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

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Phase 1

Recruiting

Conditions: Endometrial Cancer
Breast Cancer
Advanced Malignant Neoplasm
Ovarian Cancer
Lung Cancer
Prostate Cancer
Other Cancer
Locally Advanced
Advanced Solid Tumor
Metastatic Cancer

Interventions: Drug: PC14586
Drug: pembrolizumab

First Posted Date: 2020-10-14

Last Posted Date: 2024-12-04

Lead Sponsor: PMV Pharmaceuticals, Inc

Target Recruit Count: 230

Registration Number: NCT04585750

Locations: 🇦🇺
Monash Medical Centre, Clayton, Victoria, Australia
🇦🇺
Linear Clinical Research, Nedlands, Western Australia, Australia
🇺🇸
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States

and more 63 locations

Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

Phase 2

Completed

Conditions: Lung Cancer, Non-Small Cell

Interventions: Drug: Pembrolizumab
Drug: Dostarlimab
Drug: Chemotherapy

First Posted Date: 2020-10-09

Last Posted Date: 2024-12-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 243

Registration Number: NCT04581824

Locations: 🇨🇳
GSK Investigational Site, Taipei, Taiwan

Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer

Phase 1

Active, not recruiting

Conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Salivary Gland Carcinoma
Stage III Major Salivary Gland Cancer AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Unresectable Head and Neck Squamous Cell Carcinoma
Unresectable Laryngeal Squamous Cell Carcinoma
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Elimusertib
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Other: Quality-of-Life Assessment
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2020-10-06

Last Posted Date: 2024-12-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 7

Registration Number: NCT04576091

Locations: 🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States

and more 8 locations

Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer

Phase 2

Recruiting

Conditions: Low Grade Serous Carcinoma
Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2020-10-05

Last Posted Date: 2024-11-15

Lead Sponsor: North Eastern German Society of Gynaecological Oncology

Target Recruit Count: 33

Registration Number: NCT04575961

Locations: 🇩🇪
Kliniken Essen Mitte, Essen, Germany
🇩🇪
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany

Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)

Phase 2

Not yet recruiting

Conditions: Prostate Cancer

Interventions: Drug: pembrolizumab
Radiation: Stereotactic body radiation therapy
Drug: Short-term androgen deprivation therapy
Procedure: Radical Prostatectomy

First Posted Date: 2020-09-29

Last Posted Date: 2024-11-19

Lead Sponsor: Duke University

Target Recruit Count: 39

Registration Number: NCT04569461

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors

Phase 1

Terminated

Conditions: Locally Advanced or Metastatic Solid Tumors

Interventions: Biological: W0180
Drug: Pembrolizumab

First Posted Date: 2020-09-25

Last Posted Date: 2024-01-31

Lead Sponsor: Pierre Fabre Medicament

Target Recruit Count: 33

Registration Number: NCT04564417

Locations: 🇫🇷
IGR, Villejuif, Villejuif, France
🇪🇸
CUN, Pamplona, Pamplona, Spain
🇫🇷
IUCT, Toulouse, Toulouse, France

and more 2 locations

Phase 2 Study of Neoadjuvant PEMbrolizumab Before Radical PROstatectomy in High-risk Prostate Cancer Patients

Phase 2

Conditions: Prostate Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2020-09-25

Last Posted Date: 2020-09-25

Lead Sponsor: IRCCS San Raffaele

Target Recruit Count: 59

Registration Number: NCT04565496

Locations: 🇮🇹
IRCCS Ospedale San Raffaele, Milan, Italy
🇮🇹
Ospedale San Raffaele, Milan, Italy

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

Phase 1

Recruiting

Conditions: Urinary Bladder Neoplasm
Triple Negative Breast Neoplasms
Hormone Receptor Positive, HER2-negative Neoplasms
Hormone Receptor Positive, HER2-low Neoplasms
Breast Neoplasms
Non-Small-Cell Lung Neoplasms
Ovarian Neoplasm
Advanced Solid Tumor