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 Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Phase 1

Recruiting

Conditions: KRAS P.G12C

Interventions: Drug: D3S-001
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Cetuximab
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2022-06-08

Last Posted Date: 2024-12-27

Lead Sponsor: D3 Bio (Wuxi) Co., Ltd

Target Recruit Count: 392

Registration Number: NCT05410145

Locations: 🇪🇸
D3 Bio Investigative Site, Valencia, Spain

Pembrolizumab in Muscle-invasive Bladder Cancer

Phase 2

Recruiting

Conditions: Muscle Invasive Bladder Carcinoma
Localized Cancer
Urothelial Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-06-06

Last Posted Date: 2024-10-11

Lead Sponsor: Matthew Galsky

Target Recruit Count: 46

Registration Number: NCT05406713

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
🇺🇸
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States

and more 1 locations

Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above

Phase 2

Recruiting

Conditions: Classical Hodgkin Lymphoma

Interventions: Drug: Pembrolizumab
Drug: Doxorubicin
Drug: Vinblastine
Drug: Dacarbazine
Drug: Brentuximab vedotin

First Posted Date: 2022-06-03

Last Posted Date: 2024-07-03

Lead Sponsor: University of Virginia

Target Recruit Count: 44

Registration Number: NCT05404945

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)

Phase 1

Terminated

Conditions: Advanced Solid Tumors

Interventions: Drug: MK-1088
Biological: Pembrolizumab

First Posted Date: 2022-05-27

Last Posted Date: 2024-11-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 27

Registration Number: NCT05394350

Locations: 🇨🇭
Cantonal Hospital St.Gallen ( Site 0403), st.Gallen, Sankt Gallen, Switzerland
🇨🇭
Ospedale Regionale Bellinzona e Valli ( Site 0400), Bellinzona, Ticino, Switzerland
🇩🇰
Rigshospitalet ( Site 0500), Copenhagen, Hovedstaden, Denmark

and more 10 locations

Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors

Conditions: KRAS G12V Mutant Advanced Epithelial Cancers

First Posted Date: 2022-05-25

Last Posted Date: 2024-10-26

Lead Sponsor: Providence Health & Services

Registration Number: NCT05389514

Pembrolizumab and Photodynamic Therapy in Previously Treated Metastatic Esophageal Squamous Cell Carcinoma

Phase 2

Not yet recruiting

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Sinoporphyrin Sodium
Procedure: Photodynamic therapy

First Posted Date: 2022-05-23

Last Posted Date: 2022-11-28

Lead Sponsor: Peking University

Target Recruit Count: 54

Registration Number: NCT05386056

Locations: 🇨🇳
Beijing Cancer Hospital & Institute, Beijing, Beijing, China

Neoadjuvant/Adjuvant Pembrolizumab Plus Chemotherapy

Phase 2

Active, not recruiting

Conditions: Non Small Cell Lung Cancer
Immune Checkpoint Inhibitor
Neoadjuvant Therapy

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-05-20

Last Posted Date: 2024-04-23

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 80

Registration Number: NCT05383716

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, China

Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Small Cell Lung Cancer Extensive Stage

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab
Drug: Etoposide
Drug: Carboplatin

First Posted Date: 2022-05-20

Last Posted Date: 2024-02-20

Lead Sponsor: Fundación GECP

Target Recruit Count: 85

Registration Number: NCT05384015

Locations: 🇪🇸
Hospital General Universitario de Valencia, Valencia, Spain
🇪🇸
ICO Badalona, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
🇪🇸
Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain

and more 15 locations

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001)

Phase 1

Active, not recruiting

Conditions: Advanced or Metastatic Solid Tumors

Interventions: Biological: MK-1484
Biological: Pembrolizumab

First Posted Date: 2022-05-19

Last Posted Date: 2024-11-14

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 70

Registration Number: NCT05382325

Locations: 🇮🇱
Rambam Health Care Campus-Oncology ( Site 0021), Haifa, Israel
🇮🇱
Sheba Medical Center-ONCOLOGY ( Site 0020), Ramat Gan, Israel
🇳🇱
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0037), Utrecht, Netherlands

and more 5 locations

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Phase 3

Active, not recruiting

Conditions: Triple Negative Breast Cancer
PD-L1 Positive

Interventions: Drug: Sacituzumab Govitecan-hziy
Drug: Pembrolizumab
Drug: Paclitaxel
Drug: nab-Paclitaxel
Drug: Gemcitabine
Drug: Carboplatin

First Posted Date: 2022-05-19

Last Posted Date: 2024-12-24

Lead Sponsor: Gilead Sciences

Target Recruit Count: 440

Registration Number: NCT05382286

Locations: 🇺🇸
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
Magee-Womens Hospital of UPMC,5115 Centre Avenue, Pittsburgh, Pennsylvania, United States

and more 501 locations

Drug Development Updates

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