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 SKB264 in Combination with Pembrolizumab Versus Chemotherapy in Combination with Pembrolizumab As First-Line Treatment for PD-L1 Negative Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: SKB264
Drug: pemetrexed
Drug: Pembrolizumab
Drug: carboplatin or cisplatin

First Posted Date: 2024-12-02

Last Posted Date: 2024-12-02

Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Target Recruit Count: 432

Registration Number: NCT06711900

Locations: 🇨🇳
Shanghai Oriental Hospital, Shanghai, China

Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: BNT327
Drug: Carboplatin
Drug: Pemetrexed
Drug: Paclitaxel

First Posted Date: 2024-12-02

Last Posted Date: 2025-05-16

Lead Sponsor: BioNTech SE

Target Recruit Count: 982

Registration Number: NCT06712316

Locations: 🇺🇸
Alaska Oncology and Hematology, LLC, Anchorage, Alaska, United States
🇺🇸
Clermont Oncology Center, Clermont, Florida, United States
🇺🇸
Physicians Clinic of Iowa, Cedar Rapids, Iowa, United States

and more 44 locations

Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer

Phase 2

Recruiting

Conditions: Advanced Biliary Tract Cancer

Interventions: Drug: Surufatinib
Drug: Gemcitabine
Drug: Cisplatin
Drug: Durvalumab
Drug: Pembrolizumab

First Posted Date: 2024-11-27

Last Posted Date: 2024-11-27

Lead Sponsor: Dai, Guanghai

Target Recruit Count: 35

Registration Number: NCT06708858

Locations: 🇨🇳
Chinese PLA General Hospital, Beijing, Beijing, China

Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Patients With Initially Unresectable Stage III NSCLC

Phase 2

Not yet recruiting

Conditions: Non Small Cell Lung Cancer (Stage III)

Interventions: Drug: Sacituzumab tirumotecan plus pembrolizumab

First Posted Date: 2024-11-26

Last Posted Date: 2024-12-10

Lead Sponsor: Hunan Province Tumor Hospital

Target Recruit Count: 50

Registration Number: NCT06706219

Locations: 🇨🇳
Hunan Provincal Tumor Hospital, Changsha, Hunan, China

A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases

Phase 3

Recruiting

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Combination Product: ASP-1929 Photoimmunotherapy
Biological: Pembrolizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: 5-fluorouracil
Drug: Paclitaxel
Drug: Docetaxel

First Posted Date: 2024-11-21

Last Posted Date: 2025-05-04

Lead Sponsor: Rakuten Medical, Inc.

Target Recruit Count: 412

Registration Number: NCT06699212

Locations: 🇺🇸
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
🇨🇳
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan
🇨🇳
Taichung Veterans General Hospital, Taichung City, Taiwan

and more 9 locations

Safety and Efficacy of EIK1001-006 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.

Phase 2

Recruiting

Conditions: Advanced Melanoma

Interventions: Drug: Pembrolizumab (KEYTRUDA® )
Drug: EIK1001

First Posted Date: 2024-11-20

Last Posted Date: 2025-04-24

Lead Sponsor: Eikon Therapeutics

Target Recruit Count: 740

Registration Number: NCT06697301

Locations: 🇺🇸
The Oncology Institution of Hope and Innovation, Los Angeles, California, United States
🇺🇸
Bioresearch Partner, Hialeah, Florida, United States
🇦🇺
Cancer Care Wollongong, Wollongong, New South Wales, Australia

and more 9 locations

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

Phase 3

Recruiting

Conditions: Lung Cancer
Non-Small Cell Lung Cancer

Interventions: Biological: Pembrolizumab (+) Berahyaluronidase alfa
Biological: Pembrolizumab

First Posted Date: 2024-11-20

Last Posted Date: 2025-05-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 160

Registration Number: NCT06698042

Locations: 🇯🇵
Osaka International Cancer Institute ( Site 4005), Osaka, Japan
🇺🇸
Illinois Cancer Care ( Site 0101), Peoria, Illinois, United States
🇺🇸
Montefiore Medical Center ( Site 0104), Bronx, New York, United States

and more 52 locations