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

BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Phase 2

Recruiting

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: Drug: BXCL701
Drug: Pembrolizumab

First Posted Date: 2022-09-29

Last Posted Date: 2023-08-21

Lead Sponsor: Georgetown University

Target Recruit Count: 43

Registration Number: NCT05558982

Locations: 🇺🇸
Medstar Washington Hospital Center, Washington, District of Columbia, United States
🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

Phase 3

Recruiting

Conditions: Metastatic Non Small Cell Lung Cancer

Interventions: Drug: Datopotamab Deruxtecan
Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin

First Posted Date: 2022-09-27

Last Posted Date: 2024-11-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 1170

Registration Number: NCT05555732

Locations: 🇺🇸
Florida Cancer Specialists-North, Saint Petersburg, Florida, United States
🇯🇵
Osaka International Cancer Institute, Osaka, Japan
🇺🇸
Southern Cancer Center Pc, Daphne, Alabama, United States

and more 206 locations

Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

Phase 2

Recruiting

Conditions: Neck Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-09-23

Last Posted Date: 2022-09-23

Lead Sponsor: City Clinical Oncology Hospital No 1

Target Recruit Count: 120

Registration Number: NCT05551767

Locations: 🇷🇺
City clinical oncology hospital 1, Moscow, Russian Federation
🇷🇺
Moscow Clinical Scientific Center named after Loginov, Moscow, Russian Federation
🇷🇺
Moscow City Oncology Hospital No 62, Moscow, Russian Federation

Efficacy and Safety Study of OMTX705, Monotherapy and Pembrolizumab-combined, in Subjects With Advanced Solid Tumors.

Phase 1

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: OMTX705
Drug: Pembrolizumab

First Posted Date: 2022-09-21

Last Posted Date: 2024-02-05

Lead Sponsor: Oncomatryx Biopharma S.L.

Target Recruit Count: 120

Registration Number: NCT05547321

Locations: 🇪🇸
Onkologikoa, San Sebastián, Spain
🇪🇸
Hospital MD Anderson, Madrid, Spain
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 5 locations

Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma

Phase 2

Withdrawn

Conditions: Mucosal Melanoma

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2022-09-19

Last Posted Date: 2024-06-26

Lead Sponsor: Melanoma Institute Australia

Registration Number: NCT05545969

Locations: 🇦🇺
Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia

A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers

Phase 1

Recruiting

Conditions: Carcinoma, Renal Cell
Cutaneous Melanoma
Carcinoma, Ovarian Epithelial
Nasopharyngeal Carcinoma
Carcinoma, Thymic
Anal Cancer
Squamous Cell Carcinoma of Head and Neck
Esophagogastric Cancer
Triple Negative Breast Neoplasms
Carcinoma, Non-Small-Cell Lung

Interventions: Drug: KFA115
Drug: pembrolizumab

First Posted Date: 2022-09-19

Last Posted Date: 2024-11-15

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 180

Registration Number: NCT05544929

Locations: 🇺🇸
NYU School of Medicine, New York, New York, United States
🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸
SCRI Oncology Partners, Nashville, Tennessee, United States

and more 2 locations

Pembrolizumab Plus CRT Followed by Surgery in Upper ESCC

Phase 1

Recruiting

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-09-15

Last Posted Date: 2022-09-15

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Target Recruit Count: 40

Registration Number: NCT05541445

Locations: 🇨🇳
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer

Phase 2

Not yet recruiting

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

Interventions: Biological: Alpha-type-1 Polarized Dendritic Cells
Procedure: Biopsy
Procedure: Computed Tomography
Procedure: Leukapheresis
Biological: Pembrolizumab
Other: Quality-of-Life Assessment

First Posted Date: 2022-09-14

Last Posted Date: 2024-12-13

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 19

Registration Number: NCT05539365

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: BAY3375968
Drug: Pembrolizumab

First Posted Date: 2022-09-13

Last Posted Date: 2024-12-20

Lead Sponsor: Bayer

Target Recruit Count: 354

Registration Number: NCT05537740

Locations: 🇫🇷
Institut Gustave Roussy - Hematologie, Villejuif cedex, France
🇺🇸
The University of Chicago Medical Center (UCMC), Chicago, Illinois, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States

and more 24 locations

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Biological: mRNA-4359
Biological: Pembrolizumab

First Posted Date: 2022-09-09

Last Posted Date: 2024-11-20

Lead Sponsor: ModernaTX, Inc.

Target Recruit Count: 194

Registration Number: NCT05533697

Locations: 🇺🇸
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States
🇺🇸
George Washington University, Washington, District of Columbia, United States

and more 23 locations

Drug Development Updates

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