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

Vaccination With Flt3L, Radiation, and Poly-ICLC

Phase 1

Recruiting

Conditions: Non-Hodgkin's Lymphoma
Metastatic Breast Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Flt3L
Radiation: Radiation
Drug: Poly ICLC

First Posted Date: 2018-12-28

Last Posted Date: 2024-01-30

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 56

Registration Number: NCT03789097

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

Phase 1

Recruiting

Conditions: Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease

Interventions: Drug: MRTX849
Drug: Pembrolizumab
Drug: Cetuximab
Drug: Afatinib

First Posted Date: 2018-12-24

Last Posted Date: 2024-06-21

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 822

Registration Number: NCT03785249

Locations: 🇺🇸
Local Institution - 001-873-A, Tucson, Arizona, United States
🇺🇸
Local Institution - 001-840-B, Bellflower, California, United States
🇺🇸
Local Institution - 001-850-K, Dublin, California, United States

and more 211 locations

Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer

Phase 1

Active, not recruiting

Conditions: Cervical Cancer

Interventions: Drug: Tisotumab Vedotin
Drug: Bevacizumab
Drug: Pembrolizumab
Drug: Carboplatin

First Posted Date: 2018-12-24

Last Posted Date: 2024-02-12

Lead Sponsor: Seagen Inc.

Target Recruit Count: 214

Registration Number: NCT03786081

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

and more 64 locations

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)

Phase 2

Completed

Conditions: Advanced Melanoma

Interventions: Drug: lenvatinib
Biological: pembrolizumab

First Posted Date: 2018-12-14

Last Posted Date: 2024-10-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 103

Registration Number: NCT03776136

Locations: 🇺🇸
John Wayne Cancer Institute ( Site 0301), Santa Monica, California, United States
🇺🇸
Advocate Medical Group-Park Ridge ( Site 0313), Park Ridge, Illinois, United States
🇺🇸
Southeast Nebraska Cancer Center ( Site 0316), Lincoln, Nebraska, United States

and more 20 locations

PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non Small Cell Lung Cancer
Non Small Cell Lung Cancer Metastatic
Non-Small Cell Carcinoma of Lung, TNM Stage 4

Interventions: Radiation: Radiotherapy
Drug: Pembrolizumab
Drug: Chemotherapy

First Posted Date: 2018-12-13

Last Posted Date: 2023-12-18

Lead Sponsor: UNICANCER

Target Recruit Count: 327

Registration Number: NCT03774732

Locations: 🇫🇷
Hôpital Simone Veil Blois, Blois, France
🇫🇷
Centre Hospitalier Dr Jean-Eric TECHER, Calais, France
🇫🇷
CHRU de Brest, Brest, France

and more 53 locations

MG1-MAGEA3 With Ad-MAGEA3 and Pembrolizumab in Patients With Previously Treated Metastatic Melanoma or Cutaneous Squamous Cell Carcinoma

Phase 1

Withdrawn

Conditions: Metastatic Melanoma
Squamous Cell Skin Carcinoma

Interventions: Drug: Ad-MAGEA3
Drug: MG1-MAGEA3
Drug: Pembrolizumab
Drug: Cyclophosphamide

First Posted Date: 2018-12-12

Last Posted Date: 2021-04-06

Lead Sponsor: Turnstone Biologics, Corp.

Registration Number: NCT03773744

Combination Therapy With NC-6004 and Pembrolizumab in Head and Neck Cancer Subjects Who Have Failed Platinum Regimen

Phase 2

Conditions: SCCHN

Interventions: Drug: NC-6004
Drug: Pembrolizumab

First Posted Date: 2018-12-11

Last Posted Date: 2021-03-17

Lead Sponsor: NanoCarrier Co., Ltd.

Target Recruit Count: 136

Registration Number: NCT03771820

Locations: 🇨🇿
0701, Brno, Czechia
🇨🇳
0404, Taichung City, Taiwan
🇷🇺
0801, Ekaterinburg, Russian Federation

and more 20 locations

Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC

Not Applicable

Recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Procedure: microwave ablation

First Posted Date: 2018-12-07

Last Posted Date: 2024-06-25

Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Target Recruit Count: 100

Registration Number: NCT03769129

Locations: 🇨🇳
zhang Zhenfeng, Guangzhou, Guangdong, China

MRD-guided Treatment in NPM1mut AML Patients

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Pembrolizumab
Drug: Azacitidine

First Posted Date: 2018-12-07

Last Posted Date: 2024-11-06

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 28

Registration Number: NCT03769532

Locations: 🇩🇪
Klinikum Chemnitz, Chemnitz, Germany
🇩🇪
Universitätsklinikum Dresden, Dresden, Germany
🇩🇪
Universitätsklinikum Heidelberg, Heidelberg, Germany

and more 7 locations

Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)

Phase 1

Terminated

Conditions: Epstein-Barr Viraemia
Nasopharyngeal Neoplasms
Epstein-Barr Virus Infections
Nasopharyngeal Carcinoma
Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)

Interventions: Biological: Tabelecleucel
Biological: Pembrolizumab

First Posted Date: 2018-12-07

Last Posted Date: 2024-11-14

Lead Sponsor: Atara Biotherapeutics

Target Recruit Count: 12

Registration Number: NCT03769467

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Stanford Hospital and Clinics, Palo Alto, California, United States

and more 4 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy