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 of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer

Phase 1

Completed

Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer

Interventions: Drug: Mirvetuximab soravtansine
Drug: Bevacizumab
Drug: Pegylated Liposomal Doxorubicin
Drug: Pembrolizumab
Drug: Carboplatin

First Posted Date: 2015-11-17

Last Posted Date: 2024-06-14

Lead Sponsor: ImmunoGen, Inc.

Target Recruit Count: 264

Registration Number: NCT02606305

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇧🇪
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Leuvens Kankerinstituut, Leuven, Belgium
🇺🇸
The Ohio State University, Hilliard, Ohio, United States

and more 9 locations

Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma

Early Phase 1

Active, not recruiting

Conditions: Smoldering Plasma Cell Myeloma

Interventions: Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab

First Posted Date: 2015-11-13

Last Posted Date: 2024-07-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT02603887

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Proof of Principle Study of Pembrolizumab With SBRT in TKI mRCC Patients

Phase 2

Completed

Conditions: Stage IV Renal Cell Cancer AJCC V7

Interventions: Drug: Pembrolizumab
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2015-11-09

Last Posted Date: 2021-09-01

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 4

Registration Number: NCT02599779

Locations: 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada

Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

Phase 1

Completed

Conditions: Metastatic Renal Cell Carcinoma
Advanced Gastric Adenocarcinoma
Advanced Urothelial Carcinoma
Metastatic Colorectal Adenocarcinoma

Interventions: Drug: ibrutinib
Drug: everolimus
Drug: docetaxel
Drug: paclitaxel
Drug: pembrolizumab
Drug: cetuximab

First Posted Date: 2015-11-06

Last Posted Date: 2023-11-18

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 263

Registration Number: NCT02599324

Locations: 🇺🇸
Whittingham Cancer Center at Norwalk Hospital /ID# 1128-0411, Norwalk, Connecticut, United States
🇬🇧
Sarah Cannon Research Institute /ID# 1128-1079, London, England, United Kingdom
🇺🇸
Franciscan Health Indianapolis /ID# 1128-1125, Indianapolis, Indiana, United States

and more 62 locations

MRI and PET to Assess Pembrolizumab Response

Early Phase 1

Terminated

Conditions: Malignant Melanoma, Metastatic

Interventions: Drug: Pembrolizumab
Drug: FLT PET

First Posted Date: 2015-10-29

Last Posted Date: 2022-12-30

Lead Sponsor: Columbia University

Target Recruit Count: 6

Registration Number: NCT02591654

Locations: 🇺🇸
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York, United States

Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine: Integration of Molecular Subtypes Through Integrative Genomic Analysis

Phase 2

Completed

Conditions: Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma

Interventions: Drug: pembrolizumab

First Posted Date: 2015-10-28

Last Posted Date: 2023-05-09

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 80

Registration Number: NCT02589496

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Korea, Republic of

Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumors

Interventions: Drug: Birinapant
Drug: Pembrolizumab

First Posted Date: 2015-10-27

Last Posted Date: 2021-01-14

Lead Sponsor: Medivir

Target Recruit Count: 34

Registration Number: NCT02587962

Locations: 🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
🇺🇸
UCLA Dept of Medicine-Hematology/Oncology, Santa Monica, California, United States

and more 6 locations

Pembrolizumab and Palliative Radiotherapy in Lung

Phase 1

Completed

Conditions: Thoracic Tumours

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy

First Posted Date: 2015-10-27

Last Posted Date: 2024-05-14

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 24

Registration Number: NCT02587455

Locations: 🇬🇧
NIHR Biomedical Research Centre at RM and ICR (https://www.cancerbrc.org/), Sutton, United Kingdom

Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer

Phase 2

Withdrawn

Conditions: Rectal Cancer
Rectal Neoplasm

Interventions: Drug: Pembrolizumab
Drug: Capecitabine
Radiation: Radiation Therapy

First Posted Date: 2015-10-26

Last Posted Date: 2017-01-20

Lead Sponsor: Osama Rahma, MD

Registration Number: NCT02586610

Pembrolizumab in Untreated Extensive SCLC

Phase 2

Completed

Conditions: Small Cell Lung Cancer (SCLC)

Interventions: Drug: Pembrolizumab
Drug: cis/carboplatin and etoposide

First Posted Date: 2015-10-20

Last Posted Date: 2023-12-11

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 125

Registration Number: NCT02580994

Locations: 🇮🇹
Ospedale S. Luigi Gonzaga - Universita Di Torino, Orbassano, Italy
🇫🇷
Centre Hospitalier d'Avignon - Hopital Duffaut, Avignon, France
🇫🇷
Centre Hopitalier Intercommunal De Creteil, Créteil, France

and more 15 locations

Drug Development Updates

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