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

PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Phase 1

Terminated

Conditions: Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy
Drug: Chemotherapy

First Posted Date: 2016-06-30

Last Posted Date: 2022-01-13

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 3

Registration Number: NCT02819752

Locations: 🇬🇧
Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

Phase 3

Completed

Conditions: Triple Negative Breast Cancer (TNBC)

Interventions: Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Gemcitabine
Drug: Carboplatin
Drug: Normale Saline Solution

First Posted Date: 2016-06-30

Last Posted Date: 2024-11-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 882

Registration Number: NCT02819518

Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma

Phase 1

Terminated

Conditions: Melanoma

Interventions: Drug: Pembrolizumab
Drug: Vemurafenib
Drug: Cobimetinib

First Posted Date: 2016-06-29

Last Posted Date: 2022-01-03

Lead Sponsor: Yana Najjar

Target Recruit Count: 9

Registration Number: NCT02818023

Locations: 🇺🇸
UPMC Cancer Center Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma and Other Malignant Neoplasms of Skin
Metastatic Melanoma

Interventions: Drug: Azacitidine
Drug: Pembrolizumab

First Posted Date: 2016-06-28

Last Posted Date: 2024-07-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT02816021

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Phase 3

Active, not recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Lenvatinib
Drug: Sunitinib
Drug: Everolimus
Drug: Pembrolizumab

First Posted Date: 2016-06-23

Last Posted Date: 2024-11-01

Lead Sponsor: Eisai Inc.

Target Recruit Count: 1069

Registration Number: NCT02811861

Locations: 🇮🇱
Chaim Sheba Medical Center, Ramat-Gan, Israel
🇯🇵
Facility #2, Tokyo, Japan
🇺🇸
Mount Sinai Medical Center, Miami Beach, Florida, United States

and more 159 locations

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Phase 1

Completed

Conditions: Advanced/Metastatic Tumors

Interventions: Drug: Tiragolumab
Drug: Atezolizumab
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Capecitabine
Drug: Bevacizumab
Drug: Cisplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Etoposide

First Posted Date: 2016-06-09

Last Posted Date: 2024-12-05

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 518

Registration Number: NCT02794571

Locations: 🇰🇷
Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of
🇺🇸
Henry Ford Hospital, Detroit, Michigan, United States
🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 25 locations

Imaging FDG Flare in Melanoma

Completed

Conditions: Metastatic Melanoma

First Posted Date: 2016-06-07

Last Posted Date: 2024-11-08

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 21

Registration Number: NCT02791594

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)(MK-3475-199/KEYNOTE-199)

Phase 2

Completed

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Biological: Pembrolizumab

First Posted Date: 2016-06-01

Last Posted Date: 2024-11-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 388

Registration Number: NCT02787005

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

Phase 2

Completed

Conditions: Mesothelioma

Interventions: Drug: Cisplatin
Drug: Pemetrexed
Drug: Pembrolizumab

First Posted Date: 2016-05-26

Last Posted Date: 2024-12-10

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 520

Registration Number: NCT02784171

Locations: 🇨🇦
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
🇫🇷
Institut Gustave-Roussy, Villejuif, FR, France
🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada

and more 53 locations

An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: GSK3326595
Drug: Pembrolizumab

First Posted Date: 2016-05-26

Last Posted Date: 2023-12-13

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 288

Registration Number: NCT02783300

Locations: 🇳🇱
GSK Investigational Site, Rotterdam, Netherlands

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