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)

Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Phase 2
Recruiting
Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8
Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Nasopharyngeal Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Metastatic Paranasal Sinus Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
First Posted Date
2024-10-15
Last Posted Date
2025-01-20
Lead Sponsor
Emory University
Target Recruit Count
28
Registration Number
NCT06636734
Locations
🇺🇸

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes

Phase 2
Not yet recruiting
Conditions
HPV-Related Carcinoma
Uterine Cervical Cancer
Anal Canal Cancer
HPV-Related Anal Squamous Cell Carcinoma
HPV-Related Cervical Carcinoma
Interventions
Diagnostic Test: ctDNA test
First Posted Date
2024-10-14
Last Posted Date
2024-10-14
Lead Sponsor
Instituto do Cancer do Estado de São Paulo
Target Recruit Count
150
Registration Number
NCT06640283
Locations
🇧🇷

Instituto do Câncer do Estado de São Paulo - ICESP, São Paulo, Brazil

Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

Phase 3
Recruiting
Conditions
PD-L1-positive Metastatic NSCLC
Interventions
First Posted Date
2024-10-10
Last Posted Date
2025-03-04
Lead Sponsor
Genmab
Target Recruit Count
702
Registration Number
NCT06635824
Locations
🇫🇷

CHU Rennes - Hopital Pontchaillou, Rennes, France

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Avera Cancer Institute, Sioux Falls, South Dakota, United States

and more 29 locations

Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

Phase 3
Recruiting
Conditions
Resectable Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Interventions
Procedure: Surgical Procedure
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
First Posted Date
2024-10-09
Last Posted Date
2025-03-30
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
1100
Registration Number
NCT06632327
Locations
🇺🇸

South Sacramento Cancer Center, Sacramento, California, United States

🇺🇸

Kaiser Permanente-San Francisco, San Francisco, California, United States

🇺🇸

Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, United States

and more 223 locations

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

Phase 3
Recruiting
Conditions
Non-squamous Non-small Cell Lung Cancer
Interventions
First Posted Date
2024-10-04
Last Posted Date
2025-05-07
Lead Sponsor
AstraZeneca
Target Recruit Count
878
Registration Number
NCT06627647
Locations
🇻🇳

Research Site, Vinh, Vietnam

A Trial of LNS8801 with or Without Pembrolizumab in Patients with Refractory Melanoma

Phase 2
Not yet recruiting
Conditions
Melanoma (Skin Cancer)
Melanoma Stage IIIB-IV
Cutaneous Melanoma
Unresectable Melanoma
Interventions
Drug: Chemotherapy (dacarbazine or temozolomide)
Biological: Immunotherapy (Pembrolizumab)
Biological: Immunotherapy (nivolumab and relatlimab)
Biological: Immunotherapy (ipilimumab and nivolumab)
First Posted Date
2024-10-03
Last Posted Date
2024-10-08
Lead Sponsor
Linnaeus Therapeutics, Inc.
Target Recruit Count
135
Registration Number
NCT06624644

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

First Posted Date
2024-10-02
Last Posted Date
2025-05-15
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
680
Registration Number
NCT06623422
Locations
🇺🇸

Providence St. Jude Medical Center ( Site 0106), Fullerton, California, United States

🇺🇸

Ellis Fischel Cancer Center ( Site 0133), Columbia, Missouri, United States

🇺🇸

Lake Regional Hospital-Cancer Center ( Site 0123), Osage Beach, Missouri, United States

and more 76 locations

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Phase 1
Recruiting
Conditions
Lung Cancer
Interventions
First Posted Date
2024-10-01
Last Posted Date
2025-05-20
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
218
Registration Number
NCT06618287
Locations
🇺🇸

Local Institution - 0066, Birmingham, Alabama, United States

🇦🇺

Liverpool Hospital, Liverpool, New South Wales, Australia

🇨🇦

The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

and more 44 locations

Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer

Phase 3
Not yet recruiting
Conditions
Breast Cancers
Triple Negative Breast Cancer (TNBC)
Interventions
Other: Deescalation
First Posted Date
2024-09-23
Last Posted Date
2025-02-21
Lead Sponsor
UNICANCER
Target Recruit Count
2454
Registration Number
NCT06606730

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Phase 1
Recruiting
Conditions
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Colorectal Cancer
Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
First Posted Date
2024-09-23
Last Posted Date
2025-04-22
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
750
Registration Number
NCT06607185
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Mayo Clinic, Phoenix, Arizona, United States

🇺🇸

City of Hope, Duarte, California, United States

and more 49 locations
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