MedPath

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)

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Patients With Advanced Or Metastatic Merkel Cell Carcinoma

Phase 2
Not yet recruiting
Conditions
Advanced Or Metastatic Merkel Cell Carcinoma
Interventions
First Posted Date
2025-04-27
Last Posted Date
2025-04-27
Lead Sponsor
TuHURA Biosciences, Inc.
Target Recruit Count
118
Registration Number
NCT06947928

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

Phase 1
Not yet recruiting
Conditions
Inoperable Locally Advanced HER2-Negative Breast Cancer
Metastatic HER2-Negative Breast Cancer
Interventions
First Posted Date
2025-04-24
Last Posted Date
2025-04-30
Lead Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Target Recruit Count
180
Registration Number
NCT06942234

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)

Phase 1
Not yet recruiting
Conditions
Advanced Or Metastatic Merkel Cell Carcinoma
Interventions
First Posted Date
2025-04-23
Last Posted Date
2025-04-23
Lead Sponsor
TuHURA Biosciences, Inc.
Target Recruit Count
9
Registration Number
NCT06940440

A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer

Phase 3
Recruiting
Conditions
Non Squamous Non Small Cell Lung Cancer
Interventions
Drug: EU-approved Keytruda
First Posted Date
2025-04-23
Last Posted Date
2025-04-23
Lead Sponsor
Celltrion
Target Recruit Count
606
Registration Number
NCT06939595
Locations
🇬🇪

ltd "Institute of Clinical Oncology", Tbilisi, Georgia

Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )

Phase 1
Recruiting
Conditions
Small Cell Lung Cancer Extensive Stage
Merkel Cell Carcinoma
Interventions
First Posted Date
2025-04-22
Last Posted Date
2025-04-22
Lead Sponsor
Ariceum Therapeutics GmbH
Target Recruit Count
50
Registration Number
NCT06939036
Locations
🇺🇸

Biogenix Molecular, Miami, Florida, United States

Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma

Phase 2
Not yet recruiting
Conditions
Extrahepatic Cholangiocarcinoma
Perihilar Cholangiocarcinoma
Distal Cholangiocarcinoma
Resectable
Borderline Resectable
Interventions
First Posted Date
2025-04-11
Last Posted Date
2025-04-11
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
150
Registration Number
NCT06923475
Locations
🇳🇱

Amsterdam University Medical Center, Amsterdam, Netherlands

Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma

Phase 2
Not yet recruiting
Conditions
Classical Hodgkin Lymphoma
Interventions
First Posted Date
2025-04-08
Last Posted Date
2025-04-08
Lead Sponsor
University of Cologne
Target Recruit Count
50
Registration Number
NCT06916416

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Phase 1
Recruiting
Conditions
Non-Small Cell Lung Cancer
NSCLC
PDAC - Pancreatic Ductal Adenocarcinoma
CRC (Colorectal Cancer)
Metastatic Non-Small Lung Cell Cancer
Metastatic Colorectal Cancer (CRC)
KRAS G12A
KRAS G12C
KRAS G12D
KRAS G12S
Interventions
First Posted Date
2025-04-08
Last Posted Date
2025-05-04
Lead Sponsor
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Target Recruit Count
287
Registration Number
NCT06917079
Locations
🇺🇸

Sarah Cannon Research Institute at Mary Crowley, Dallas, Texas, United States

🇺🇸

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

NEXT Oncology, San Antonio, Texas, United States

and more 1 locations

A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

Phase 1
Not yet recruiting
Conditions
Advanced Solid Tumor
Interventions
First Posted Date
2025-04-04
Last Posted Date
2025-04-09
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
90
Registration Number
NCT06911827

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Phase 1
Not yet recruiting
Conditions
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasm Recurrence, Local
Neoplasm Metastasis
Recurrent Squamous Cell Carcinoma
Metastatic Squamous Cell Carcinoma
Interventions
First Posted Date
2025-04-04
Last Posted Date
2025-04-08
Lead Sponsor
University of Chicago
Target Recruit Count
36
Registration Number
NCT06912087
Locations
🇺🇸

University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

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