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

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

Phase 1

Completed

Conditions: Triple Negative Breast Neoplasms

Interventions: Drug: ladiratuzumab vedotin
Drug: Pembrolizumab

First Posted Date: 2017-10-16

Last Posted Date: 2024-12-20

Lead Sponsor: Seagen Inc.

Target Recruit Count: 186

Registration Number: NCT03310957

Locations: 🇩🇪
Marien Hospital Bottrop, Bottrop, Other, Germany
🇩🇪
Klinikum der Universitat Munchen, Munchen, Other, Germany
🇰🇷
Samsung Medical Center, Seoul, Other, Korea, Republic of

and more 47 locations

Sequencing of Stereotactic Ablative Body Radiotherapy in Combination With PD-1 Blockade Using Pembrolizumab in Metastatic Non-Small Cell Lung Carcinoma

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy (SABR)

First Posted Date: 2017-10-12

Last Posted Date: 2022-05-25

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 13

Registration Number: NCT03307759

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
🇨🇦
London Hospital, London, Ontario, Canada

Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Advanced Merkel Cell Carcinoma
Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Metastatic Merkel Cell Carcinoma
Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8

Interventions: Biological: Pembrolizumab
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2017-10-09

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT03304639

Locations: 🇺🇸
Saint Mary's Regional Medical Center, Reno, Nevada, United States
🇺🇸
Knox Community Hospital, Mount Vernon, Ohio, United States
🇺🇸
Licking Memorial Hospital, Newark, Ohio, United States

and more 254 locations

A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma

Phase 2

Terminated

Conditions: Melanoma

Interventions: Drug: Pembrolizumab
Drug: Nivolumab
Drug: Indoximod

First Posted Date: 2017-10-04

Last Posted Date: 2022-09-27

Lead Sponsor: NewLink Genetics Corporation

Target Recruit Count: 21

Registration Number: NCT03301636

Locations: 🇺🇸
Utah Cancer Specialists, Salt Lake City, Utah, United States
🇺🇸
Mayo Clinic - Rochester, Rochester, Minnesota, United States
🇺🇸
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States

and more 1 locations

Pembrolizumab in Elderly Patients With Advanced Lung Cancer

Phase 2

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-09-26

Last Posted Date: 2024-10-23

Lead Sponsor: Spanish Lung Cancer Group

Target Recruit Count: 82

Registration Number: NCT03293680

Locations: 🇪🇸
Hospital Virgen de la Luz, Cuenca, Spain
🇪🇸
Hospital Lucus Agustí, Lugo, Spain
🇪🇸
Fundación Jiménez Díaz, Madrid, Spain

and more 9 locations

Epacadostat and Pembrolizumab in Patients With GIST

Phase 2

Terminated

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: Pembrolizumab
Drug: Epacadostat

First Posted Date: 2017-09-25

Last Posted Date: 2024-06-11

Lead Sponsor: Columbia University

Target Recruit Count: 1

Registration Number: NCT03291054

Locations: 🇺🇸
U-M Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Columbia University Irving Medical Center, New York, New York, United States

Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia

Early Phase 1

Withdrawn

Conditions: Refractory Acute Myeloid Leukemia

Interventions: Drug: pembrolizumab

First Posted Date: 2017-09-25

Last Posted Date: 2019-04-19

Lead Sponsor: Michael Boyiadzis

Registration Number: NCT03291353

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

Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC

Phase 2

Completed

Conditions: Malignant Neoplasm of Breast

Interventions: Drug: Pembrolizumab
Drug: nab-paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide

First Posted Date: 2017-09-21

Last Posted Date: 2021-04-08

Lead Sponsor: Institut fuer Frauengesundheit

Target Recruit Count: 53

Registration Number: NCT03289819

Locations: 🇩🇪
Department of Gynecology, Tübingen University Hospital, Tübingen, Baden-Württemberg, Germany
🇩🇪
Department of Gynecology and Obstetrics, HELIOS Hospital Berlin Buch GmbH, Berlin, Germany
🇩🇪
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH, Bottrop, North Rhine-Westphalia, Germany

and more 1 locations

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

Phase 2

Completed

Conditions: Neuroendocrine Tumors
Neuroendocrine Carcinoma
Neuroendocrine Cancer

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2017-09-21

Last Posted Date: 2024-11-28

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

Target Recruit Count: 20

Registration Number: NCT03290079

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Phase 1

Active, not recruiting

Conditions: Renal Pelvis Neoplasms
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Urologic Neoplasms
Urothelial Cancer
Ureteral Neoplasms
Urethral Neoplasms

Interventions: Drug: enfortumab vedotin (EV)
Drug: pembrolizumab
Drug: cisplatin
Drug: carboplatin
Drug: gemcitabine

First Posted Date: 2017-09-20

Last Posted Date: 2024-12-27

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 348

Registration Number: NCT03288545

Locations: 🇺🇸
Piedmont Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 103 locations

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