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
-

Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin

First Posted Date
2024-08-28
Last Posted Date
2024-12-19
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
128
Registration Number
NCT06576037
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Perioperative Immunotherapy for NSCLC (ECTOP-1030)

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-08-27
Last Posted Date
2024-08-27
Lead Sponsor
Fudan University
Target Recruit Count
200
Registration Number
NCT06572722

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49%

First Posted Date
2024-08-20
Last Posted Date
2024-12-16
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
800
Registration Number
NCT06561386
Locations
🇺🇸

Saint Elizabeth Medical Center Edgewood, Edgewood, Kentucky, United States

🇺🇸

Local Institution - 0369, Canton, Ohio, United States

🇧🇷

Local Institution - 0382, Fortaleza, Ceará, Brazil

and more 214 locations

LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)

First Posted Date
2024-08-19
Last Posted Date
2024-10-22
Lead Sponsor
NovoCure GmbH
Target Recruit Count
69
Registration Number
NCT06558799
Locations
🇦🇹

Universitätsklinik f. Innere Medizin III, Salzburg, Austria

OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial

First Posted Date
2024-08-16
Last Posted Date
2024-11-15
Lead Sponsor
University of Florida
Target Recruit Count
20
Registration Number
NCT06558214
Locations
🇺🇸

UF Health Shands Hospital, Gainesville, Florida, United States

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

First Posted Date
2024-08-16
Last Posted Date
2024-12-20
Lead Sponsor
NovoCure GmbH
Target Recruit Count
741
Registration Number
NCT06556563
Locations
🇺🇸

University of Kentucky Medical Center, Lexington, Kentucky, United States

🇺🇸

Swedish Medical Center, Seattle, Washington, United States

🇺🇸

UF Health Neuromedicine, Gainesville, Florida, United States

Study of XB010 in Subjects With Solid Tumors

First Posted Date
2024-08-09
Last Posted Date
2024-11-08
Lead Sponsor
Exelixis
Target Recruit Count
350
Registration Number
NCT06545331
Locations
🇺🇸

Exelixis Clinical Site #4, Duarte, California, United States

🇺🇸

Exelixis Clinical Site #3, Huntersville, North Carolina, United States

🇺🇸

Exelixis Clinical Site #1, Austin, Texas, United States

and more 1 locations

A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

First Posted Date
2024-08-09
Last Posted Date
2024-11-14
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
150
Registration Number
NCT06545955
Locations
🇺🇸

Ferring Investigational Site, Los Angeles, California, United States

A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients

First Posted Date
2024-08-06
Last Posted Date
2024-12-16
Lead Sponsor
Microbiotica Ltd
Target Recruit Count
40
Registration Number
NCT06540391
Locations
🇫🇷

Centre Georges Francois Leclerc, Dijon, France

🇫🇷

CHU de Lille - Hopital Claude Huriez, Lille, France

🇫🇷

Centre Leon Berard, Lyon, France

and more 16 locations

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer

First Posted Date
2024-08-05
Last Posted Date
2024-10-15
Lead Sponsor
Essen Biotech
Target Recruit Count
85
Registration Number
NCT06538012
Locations
🇨🇳

District One Hospital, Beijing, Beijing, China

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