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 and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

Phase 2

Recruiting

Conditions: Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Minimal Residual Disease

Interventions: Drug: Dasatinib
Drug: Imatinib Mesylate
Other: Laboratory Biomarker Analysis
Drug: Nilotinib
Biological: Pembrolizumab

First Posted Date: 2018-05-04

Last Posted Date: 2024-12-04

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 40

Registration Number: NCT03516279

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
🇺🇸
Bethesda North Hospital, Cincinnati, Ohio, United States

and more 287 locations

REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer

Phase 3

Terminated

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: REGN2810/chemo/ipi
Drug: REGN2810/ipi
Drug: Pembrolizumab

First Posted Date: 2018-05-03

Last Posted Date: 2022-11-16

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 5

Registration Number: NCT03515629

Locations: 🇱🇹
Regeneron Research Site, Vilnius, Lithuania

FPA150 in Patients With Advanced Solid Tumors

Early Phase 1

Terminated

Conditions: Ovarian Cancer
Breast Cancer
Endometrial Cancer
Advanced Solid Tumors

Interventions: Biological: FPA150
Biological: Pembrolizumab

First Posted Date: 2018-05-02

Last Posted Date: 2024-11-22

Lead Sponsor: Five Prime Therapeutics, Inc.

Target Recruit Count: 95

Registration Number: NCT03514121

Locations: 🇺🇸
Honor Health, Scottsdale, Arizona, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States

and more 15 locations

Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

Phase 2

Terminated

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Pembrolizumab
Drug: Ibrutinib

First Posted Date: 2018-05-02

Last Posted Date: 2024-11-28

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

Target Recruit Count: 5

Registration Number: NCT03514017

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

Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors

Phase 1

Terminated

Conditions: Gastroesophageal Junction Adenocarcinoma
Gastric Cancer
Solid Tumor
Hepatocellular Carcinoma

Interventions: Drug: Vorolanib
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2018-04-27

Last Posted Date: 2020-07-29

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 16

Registration Number: NCT03511222

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Trial of Pembrolizumab in Metastatic Castration Resistant Prostate Cancer

Phase 2

Recruiting

Conditions: Castration-resistant Prostate Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-04-24

Last Posted Date: 2020-07-22

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 100

Registration Number: NCT03506997

Locations: 🇬🇧
The Royal Marsden Hospital, Sutton, Surrey, United Kingdom

A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

Phase 2

Active, not recruiting

Conditions: Pharmacokinetics of Zolbetuximab
Gastric Cancer
Pharmacokinetics of Oxaliplatin
Gastro-esophageal Junction (GEJ) Cancer
Pharmacokinetics of Fluorouracil Bolus (5-FU)

Interventions: Drug: zolbetuximab
Drug: oxaliplatin
Drug: Pembrolizumab
Drug: leucovorin
Drug: fluorouracil
Drug: folinic acid
Drug: nivolumab
Drug: Docetaxel

First Posted Date: 2018-04-23

Last Posted Date: 2024-12-24

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 143

Registration Number: NCT03505320

Locations: 🇫🇷
Site FR33003, Pessac, Nouvelle-Aquitaine, France
🇫🇷
Site FR33002, Poitiers, Nouvelle-Aquitaine, France
🇫🇷
Site FR33001, Brest, France

and more 15 locations

Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases

Phase 2

Terminated

Conditions: Indolent B-Cell Non-Hodgkin Lymphoma
Marginal Zone Lymphoma
Follicular Lymphoma

Interventions: Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab

First Posted Date: 2018-04-13

Last Posted Date: 2024-12-31

Lead Sponsor: University of Washington

Target Recruit Count: 9

Registration Number: NCT03498612

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Pembrolizumab in Combination With Paclitaxel in the Hormone Receptor-positive Metastatic Breast Cancer With High Tumor Mutational Burden Selected by Whole Exome Sequencing: Korean Cancer Study Group Trial (KCSG BR20-16)

Phase 2

Conditions: Metastatic Breast Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-04-10

Last Posted Date: 2022-03-15

Lead Sponsor: Yonsei University

Target Recruit Count: 30

Registration Number: NCT03492918

Locations: 🇰🇷
Yonsei Cancer Center at Yonsei University Health System, Seoul, Korea, Republic of

BDB001-101: Clinical Study of BDB001 as a Mono-therapy or in Combination With Pembrolizumab

Phase 1

Active, not recruiting

Conditions: Tumor, Solid

Interventions: Drug: BDB001
Drug: Pembrolizumab

First Posted Date: 2018-04-03

Last Posted Date: 2024-04-23

Lead Sponsor: Eikon Therapeutics

Target Recruit Count: 50

Registration Number: NCT03486301

Locations: 🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
Atlantic Health, Morristown, New Jersey, United States
🇺🇸
NEXT Oncology, San Antonio, Texas, United States

and more 2 locations

Drug Development Updates

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