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 MK-4700 Alone or With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (MK-4700-001)

Phase 1

Recruiting

Conditions: Malignant Neoplasm

Interventions: Biological: MK-4700
Biological: Pembrolizumab

First Posted Date: 2025-03-25

Last Posted Date: 2025-05-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 82

Registration Number: NCT06894771

Locations: 🇮🇱
Rambam Health Care Campus ( Site 0201), Haifa, Israel
🇮🇱
Rabin Medical Center ( Site 0202), Petah Tikva, Israel
🇮🇱
Sheba Medical Center ( Site 0200), Ramat Gan, Israel

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Olomorasib
Drug: Pembrolizumab
Drug: Placebo
Drug: Durvalumab

First Posted Date: 2025-03-24

Last Posted Date: 2025-04-23

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 700

Registration Number: NCT06890598

Locations: 🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸
The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States

and more 318 locations

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Adagrasib
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed
Drug: Placebo
Drug: Cisplatin

First Posted Date: 2025-03-13

Last Posted Date: 2025-05-14

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 630

Registration Number: NCT06875310

Locations: 🇲🇽
Local Institution - 0638, Puebla, Mexico
🇧🇪
Local Institution - 0215, Hasselt, Limburg, Belgium
🇲🇽
Local Institution - 0181, Puebla, Mexico

and more 322 locations

Evaluation of JSKN016 Combination Therapy in Subjects with NSCLC

Phase 1

Not yet recruiting

Conditions: Advanced Non-small Cell Lung Cancer

Interventions: Drug: JSKN016
Drug: Carboplatin
Drug: Furmonertinib Mesylate
Drug: Ivonescimab
Drug: Docetaxel
Drug: Tislelizumab
Drug: Pembrolizumab

First Posted Date: 2025-03-11

Last Posted Date: 2025-03-11

Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Target Recruit Count: 288

Registration Number: NCT06868732

TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

Phase 1

Not yet recruiting

Conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Nasopharyngeal Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Metastatic Sinonasal Squamous Cell Carcinoma

Interventions: Biological: Autologous Tumor Membrane Vesicles Vaccine
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Biological: Pembrolizumab
Procedure: Surgical Procedure

First Posted Date: 2025-03-11

Last Posted Date: 2025-05-11

Lead Sponsor: Emory University

Target Recruit Count: 12

Registration Number: NCT06868433

Locations: 🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small Cell Lung

Interventions: Biological: Rilvegostomig
Biological: Pembrolizumab

First Posted Date: 2025-03-10

Last Posted Date: 2025-05-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 830

Registration Number: NCT06868277

Locations: 🇬🇧
Research Site, Blackpool, United Kingdom

Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype

Phase 2

Not yet recruiting

Conditions: Richter Syndrome
Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Drug: Nemtabrutinib
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Other: Questionnaire Administration