MedPath

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
-

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Breast Neoplasm
Breast Cancer Invasive
Breast Cancer Female
Breast Cancer Stage II
Breast Cancer Stage III
Hormone Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Neoplasms
Estrogen Receptor-positive Breast Cancer
Interventions
First Posted Date
2021-08-25
Last Posted Date
2024-01-16
Lead Sponsor
Baylor Breast Care Center
Target Recruit Count
185
Registration Number
NCT05020860
Locations
🇺🇸

Harris Health System - Smith Clinic, Houston, Texas, United States

🇺🇸

O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)

First Posted Date
2021-08-23
Last Posted Date
2024-12-27
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
72
Registration Number
NCT05017012
Locations
🇨🇱

James Lind Centro de Investigación del Cáncer ( Site 0102), Temuco, Araucania, Chile

🇨🇱

FALP-UIDO ( Site 0101), Santiago, Region M. De Santiago, Chile

🇿🇦

Cancercare Rondebosch Oncology-Clinical trials ( Site 0055), Rondebosch, Western Cape, South Africa

and more 19 locations

Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer

Phase 2
Active, not recruiting
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2021-08-20
Last Posted Date
2024-04-09
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
17
Registration Number
NCT05014776
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)

First Posted Date
2021-08-17
Last Posted Date
2024-11-20
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
146
Registration Number
NCT05008224
Locations
🇺🇸

Stanford Cancer Center ( Site 0023), Palo Alto, California, United States

🇺🇸

Northwestern Memorial Hospital ( Site 0002), Chicago, Illinois, United States

🇺🇸

Texas Oncology-Plano East ( Site 0020), Plano, Texas, United States

and more 45 locations

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

Phase 2
Active, not recruiting
Conditions
Endometrial Neoplasms
Uterine Cervical Neoplasms
Squamous Cell Carcinoma of Head and Neck
Urinary Bladder Neoplasms
Cholangiocarcinoma
Esophageal Neoplasms
Ovarian Neoplasms
Triple Negative Breast Neoplasms
Hepatocellular Carcinoma
Gallbladder Neoplasms
Interventions
First Posted Date
2021-08-16
Last Posted Date
2024-10-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
604
Registration Number
NCT05007106
Locations
🇺🇸

Memorial Sloan Kettering - Bergen ( Site 1025), Montvale, New Jersey, United States

🇺🇸

Memorial Sloan Kettering - Monmouth ( Site 1022), Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering - Basking Ridge ( Site 1023), Basking Ridge, New Jersey, United States

and more 70 locations

Study of Pembrolizumab Combined With Anlotinib in the First Line Therapy for R/M HNSCC With CPS≥1

Phase 2
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
First Posted Date
2021-08-11
Last Posted Date
2021-08-11
Lead Sponsor
Shi Yuankai
Target Recruit Count
20
Registration Number
NCT04999800
Locations
🇨🇳

National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults

Phase 1
Active, not recruiting
Conditions
Advanced Solid Tumors
Interventions
Drug: BAY2416964
Drug: Pembrolizumab
First Posted Date
2021-08-10
Last Posted Date
2025-01-10
Lead Sponsor
Bayer
Target Recruit Count
47
Registration Number
NCT04999202
Locations
🇺🇸

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit, Detroit, Michigan, United States

🇺🇸

Florida Cancer Specialists, Altamonte Springs, Florida, United States

🇺🇸

Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 11 locations

Pembrolizumab and Axitinib as Neoadjuvant Therapy for Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

Phase 2
Conditions
Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Interventions
First Posted Date
2021-08-06
Last Posted Date
2021-08-06
Lead Sponsor
Tianjin Medical University Second Hospital
Target Recruit Count
18
Registration Number
NCT04995016
Locations
🇨🇳

Tianjin Medical Unversity Second Hospital, Tianjin, Tianjin, China

Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer

Phase 1
Recruiting
Conditions
Unresectable Metastatic Colorectal Cancer
Interventions
Drug: CYAD-101
Drug: FOLFOX
Drug: Pembrolizumab
First Posted Date
2021-08-05
Last Posted Date
2022-03-09
Lead Sponsor
Celyad Oncology SA
Target Recruit Count
34
Registration Number
NCT04991948
Locations
🇺🇸

Mayo Clinic, Jacksonville, Florida, United States

🇧🇪

UZ Antwerpen, Edegem, Belgium

🇧🇪

UZ Gent, Ghent, Belgium

and more 2 locations

Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC

Phase 2
Recruiting
Conditions
Nsclc
EGF-R Positive Non-Small Cell Lung Cancer
ROS1 Gene Rearrangement
EGFR Activating Mutation
ALK Gene Rearrangement Positive
ROS1 Positive NSCLC - Reactive Oxygen Species 1 Positive Non-Small Cell Lung Cancer
Interventions
First Posted Date
2021-08-04
Last Posted Date
2021-12-08
Lead Sponsor
Dr Joanne CHIU
Target Recruit Count
46
Registration Number
NCT04989322
Locations
🇭🇰

Queen Mary Hospital, Hong Kong, Hong Kong

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