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 ...

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
-

Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors

First Posted Date
2024-07-10
Last Posted Date
2024-07-10
Lead Sponsor
Vasgene Therapeutics, Inc
Target Recruit Count
700
Registration Number
NCT06493552

Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer

First Posted Date
2024-07-09
Last Posted Date
2024-10-03
Lead Sponsor
Dustin Deming
Target Recruit Count
23
Registration Number
NCT06493019
Locations
🇺🇸

University of Wisconsin, Madison, Wisconsin, United States

A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL

First Posted Date
2024-07-03
Last Posted Date
2024-12-11
Lead Sponsor
Rita Assi
Target Recruit Count
24
Registration Number
NCT06484920
Locations
🇺🇸

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

🇺🇸

Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, United States

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)

First Posted Date
2024-07-03
Last Posted Date
2024-11-25
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
98
Registration Number
NCT06483334
Locations
🇪🇸

Hospital Universitari Vall d'Hebron-Oncology ( Site 4767), Barcelona, Spain

🇺🇸

University of California San Francisco HDFCCC ( Site 4044), San Francisco, California, United States

🇺🇸

Indiana University Melvin and Bren Simon Cancer Center ( Site 4011), Indianapolis, Indiana, United States

and more 16 locations

An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2024-06-28
Last Posted Date
2024-12-19
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
240
Registration Number
NCT06480552
Locations
🇺🇸

Teva Investigational Site 12016, Chicago, Illinois, United States

🇺🇸

Teva Investigational Site 12015, Detroit, Michigan, United States

🇺🇸

Teva Investigational Site 12058, Pittsburgh, Pennsylvania, United States

and more 3 locations

Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

First Posted Date
2024-06-26
Last Posted Date
2024-11-20
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
15
Registration Number
NCT06475235
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Substudy 06C: A Study of Sacituzumab Tirumotecan (MK-2870) With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)

First Posted Date
2024-06-24
Last Posted Date
2024-12-02
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
130
Registration Number
NCT06469944
Locations
🇺🇸

University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927), Tucson, Arizona, United States

🇧🇷

Liga Norte Riograndense Contra o Câncer ( Site 6303), Natal, Rio Grande Do Norte, Brazil

🇩🇪

Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 6807), Hamburg, Germany

and more 16 locations
© Copyright 2024. All Rights Reserved by MedPath