Pembrolizumab

First Posted Date: 2023-01-06

Last Posted Date: 2025-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 32

Registration Number: NCT05673200

Locations: 🇺🇸
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

and more 6 locations

Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC

Phase 2

Recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Fecal Microbiota Transplant (FMT)
Drug: Pembrolizumab

First Posted Date: 2023-01-03

Last Posted Date: 2024-12-27

Lead Sponsor: Diwakar Davar

Target Recruit Count: 26

Registration Number: NCT05669846

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Phase I/II Open Label Study Evaluating the Safety and Efficacy of Combining STAT3 Inhibition (TTI-101) With Anti-PD-1 Therapy (Pembrolizumab) in Patients With Recurrent or Metastatic (RM) Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 1

Not yet recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: TTI-101
Drug: Pembrolizumab

First Posted Date: 2022-12-30

Last Posted Date: 2024-07-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 47

Registration Number: NCT05668949

A Study of Oral IRAK-4 Inhibitor CA-4948 in Combination With Pembrolizumab Following Stereotactic Radiosurgery in Patients With Melanoma Brain Metastases

Phase 1

Recruiting

Conditions: Melanoma Metastatic in the Brain

Interventions: Drug: CA-4948
Drug: Pembrolizumab

First Posted Date: 2022-12-30

Last Posted Date: 2024-11-13

Lead Sponsor: University of Florida

Target Recruit Count: 29

Registration Number: NCT05669352

Locations: 🇺🇸
University of Florida, Gainesville, Florida, United States

Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC

Phase 3

Recruiting

Conditions: Non Small Cell Lung Cancer Metastatic

Interventions: Drug: Pembrolizumab biosimilar
Drug: Pembrolizumab

First Posted Date: 2022-12-30

Last Posted Date: 2024-07-16

Lead Sponsor: Laboratorio Elea Phoenix S.A.

Target Recruit Count: 174

Registration Number: NCT05668650

Locations: 🇦🇷
Clínica Viedma, Viedma, Río Negro, Argentina

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Phase 3

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Biological: Pembrolizumab/Vibostolimab

First Posted Date: 2022-12-27

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1594

Registration Number: NCT05665595

Locations: 🇦🇷
Clinica Adventista Belgrano-Oncology ( Site 0211), Caba, Argentina
🇨🇳
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667), Cheng Du, Sichuan, China
🇺🇸
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123), Los Angeles, California, United States

and more 202 locations

Response to Immunotherapy in MMR-deficient Localized Colon Cancer

Phase 2

Completed

Conditions: Colon Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-12-22

Last Posted Date: 2024-08-13

Lead Sponsor: Camilla Qvortrup

Target Recruit Count: 85

Registration Number: NCT05662527

Locations: 🇩🇰
Zealand University Hospital, Roskilde, Denmark

Renal Retention in High Grade Upper Tract Urothelial Cancer

Phase 2

Recruiting

Conditions: Bladder Cancer
Urothelial Carcinoma Bladder
High Grade Urothelial Carcinoma

Interventions: Drug: Enfortumab vedotin
Drug: Pembrolizumab

First Posted Date: 2022-12-19

Last Posted Date: 2024-12-11

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 20

Registration Number: NCT05656235

Locations: 🇺🇸
Johns Hopkins University: Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

A Study Evaluating AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Solid Tumors

Phase 1

Recruiting

Conditions: Non Small Cell Lung Cancer
Melanoma
Renal Cell Carcinoma
Solid Tumor
Squamous Cell Carcinoma of Head and Neck

Interventions: Biological: AB248
Biological: pembrolizumab

First Posted Date: 2022-12-16

Last Posted Date: 2024-12-09

Lead Sponsor: Asher Biotherapeutics, Inc.

Target Recruit Count: 462

Registration Number: NCT05653882

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
UCLA, Los Angeles, California, United States
🇺🇸
UCSF, San Francisco, California, United States

and more 13 locations

A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver

Phase 3

Not yet recruiting

Conditions: Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms

Interventions: Drug: HX008 + TACE
Drug: Temozolomide + TACE
Drug: Pembrolizumab

First Posted Date: 2022-12-13

Last Posted Date: 2022-12-13

Lead Sponsor: Taizhou Hanzhong biomedical co. LTD

Target Recruit Count: 350

Registration Number: NCT05647954

Locations: 🇨🇳
Beijing Cancer hospital, Beijing, Beijing, China

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