Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

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)

Clinical Trials

A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

Phase 2

Recruiting

Conditions: Advanced Solid Tumor
Esophageal Cancer
Metastatic Solid Tumor
Non-small Cell Lung Cancers
SMARCA4 Gene Mutation

Interventions: Drug: PRT3789
Drug: pembrolizumab

First Posted Date: 2024-11-12

Last Posted Date: 2025-05-01

Lead Sponsor: Prelude Therapeutics

Target Recruit Count: 60

Registration Number: NCT06682806

Locations: 🇺🇸
Florida Cancer Specialists, West Palm Beach, Florida, United States
🇺🇸
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research, Nashville, Tennessee, United States
🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States

and more 3 locations

Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients

Phase 2

Recruiting

Conditions: Angiosarcoma of Skin
Angiosarcoma Metastatic

Interventions: Drug: Pembrolizumab plus Lenvatinib

First Posted Date: 2024-11-05

Last Posted Date: 2025-05-13

Lead Sponsor: National Cancer Center, Japan

Target Recruit Count: 38

Registration Number: NCT06673628

Locations: 🇯🇵
University Hospital Kyoto Prefectural University of Medicine, Kyoto, Japan
🇯🇵
Nagoya City University Hospital, Nagoya, Japan
🇯🇵
National Cancer Center Hospital, Tokyo, Japan

Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment

Phase 2

Not yet recruiting

Conditions: Carcinoma, Squamous Cell
Anorectal Cancer

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2024-11-01

Last Posted Date: 2025-02-07

Lead Sponsor: University of Chicago

Target Recruit Count: 35

Registration Number: NCT06669572

Locations: 🇺🇸
o University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer.

Phase 2

Recruiting

Conditions: Persistent, Recurrent, or Metastatic Cervical Cancer

Interventions: Drug: Low-dose Pembrolizumab Plus Chemotherapy (Paclitaxel plus Carboplatin or Cisplatin)

First Posted Date: 2024-11-01

Last Posted Date: 2025-02-24

Lead Sponsor: Instituto Nacional de Cancer, Brazil

Target Recruit Count: 44

Registration Number: NCT06670911

Locations: 🇧🇷
Instituto Nacional de Cancer, Rio de Janeiro, RJ, Brazil

Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

Phase 3

Recruiting

Conditions: Clear Cell Renal Cell Carcinoma
Renal Cell Carcinoma (RCC)
Stage II Renal Pelvis Cancer AJCC v8
Stage III Renal Pelvis Cancer AJCC v8

Interventions: Biological: Pembrolizumab
Procedure: Biospecimen Collection
Drug: Tivozanib
Procedure: MRI
Procedure: Computed Tomography
Procedure: Biopsy
Other: Questionnaire Administration

First Posted Date: 2024-10-28

Last Posted Date: 2025-04-02

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 1040

Registration Number: NCT06661720

Locations: 🇺🇸
Beebe South Coastal Health Campus, Millville, Delaware, United States
🇺🇸
Helen F Graham Cancer Center, Newark, Delaware, United States
🇺🇸
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States

and more 59 locations

Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.

Phase 2

Not yet recruiting

Conditions: Colon Cancer

Interventions: Drug: Pembrolizumab Injection [Keytruda]
Procedure: Surgery
Procedure: Watch-and-wait approach
Drug: Adjuvant chemotherapy

First Posted Date: 2024-10-17

Last Posted Date: 2025-03-25

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 60

Registration Number: NCT06646445

Locations: 🇫🇷
Institut Sainte Catherine, Avignon, France
🇫🇷
CHU Besançon, Besançon, France
🇫🇷
IHFB Cognacq Jay, Levallois Perret, France

and more 7 locations

A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations

Phase 1

Recruiting

Conditions: Non-small Cell Lung Cancer
Lung Cancer

Interventions: Drug: valemetostat tosylate
Drug: pembrolizumab

First Posted Date: 2024-10-16

Last Posted Date: 2024-11-14

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 137

Registration Number: NCT06644768

Locations: 🇺🇸
University of California San Diego (Ucsd)-Moores Cancer Center, La Jolla, California, United States
🇺🇸
California Research Institute, Los Angeles, California, United States
🇺🇸
Valkyrie Clinical Trials, Los Angeles, California, United States

and more 38 locations