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

Study on MK-3475 Plus Chemotherapy Versus Chemotherapy Alone in Recurrent, Platinum-resistant Ovarian Cancer

Phase 2

Conditions: Ovarian Cancer

Interventions: Drug: Gemcitabine
Drug: Pembrolizumab
Drug: Liposomal Doxorubicin
Drug: Paclitaxel

First Posted Date: 2018-05-29

Last Posted Date: 2018-05-29

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 138

Registration Number: NCT03539328

Locations: 🇮🇹
National Cancer Institute, Milan, Italy

Analysis of the Modulation of the Tumor Microenvironment by MK-3475 (Pembrolizumab) Using a Systems Biology Approach (PEMSYS)

Phase 2

Active, not recruiting

Conditions: Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting

Interventions: Drug: Pembrolizumab
Drug: Pembrolizumab - additional treatment

First Posted Date: 2018-05-23

Last Posted Date: 2023-02-21

Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Target Recruit Count: 30

Registration Number: NCT03534635

Locations: 🇨🇭
CHUV, Lausanne, Switzerland

Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma

Phase 2

Completed

Conditions: Bladder Cancer
Metastatic Urothelial Carcinoma

Interventions: Drug: Cabozantinib
Drug: Pembrolizumab

First Posted Date: 2018-05-23

Last Posted Date: 2024-11-26

Lead Sponsor: University of Utah

Target Recruit Count: 37

Registration Number: NCT03534804

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

Concomitant Immune Check Point Inhibitor With Radiochemotherapy in Head And Neck Cancer

Phase 2

Recruiting

Conditions: Locally Advanced Head and Neck Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-05-22

Last Posted Date: 2024-01-23

Lead Sponsor: Kuwait Cancer Control Center

Target Recruit Count: 50

Registration Number: NCT03532737

Locations: 🇰🇼
Kuwait Cancer Control Center, Kuwait, Kuwait

Re-challenge Pembrolizumab Study as a Second or Further Line in Patients With Advanced NSCLC

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-05-16

Last Posted Date: 2023-04-05

Lead Sponsor: Spanish Lung Cancer Group

Target Recruit Count: 77

Registration Number: NCT03526887

Locations: 🇪🇸
Hospital General Universitario de Elche, Elche, Alicante, Spain
🇪🇸
Hospital Parc Taulí, Sabadell, Barcelona, Spain
🇪🇸
H. Germans Trias i Pujol, Badalona, Barcelona, Spain

and more 16 locations

QUILT 2.023: A Study of N-803 in Combination With Current Standard of Care vs Standard of Care as First-Line Treatment for Patients With Stage 3 or 4 NSCLC.

Phase 3

Active, not recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: N-803 + Pembrolizumab
Drug: N-803 + Carboplatin + Nab-paclitaxel + Pembrolizumab
Drug: N-803 + Cisplatin or Carboplatin + Pembrolizumab + Pemetrexed
Drug: Pembrolizumab
Drug: N-803 + Carboplatin + Nab-paclitaxel + Ipilimumab + Nivolumab
Drug: Cisplatin or Carboplatin + Pembrolizumab + Pemetrexed
Drug: Carboplatin + Nab-paclitaxel or Paclitaxel + Pembrolizumab

First Posted Date: 2018-05-11

Last Posted Date: 2024-08-14

Lead Sponsor: ImmunityBio, Inc.

Target Recruit Count: 1538

Registration Number: NCT03520686

Locations: 🇺🇸
Oncology Consultants, PA, Houston, Texas, United States
🇺🇸
Adventist Health White Memorial, Los Angeles, California, United States
🇺🇸
Genesis Cancer Center, Hot Springs, Arkansas, United States

and more 28 locations

A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Bavituximab

First Posted Date: 2018-05-09

Last Posted Date: 2024-07-17

Lead Sponsor: David Hsieh

Target Recruit Count: 35

Registration Number: NCT03519997

Locations: 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

Phase 2

Active, not recruiting

Conditions: Advanced Non-Small Cell Lung Cancer

Interventions: Biological: Pembrolizumab
Biological: Favezelimab
Drug: Lenvatinib
Drug: Quavonlimab

First Posted Date: 2018-05-07

Last Posted Date: 2024-11-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 318

Registration Number: NCT03516981

Locations: 🇵🇱
Dolnoslaskie Centrum Onkologii. ( Site 0993), Wroclaw, Dolnoslaskie, Poland
🇨🇦
Jewish General Hospital ( Site 0307), Montreal, Quebec, Canada
🇺🇸
University of California Davis Comprehensive Cancer Center ( Site 0137), Sacramento, California, United States

and more 78 locations

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Phase 3

Active, not recruiting

Conditions: Endometrial Neoplasms

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Lenvatinib
Drug: Doxorubicin

First Posted Date: 2018-05-07

Last Posted Date: 2023-10-18

Lead Sponsor: Eisai Inc.

Target Recruit Count: 827

Registration Number: NCT03517449

Locations: 🇺🇸
North Shore University Health System, Evanston, Illinois, United States
🇺🇸
Greater Baltimore Medical Center, Baltimore, Maryland, United States
🇺🇸
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

and more 159 locations

Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)

Phase 3

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: pemetrexed
Biological: pembrolizumab
Drug: carboplatin
Drug: saline solution
Drug: cisplatin

First Posted Date: 2018-05-04

Last Posted Date: 2024-11-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 492

Registration Number: NCT03515837

Locations: 🇨🇳
Tangdu Hospital ( Site 0708), XI An, Shanxi, China
🇨🇳
Southwest Hospital, The Third Military Medical University ( Site 0725), Chongqing, Chongqing, China
🇨🇳
Henan Cancer Hospital ( Site 0711), Zhengzhou, Henan, China

and more 155 locations

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