Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

Chemical Formula: -

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)

Associated Therapies: -

Clinical Trials

Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

Phase 2

Recruiting

Conditions: Stage IV Pancreatic Cancer AJCC v8
Metastatic Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Olaparib
Biological: Pembrolizumab

First Posted Date: 2020-09-16

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 88

Registration Number: NCT04548752

Locations: 🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸
Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
🇺🇸
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

and more 531 locations

PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %

Phase 3

Active, not recruiting

Conditions: Non-small-cell Lung Cancer

Interventions: Drug: Pembrolizumab and Chemotherapy drugs
Drug: Pembrolizumab

First Posted Date: 2020-09-14

Last Posted Date: 2024-08-09

Lead Sponsor: University Hospital, Brest

Target Recruit Count: 349

Registration Number: NCT04547504

Locations: 🇫🇷
CHRU de Brest, Brest, France
🇫🇷
Centre Léon Berard, Lyon, France
🇫🇷
CH MEAUX, Meaux, France

and more 26 locations

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

Phase 2

Withdrawn

Conditions: Metastatic HPV-16 Positive Squamous Cell Anal Cancer

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Drug: Pembrolizumab (KEYTRUDA(R))
Biological: Individual Patient TCR-Transduced PBL

First Posted Date: 2020-09-03

Last Posted Date: 2021-02-01

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT04536922

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

Phase 2

Recruiting

Conditions: Unresectable Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Cancer
Recurrent Head and Neck Cancer

Interventions: Biological: BNT113
Biological: Pembrolizumab

First Posted Date: 2020-09-01

Last Posted Date: 2024-12-19

Lead Sponsor: BioNTech SE

Target Recruit Count: 285

Registration Number: NCT04534205

Locations: 🇧🇷
Fundacao Universidade de Caxias do Sul - Instituto de Pesquisas em Saude IPS-UCS, Caxias Do Sul, Brazil
🇧🇷
Hospital Erasto Gaertner, Curitiba, Brazil
🇧🇷
Hospial de Caridade de Ijui, Ijuí, Brazil

and more 175 locations

Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Lung Adenocarcinoma
Stage IV Lung Cancer AJCC v8
Metastatic Lung Adenocarcinoma
Metastatic Lung Non-Small Cell Carcinoma
Stage IVB Lung Cancer AJCC v8
Recurrent Lung Non-Small Cell Carcinoma
Stage IVA Lung Cancer AJCC v8

Interventions: Drug: Pembrolizumab
Other: Comprehensive Geriatric Assessment
Drug: Pemetrexed
Other: Questionnaire Administration
Drug: Carboplatin
Other: Quality-of-Life Assessment

First Posted Date: 2020-08-31

Last Posted Date: 2024-04-09

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 101

Registration Number: NCT04533451

Locations: 🇺🇸
Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
🇺🇸
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
🇺🇸
ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, United States

and more 502 locations

Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC

Phase 2

Terminated

Conditions: Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)

Interventions: Drug: SAR408701 (Tusamitamab ravtansine)
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2020-08-24

Last Posted Date: 2025-01-10

Lead Sponsor: Sanofi

Target Recruit Count: 57

Registration Number: NCT04524689

Locations: 🇪🇸
Investigational Site Number : 7240005, La Coruña, A Coruña [La Coruña], Spain
🇪🇸
Investigational Site Number : 7240006, Badalona, Catalunya [Cataluña], Spain
🇧🇷
Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004, Natal, Rio Grande Do Norte, Brazil

and more 24 locations

Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer

Phase 1

Active, not recruiting

Conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Localized Gastroesophageal Junction Adenocarcinoma
Locally Advanced Gastroesophageal Junction Adenocarcinoma
Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions: Drug: Docetaxel
Drug: Fluorouracil
Drug: Oxaliplatin
Biological: Pembrolizumab
Radiation: Radiation Therapy

First Posted Date: 2020-08-21

Last Posted Date: 2024-10-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT04522336

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)

Phase 1

Active, not recruiting

Conditions: Malignant Epithelial Neoplasms

Interventions: Biological: TCR-transduced T cells
Drug: CDX-1140
Drug: Pembrolizumab

First Posted Date: 2020-08-20

Last Posted Date: 2024-08-23

Lead Sponsor: Providence Health & Services

Target Recruit Count: 24

Registration Number: NCT04520711

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)

Phase 1

Terminated

Conditions: Neoplasm Metastasis

Interventions: Biological: Gebasaxturev
Drug: Pembrolizumab

First Posted Date: 2020-08-20

Last Posted Date: 2024-10-01

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 76

Registration Number: NCT04521621

Locations: 🇫🇷
Hopital La Timone ( Site 0051), Marseille, Bouches-du-Rhone, France
🇨🇦
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0032), Montreal, Quebec, Canada
🇩🇪
Universitaetsklinikum Tuebingen ( Site 0171), Tuebingen, Baden-Wurttemberg, Germany

and more 26 locations

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Phase 1

Recruiting

Conditions: Advanced Solid Malignancies

Interventions: Drug: CFI-402411
Drug: Pembrolizumab

First Posted Date: 2020-08-20

Last Posted Date: 2024-04-10

Lead Sponsor: Treadwell Therapeutics, Inc

Target Recruit Count: 170

Registration Number: NCT04521413

Locations: 🇺🇸
The Angeles Clinic, Los Angeles, California, United States
🇺🇸
SCRI - Nashville, Nashville, Tennessee, United States
🇺🇸
MD Anderson, Houston, Texas, United States

and more 10 locations

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