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

Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma

Phase 2

Recruiting

Conditions: Uveal Melanoma
Ocular Melanoma

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2022-09-01

Last Posted Date: 2024-12-06

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 37

Registration Number: NCT05524935

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension

Phase 3

Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Lenvatinib
Biological: Pembrolizumab
Drug: Placebo

First Posted Date: 2022-08-31

Last Posted Date: 2024-12-04

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 112

Registration Number: NCT05523323

Locations: 🇨🇳
Shanghai East Hospital ( Site 3300), Shanghai, Shanghai, China
🇨🇳
Henan Cancer Hospital ( Site 3309), Zhengzhou, Henan, China
🇨🇳
Chongqing Cancer Hospital ( Site 3327), Chongqing, Chongqing, China

and more 25 locations

Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)

Phase 2

Not yet recruiting

Conditions: Stage III Colorectal Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Recurrent Colorectal Carcinoma
Unresectable Colorectal Carcinoma
Metastatic Microsatellite Stable Colorectal Carcinoma

Interventions: Procedure: Biopsy
Biological: Pembrolizumab
Biological: Therapeutic Autologous Dendritic Cells

First Posted Date: 2022-08-26

Last Posted Date: 2024-04-12

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 20

Registration Number: NCT05518032

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

Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

Phase 1

Active, not recruiting

Conditions: Advanced/Metastatic Solid Tumors
Neoplasms

Interventions: Biological: MK-4464
Biological: Pembrolizumab
Drug: 89Zr-MK-4464

First Posted Date: 2022-08-24

Last Posted Date: 2024-11-15

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 260

Registration Number: NCT05514444

Locations: 🇨🇦
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201), Toronto, Ontario, Canada
🇺🇸
The University of Louisville, James Graham Brown Cancer Center ( Site 0100), Louisville, Kentucky, United States
🇳🇱
Amsterdam UMC, locatie VUmc ( Site 0400), Amsterdam, Noord-Holland, Netherlands

and more 3 locations

TTI-622 and TTI-621 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 2

Recruiting

Conditions: Recurrent ALK Positive Large B-Cell Lymphoma
Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma Associated with Chronic Inflammation
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent Grade 3b Follicular Lymphoma
Recurrent High Grade B-Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements
Recurrent High Grade B-Cell Lymphoma with MYC, BCL2, and BCL6 Rearrangements
Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Ontorpacept
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Drug: Maplirpacept
Procedure: Biopsy

First Posted Date: 2022-08-19

Last Posted Date: 2023-10-12

Lead Sponsor: Mayo Clinic

Target Recruit Count: 62

Registration Number: NCT05507541

Locations: 🇺🇸
University of Iowa, Iowa City, Iowa, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Evaluating Pembrolizumab, Trastuzumab and FLOT as Perioperative Treatment of HER2-positive, Localized Esophagogastric Adenocarcinoma

Phase 2

Active, not recruiting

Conditions: Esophagogastric Adenocarcinoma

Interventions: Drug: Pembrolizumab
Drug: Trastuzumab
Drug: FLOT

First Posted Date: 2022-08-17

Last Posted Date: 2024-05-08

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Target Recruit Count: 31

Registration Number: NCT05504720

Locations: 🇩🇪
Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest, Frankfurt/main, Germany
🇩🇪
Klinikum rechts der Isar der TU München, München, Germany
🇩🇪
MVZ Onkologischer Schwerpunkt, Berlin, Germany

and more 10 locations

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Phase 3

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Zimberelimab
Drug: Pembrolizumab
Drug: Domvanalimab
Drug: Carboplatin
Drug: Cisplatin
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Pemetrexed

First Posted Date: 2022-08-16

Last Posted Date: 2024-11-08

Lead Sponsor: Gilead Sciences

Target Recruit Count: 792

Registration Number: NCT05502237

Locations: 🇦🇷
Clínica Viedma, Viedma, Argentina
🇦🇹
Klinikum Klagenfurt am Woerthersee, Klagenfurt Am Woerthersee, Austria
🇺🇸
Eastern CT Hematology and Oncology Associates, Norwich, Connecticut, United States

and more 218 locations

Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer

Phase 1

Recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage III Lung Cancer

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Procedure: Computed Tomography
Other: Fludeoxyglucose F-18
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Pemetrexed
Procedure: Positron Emission Tomography
Biological: Atezolizumab
Radiation: Radiation Therapy
Biological: Cemiplimab
Other: [18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan
Biological: Ipilimumab
Biological: Nivolumab

First Posted Date: 2022-08-15

Last Posted Date: 2024-10-17

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 25

Registration Number: NCT05501665

Locations: 🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Study of KBA1412 in Participants With Advanced Solid Malignant Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumor Malignancy

Interventions: Drug: KBA1412
Drug: Pembrolizumab

First Posted Date: 2022-08-15

Last Posted Date: 2024-08-28

Lead Sponsor: Kling Biotherapeutics B.V.

Target Recruit Count: 16

Registration Number: NCT05501821

Locations: 🇧🇪
University Hospital Ghent, Ghent, Belgium
🇳🇱
Dutch Cancer Institute AVL, Amsterdam, Netherlands
🇳🇱
Erasmus Medical Center Rotterdam, Rotterdam, Netherlands

and more 2 locations

AK112 in Advanced Non-Small Cell Lung Cancer

Phase 3

Active, not recruiting

Conditions: Advanced Non-small-cell Lung Cancer

Interventions: Drug: AK112
Drug: Pembrolizumab

First Posted Date: 2022-08-12

Last Posted Date: 2023-09-21

Lead Sponsor: Akeso

Target Recruit Count: 398

Registration Number: NCT05499390

Locations: 🇨🇳
Shanghai Pulmonary Hospital, Shanghai, China

Drug Development Updates

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