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

CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS3]

Completed

Conditions: Metastatic Nonsmall Cell Lung Cancer

Interventions: Drug: Pemetrexed
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Cisplatin

First Posted Date: 2024-09-23

Last Posted Date: 2024-09-23

Lead Sponsor: Aetion, Inc.

Target Recruit Count: 851

Registration Number: NCT06607393

Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer

Phase 2

Not yet recruiting

Conditions: Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2024-09-20

Last Posted Date: 2025-04-01

Lead Sponsor: MedSIR

Target Recruit Count: 30

Registration Number: NCT06604858

A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Phase 3

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: AK117 in combination with AK112
Drug: Placebo in combination with Pembrolizumab

First Posted Date: 2024-09-19

Last Posted Date: 2024-11-14

Lead Sponsor: Akeso

Target Recruit Count: 510

Registration Number: NCT06601335

Locations: 🇨🇳
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
🇨🇳
West China Hospital of Sichuan University, Chengdu, Sichuan, China

A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Phase 1

Recruiting

Conditions: Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma

Interventions: Drug: ALN-BCAT
Drug: Pembrolizumab

First Posted Date: 2024-09-19

Last Posted Date: 2025-05-14

Lead Sponsor: Alnylam Pharmaceuticals

Target Recruit Count: 158

Registration Number: NCT06600321

Locations: 🇺🇸
Clinical Trial Site, San Antonio, Texas, United States

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

Phase 3

Recruiting

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Refractory Hypopharyngeal Squamous Cell Carcinoma
Refractory Laryngeal Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Refractory Head and Neck Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
Recurrent Oral Cavity Squamous Cell Carcinoma

Interventions: Procedure: Biospecimen Collection
Biological: Cetuximab
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Positron Emission Tomography

First Posted Date: 2024-09-19

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 158

Registration Number: NCT06589804

Locations: 🇺🇸
Fremont - Rideout Cancer Center, Marysville, California, United States
🇺🇸
Lutheran Hospital - Cancer Centers of Colorado, Golden, Colorado, United States
🇺🇸
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

and more 83 locations

CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS4]

Completed

Conditions: Metastatic Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin

First Posted Date: 2024-09-05

Last Posted Date: 2024-09-05

Lead Sponsor: Aetion, Inc.

Target Recruit Count: 304

Registration Number: NCT06585189

Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1

Phase 1

Not yet recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Trabedersen
Drug: Pembrolizumab

First Posted Date: 2024-08-30

Last Posted Date: 2025-04-10

Lead Sponsor: University of Nebraska

Target Recruit Count: 45

Registration Number: NCT06579196

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck
Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8